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Study objective The first ever report of vaginal natural orifice transluminal endoscopic surgery (vNOTES) for benign gynaecological was reported in 2012. There has been an exponential uptake of the number of surgeons performing such procedures worldwide with no official guidance to ensure the safe implementation of this technique into gynaecological practice due its recency. The objective of this study is to report an international consensus-based statement to help guide a basis for adopting vNOTES into clinical practice. Study design The consensus-based statement was developed amongst 39 international experts using the Delphi methodology over three successive rounds. Consensus was pre-defined as an agreement of 80% or more by the experts. Consensus sought over eight key concepts pertaining to vNOTES including patient selection, perioperative management, surgical technique, instruments, anatomy, training, registries and trials and definition of the surgical technique. Recommendations from an expert anaesthetist and urogynaecologist were also sought to give a broader perspective with respect to the implementation of vNOTES. Results Fifty nine international surgeons were invited to participate and 39 (66%) agreed to participate based on being involved in a minimum of 20 vNOTES procedures. They were from 13 countries across 5 continents (Europe, North America, South America, Australia and Asia). Participation was 100% on all three rounds. Overall, consensus was reached in 50 of the 56 questions (89%) with the remaining 6 questions where consensus was not reached pertaining to the domain of patient selection. Conclusion An international expert based vNOTES statement is presented here to help guide adoption of vNOTES based on the experience of early adopters. Consensus was achieved on most components of this consensus statement. Given the recency of this technique, until high-level evidence becomes available, this statement provides an appropriate guidance to the safe implementation of vNOTES into gynaecological practice.

Objective To compare adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) versus laparoscopy. Design Parallel group, 1:1 single-centre single-blinded randomised trial, designed as non-inferiority study with a margin of 15%. Setting Belgian teaching hospital POPULATION: Non-pregnant non-virgin women with an intact uterus and without obliteration of the pouch of Douglas scheduled to undergo removal of an adnexal mass assessed to be benign on ultrasound by IOTA criteria. Methods Randomisation to laparoscopy (control group) or vNOTES (experimental group). Stratification according to adnexal size. Blinding of participants and outcome assessors by sham incisions. Main outcome measures The primary outcome measure was adnexectomy by the allocated technique. Secondary outcomes included duration of surgery, pain scores and analgesics used, quality of life and adverse events. Results We randomly assigned 67 participants (34 to the vNOTES group and 33 to the laparoscopy group). The primary endpoint was always reached in both groups: there were no conversions. We performed a sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the laparoscopy group: the one-sided 95% upper limit for the differences in proportions of conversion was estimated as 13%, which is below the predefined non-inferiority margin of 15%. The secondary outcomes demonstrated a shorter duration of surgery, lower pain scores, lower total dose of analgesics and a trend for more adverse events in the vNOTES group. Conclusions vNOTES is non-inferior to laparoscopy for a successful adnexectomy without conversion. vNOTES allowed shorter operating times and less postoperative pain but there was a trend for more adverse events.

Study Objective The Hominis surgical system is a novel robot-assisted system, designed specifically for robotic vaginal natural orifice transluminal endoscopic surgery (RvNOTES). We presented our experience of the first 30 RvNOTES hysterectomies assessing the feasibility and safety of this technology. Design A two-center prospective study. Setting Academic tertiary referral centers. The ethics committees approved the study in both centers. Patients Thirty women with benign indication for hysterectomy. Intervention RvNOTES hysterectomy performed by the Hominis surgical system. Measurements and Main Results The primary outcome of the study was the rate of conversion to open or conventional laparoscopic approaches. Secondary outcomes included intra- and postoperative adverse events, operative time, estimated blood loss, length of hospital stay, and 6-week follow-up assessment. A total of 15 women were enrolled at each site. The median age was 59 years (range: 37–79) and the median body mass index was 25.4 kg/m2 (range: 17.6–40.0). Twenty-four women (80%) had comorbidities. All the procedures were completed successfully without conversion to open abdominal, traditional vaginal, or conventional laparoscopic surgery. No intraoperative complications were observed. Median blood loss and procedure duration were 50 mL (range: 20–400) and 57 minutes (range: 24–88), respectively. Postoperative pain was minimal, with a median visual analog scale of 3 (range: 1–5) for the first 24 hours following surgery. The median hospital stay was 3 days (range: 2–8). According to the treating physicians’ evaluations, the vaginal cuff was fully healed in all patients at the 6-week postoperative follow-up visit. Conclusions This is the first publication of robot-assisted vaginal hysterectomy using the Hominis surgical system. The positive results of this study show this new technology to be a safe and effective tool for vaginal natural orifice transluminal endoscopic surgery, enabling surgeons to operate vaginally with the known advantages of robotic modality.

Trans-vaginal natural orifice transluminal endoscopic surgery (vNOTES) is a recently popularised minimally invasive surgical procedure, aimed at minimising abdominal wall scars and improving pain and patient recovery times. Although vNOTES has been studied in the context of post-operative pain and cosmesis, women’s acceptance of the technique has only been cursorily examined. In this survey-based observational study, we assessed the acceptability of this technique among a cohort of Middle Eastern women. A cohort of 175 Middle Eastern women were surveyed using a 13-item questionnaire at a single gynaecology centre. The survey used was a translated version of a questionnaire from a previous study (1) and comprised open-response, five-point Likert Scale and agree-disagree items. Among 175 Middle Eastern women participated in this study most of them holding neutral view on abdominal and gynaecological procedures via vagina. 47% of participants were unsure regarding the effect of surgery via vagina on their sexual function. Although 61% of the participants showed no preference towards vNOTES over laparoscopic cholecystectomy, more than half of them indicated preference if vNOTES shown to be as effective and safe as laparoscopic cholecystectomy. The gender of the surgeon was shown to have no influence on the perspectives of the majority of participants to undergo vNOTES. vNOTES may hold value for women who have conservative upbringing and/or value cosmesis. This study provides information regarding Middle Eastern women’s perspectives on vNOTES, which may be of considerable clinical use as the popularity of this surgical technique continues to increase.

STUDY OBJECTIVE To evaluate the safety and feasibility of vaginal natural orifice transluminal endoscopic surgery (vNOTES) for benign gynaecological indications. STUDY DESIGN Prospective observational study (Canadian Task Force classification II-3) in a non-university teaching hospital. One thousand consecutive patients (2013-2018) who were eligible for vNOTES approach to benign gynaecological surgery were included. RESULTS Patient data and perioperative outcomes were included for analysis after the vNOTES surgical approach was standardized and made the default route of surgery. Of the 1000 vNOTES cases performed during this study period, hysterectomy (73%) was the most common followed by adnexal surgery (18%) and salpingectomy (4%). The mean age of the patient cohort was 46 yrs of age (22-83) and mean BMI, 26 kg/m2(16.5-52). There was a conversion rate of 0.4% (4 cases), 3 to conventional laparoscopy and 1 to laparotomy. The mean operating time was 42 minutes (14-250 minutes). The total complication rate was 3.9% (39) of which 1% (10) was intraoperative complications and 2.9% (29) were post-operative complications. When the hysterectomy cohort was sub analyzed, the total complication rate was 5.2% in this group (intraoperative 1.4% and post-operative 3.8%) with only a 0.4% complication rate in the non-hysterectomy sub-group. Of the complications in the hysterectomy group there were 9 cystotomies (1.2%). The mean specimen weight for all hysterectomies was 172 g (20-3361 g) with an average operating time of 46 minutes (20-250). CONCLUSION The perioperative outcomes of this large vNOTES case series for benign gynaecological indications is comparable to other vNOTES procedures reported in the literature apart from the risk of cystotomy which is a hysterectomy specific risk. The outcomes are that of a single high-volume surgeon incorporating cases within his respective learning curve of the surgical technique and as such should be interpreted accordingly. Since 2015 the International NOTES Society has initiated a prospective complication database where all vNOTES surgeons are invited to register their cases.

OBJECTIVE The aim of this study was to describe our experience with transvaginal natural orifice transluminal endoscopic surgery (vNOTES) uterosacral ligament suspension (USLS) and to evaluate the learning curve of mastering the skills to operate this procedure. METHODS This is a prospective study of the first 35 vNOTES hysterectomy and USLS surgeries performed between October 2018 and April 2019 at Rambam Health Care Campus (Israel) (n = 26) and Imelda Hospital (Belgium) (n = 9). The primary outcome was surgical time. Secondary outcomes included intraoperative bleeding, length of hospitalization, pain during the first 24 hours postoperative pain, and the need for analgesia, intraoperative, and postoperative adverse events. RESULTS The median age was 55 years (range, 40-81). The median operative time was 113 minutes (range, 89-233). For the procedures performed at Rambam, total operative time decreased from the first 13 to the following 13: from 149 minutes (range, 89-233 minutes) to 103 (89-170) (

Background and objective Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) has been applied massively in the gynecological field in recent years. The aim of the current study is to present the surgical technique of vNOTES omentectomy and to evaluate the feasibility of this procedure. Methods A case series study of the first 5 vNOTES omentectomy procedures performed for surgical staging of suspicious early stage ovarian cancer, at Rambam Health Care Campus (Israel) and Imelda Hospital (Belgium) between November 2018 and August 2019. Sociodemographic and clinical data were retrieved from patients’ electronic charts. Primary points of interest included intra-operative bleeding, length of surgery, length of hospitalization, and surgical complications. Results The median age was 61 years (range 50–72), and the median BMI was 27 kg/m2 (range 23–33). All the operations were carried out to completion through the vaginal GelPOINT, without insertion of an assistant abdominal trocar or conversion to another surgical approach. The median omentectomy time was 45 min (range: 39–52). The median estimated intraoperative blood loss was 150 ml (range: 20–200). The median hospital stay was 2 days (range: 1–3). Conclusions vNOTES is a feasible technique for omentectomy in early stage ovarian cancer, with low rates of complications and improved cosmetic results.

Vaginal natural orifice transluminal endoscopic surgery (NOTES) is a novel technique for minimally invasive gynecological surgery. Adequate training and standardization are key elements to patient safety and quality of care. Based on consensus statements and expert opinion; we report a step-by-step guidance for hysterectomy via natural orifice transluminal endoscopy. A detailed description is presented of pre- and postoperative care, and the instruments and equipment used, and surgical steps are illustrated by photographic images. This report can guide surgeons in their training to perform a hysterectomy via NOTES. ispartof: ACTA OBSTETRICIA ET GYNECOLOGICA SCANDINAVICA vol:101 issue:6 pages:649-656 ispartof: location:United States status: published

Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is a minimally invasive, scar-free technique that uses a vaginal colpotomy to access the peritoneal cavity. Hysterectomy via vNOTES has shown to be technically feasible and safe, with shorter hospital stay and lower postoperative pain scores. Moreover, vNOTES adds the advantages of endoscopy to those of vaginal surgery and thereby broadens the indications of a conventional vaginal hysterectomy. Virginity has been contraindicated for vNOTES so far, as vaginal accessibility can be severely reduced in virgin women. Therefore, cases of vNOTES hysterectomy in virgin patients have never been reported in the literature. The objective of this study is to assess the technical feasibility and safety of hysterectomy in virgin women. We performed a retrospective analysis of patient files of all vNOTES hysterectomies performed on virgin women in our centre (Imelda Hospital, Bonheiden, Belgium) from July 2016 until June 2020 (N = 9). Despite limited vaginal accessibility, vNOTES hysterectomy was successfully performed in all nine patients, without conversion to laparoscopy or laparotomy and without clinically relevant complications. In this first IDEAL stage 1 study, vaginal NOTES hysterectomy appears to be technically feasible and safe in virgin women.Impact statementWhat is already known on this subject? Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is an emerging, minimally invasive technique that offers a safe alternative to laparoscopy and open surgery. Besides better cosmetics (scar-free technique), advantages of vNOTES hysterectomy include shorter hospital stay and less postoperative pain compared to laparoscopic hysterectomy. Moreover, vNOTES adds the benefits of endoscopy (visualisation of anatomy) to conventional vaginal hysterectomy. Virginity has been contraindicated for vNOTES so far, because the absence of uterine descent and narrow vagina in virgins is thought to complicate the vaginal approach. Therefore, vNOTES hysterectomy has never been reported in virgin patients.What do the results of this study add? In this study, we are the first to report the feasibility of performing a vNOTES hysterectomy in virgin patients. The results show that, in experienced hands, indications for vNOTES can be broadened and include virgin women.What are the implications of these findings for clinical practice and/or further research? This first report of vNOTES hysterectomy in virgin patients is only a small but important step in the evaluation of safety and efficacy of this emerging technique. Further research is needed to assess reproducibility of the findings and to carefully determine indications and contraindications of vNOTES.

Study Objective: Vaginal natural orifice transluminal endoscopic surgery (vNOTES) is a novel minimal invasive surgical technique allowing a variety of gynecological procedures. The current literature describes improved patient comfort, improved better cosmetic results, and reduced operation time. This is a first study to assess pregnancy outcome after fertility-preserving vNOTES procedures. Design/Participants/Materials/Setting/Methods: We performed a retrospective observational cohort study including 125 patients under 43 years that underwent fertility-preserving vNOTES over a 5-year period (2014–2019). The gynecological surgical procedures included were vNOTES myomectomy, vNOTES salpingectomy for ectopic pregnancy, vNOTES unilateral adnexectomy, and vNOTES cystectomy. A total of 26 pregnancies in 21 cases were observed, with deliveries between 2015 and 2020. Results: Retrospective analysis in this patient group showed that 18 pregnancies were diagnosed within 1 year after vNOTES (85.7%). Mean interval between surgery and pregnancy was 6 months. Fertility treatment was performed in 28.6%. In the 26 observed pregnancies, no vNOTES-related complications were observed and delivery was at term in all cases. Mode of delivery was a vaginal delivery in twenty cases (76.9% of total) of which 2 cases vacuum assisted (7.7%) and a Caesarean section in 6 cases (23.1% of total). Two cases of trial of labor after Caesarean are described after vNOTES surgery, both ended in an uncomplicated vaginal delivery. In case of vaginal delivery, the perineum was intact in 15%, a mediolateral episiotomy was performed in 50 and 35% a grade 1–2 perineal rupture was described. No grade 3–4 perineal ruptures are described. Limitations: A limitation of this study is the retrospective design which does not correct for confounding factors. Further larger multicenter studies are needed to validate these data. Conclusions: This is the first study describing pregnancy outcome after fertility-preserving vNOTES procedures. vNOTES did not affect the mode of delivery or cause pregnancy-related complications. vNOTES did not increase the risk of extensive perineal tears during vaginal delivery. These preliminary data show no adverse events when vNOTES is performed in women of reproductive age. Posterior colpotomy as performed in all vNOTES procedures is by itself not an indication for an elective Caesarean section.

This is a first feasibility on vaginal natural orifice transluminal endoscopic surgery (vNOTES) in patients with prior hysterectomy. Our aim was to gain initial experience on performing vNOTES surgery on prior hysterectomy cases, whereby the main concern is that pelvic adhesions may impede safe transvaginal access. Between January 2017 and February 2020, a single surgeon (J.B.) performed vNOTES surgery on nine patients with a history of hysterectomy. Conventional laparoscopic instruments were inserted transvaginally through a vNOTES port. No abdominal incisions were made. Patient data and perioperative data were analyzed. Mean operating time was 38 minutes and there were no operative complications. Postoperative pain scores were low. The mean size of the adnexal cysts that were removed was 26 mm. In this study, vNOTES surgery was successfully performed in nine patients with prior hysterectomy. Following the IDEAL principles, it is important to report on our initial findings of this IDEAL stage 1 study. The results warrant further investigation in IDEAL stage 2 studies but do not validate the widespread use of this approach.

vNOTES or vaginal Natural Orifice Transluminal Endoscopic surgery is a new paradigm shift in gynaecological surgery. A first paradigm shift from conventional surgery into laparoscopic surgery was firstly observed in the 1980s and 1990s. vNOTES may represent a shift from 90° to parallel surgery. Almost all benign gynaecological operations can be performed via vNOTES. The chapter presents the technique of vNOTES along with results of various benign and mainly malignant cases. In parallel, the clinical approach of endometrial cancer is widely discussed.

ispartof: FUTURE SCIENCE OA vol:6 issue:7 ispartof: location:England status: published

Objectives: Vaginal natural orifice transluminal endoscopic surgery (vNOTES) is an emerging minimally invasive technique in benign gynaecologic surgery whereby surgical access to the peritoneal cavity is achieved through natural orifices, namely through a vaginal colpotomy. Experience in repeat vNOTES cases is limited and so far, repeat vNOTES cases have not been described in the literature. The purpose of this study was to demonstrate the feasibility of vNOTES hysterectomy in women with a history of previous vNOTES adnexal surgery. Design: We performed a retrospective cohort study of the first 11 repeat vNOTES cases in our centre. All vNOTES procedures, primary adnexal surgery as well as repeat vNOTES hysterectomy, were performed by one surgeon (J.B.). Materials, Setting, Methods: Between March 2016 and May 2020, 11 patients underwent a vNOTES hysterectomy after prior vNOTES adnexectomy or cystectomy in Imelda Hospital, Bonheiden, Belgium. Relevant patient characteristics and outcome data were collected after written informed consent. Results: Median age was 49 years (range 44–65) at the moment of the first vNOTES procedure. Two patients had one or more caesarean sections in history, and 2 women were nulliparous. Median interval between primary and repeat vNOTES procedure was 15 months (range 0.8–37 months). All patients underwent a vaginally assisted NOTES hysterectomy (VANH) as repeat vNOTES procedure. Performing a colpotomy and entering the peritoneal cavity after prior vNOTES was technically feasible in all cases. All VANHs were successfully performed. There were 3 minor complications after repeat vNOTES, of which one was anaesthesia-related. The 2 complications associated with the surgical procedure were both cystitis. In one of these 2 patients, there were high post-void residues, which were easily managed by bladder training. There were no conversions to laparoscopy or laparotomy, neither serious nor life-threatening complications. No ureteric, bladder, or intestinal injuries have occurred. Limitations: The retrospective design and small sample size are the main limitations of this study. Moreover, the follow-up period of the most recently operated patients was too short to draw conclusions on long-term outcomes, including sexual function. Conclusions: In all patients in this case series, vNOTES hysterectomy after prior vNOTES adnexal surgery was successfully performed. Large-scale prospective trials with long-term follow-up are needed to evaluate the safety and feasibility of multiple consecutive vNOTES procedures in 1 patient.

Study Objective To evaluate the outcome of hysterectomy through vaginal natural orifice transluminal endoscopic surgery (vNOTES) in cases with a large uterus. Design A retrospective cohort study. Setting Belgian teaching hospital. Patients Women who underwent a vNOTES hysterectomy from March 2015 to March 2020 for benign gynecologic disease with a uterine weight of 280 g or more on pathologic examination (N = 114). Interventions All women underwent vaginally assisted NOTES hysterectomy. We performed a retrospective analysis of baseline patient characteristics and clinical outcomes. Measurements and Main Results The mean age was 50 ± 3.5 years. Twenty-two (19%) patients were obese (body mass index ≥30 kg/m2), and 4 (3.5%) were morbidly obese (body mass index ≥40 kg/m2). Thirty-five (31%) patients were nulliparous, and 15 (13%) women had 1 or more cesarean sections in their medical history. Uterine weight varied from 281 g to 3361 g, with a mean weight of 559 ± 425 g. Mean surgical time was 63 ± 34 minutes. Surgical time was positively associated with uterine size. There were 4 complications: 3 bleeding complications in the first 24 hours after surgery and 1 minor late complication. Conversion to laparotomy for specimen extraction was performed in 1 case (conversion rate 0.9%). There were no conversions to laparoscopy. No ureteric, bladder, or intestinal injuries occurred in this case series, and there were neither life-threatening complications nor intensive care unit admissions. Conclusion The vNOTES technique can offer a safe and effective alternative to laparoscopy or laparotomy in cases with a large to very large uterus, even if the patient has a history of cesarean section, obesity, or nulliparity. In 99% of all women in this study, hysterectomy was successfully performed through vNOTES without conversion. By making use of the advantages of endoscopic surgery, vNOTES might broaden the indications of vaginal hysterectomy. Randomized controlled trials are needed to evaluate whether vaginally assisted NOTES hysterectomy is superior to laparoscopic or abdominal hysterectomy in large uteri cases.

Trans-vaginal natural orifice transluminal endoscopic surgery (vNOTES) is a recently popularised minimally invasive surgical procedure, aimed at minimising abdominal wall scars and improving pain and patient recovery times. Although vNOTES has been studied in the context of post-operative pain and cosmesis, women's acceptance of the technique has only been cursorily examined. In this survey-based observational study, we assessed the acceptability of this technique among a cohort of Middle Eastern women.A cohort of 175 Middle Eastern women were surveyed using a 13-item questionnaire at a single gynaecology centre. The survey used was a translated version of a questionnaire from a previous study (1) and comprised open-response, five-point Likert Scale and agree-disagree items.Among 175 Middle Eastern women participated in this study most of them holding neutral view on abdominal and gynaecological procedures via vagina. 47% of participants were unsure regarding the effect of surgery via vagina on their sexual function. Although 61% of the participants showed no preference towards vNOTES over laparoscopic cholecystectomy, more than half of them indicated preference if vNOTES shown to be as effective and safe as laparoscopic cholecystectomy. The gender of the surgeon was shown to have no influence on the perspectives of the majority of participants to undergo vNOTES.vNOTES may hold value for women who have conservative upbringing and/or value cosmesis. This study provides information regarding Middle Eastern women's perspectives on vNOTES, which may be of considerable clinical use as the popularity of this surgical technique continues to increase.

OBJECTIVE: To compare hysterectomy by transvaginal natural orifice transluminal endoscopic surgery (vNOTES) versus total laparoscopic hysterectomy (TLH) as a day-care procedure. DESIGN: Parallel group, 1:1 randomised single-centre single-blinded trial, designed as a non-inferiority study with a margin of 15%. SETTING: Belgian teaching hospital. POPULATION: Women aged 18-70 years scheduled to undergo hysterectomy for benign indications. METHODS: Randomisation to TLH (control group) or vNOTES (experimental group). Stratification according to uterine volume. Blinding of participants and outcome assessors. MAIN OUTCOME MEASURES: The primary outcome was hysterectomy by the allocated technique. We measured the proportion of women leaving within 12 hours after hysterectomy and the length of hospital stay as secondary outcomes. RESULTS: We randomly assigned 70 women to vNOTES (n = 35) or TLH (n = 35). The primary endpoint was always reached in both groups: there were no conversions. We performed a sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the TLH group: the one-sided 95% upper limit for the differences in proportions of conversion was estimated as 7.5%, which is below the predefined non-inferiority margin. More women left the hospital within 12 hours after surgery after vNOTES: 77 versus 43%, difference 34% (95% CI 13-56%), P = 0.007. The hospital stay was shorter after vNOTES: 0.8 versus 1.3 days, mean difference -0.5 days, (95% CI -0.98 to -0.02), P = 0.004. CONCLUSIONS: vNOTES is non-inferior to TLH for successfully performing hysterectomy without conversion. Compared with TLH, vNOTES may allow more women to be treated in a day-care setting. TWEETABLE ABSTRACT: RCT: vNOTES is just as good as laparoscopy for successful hysterectomy without conversion but allows more day-care surgery. ispartof: BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY vol:126 issue:1 pages:105-113 ispartof: location:England status: published

Study Objective We aimed to report an update of the systematic review and meta-analysis published in 2016, comparing hysterectomy by vaginal natural orifice transluminal endoscopic surgery (vNOTES) to the laparoscopic approach for benign indications. Design This was a systematic review and meta-analysis. We searched MEDLINE, EMBASE, CENTRAL and additional sources and aimed to retrieve randomised controlled trials (RCTs), controlled clinical trials (CCTs) and prospective/retrospective cohort studies in human subjects that allowed direct comparison of vNOTES to laparoscopy. Primary outcome was the proportion of women successfully treated with the intended approach to perform hysterectomy without conversion to any other technique. Setting N/A. Patients or Participants We included studies in the adult female population, undergoing removal of the uterus for benign gynecological disease. Studies on interventions for genital prolapse or gynecological malignancy were excluded. Interventions N/A. Measurements and Main Results Our search yielded one RCT and five retrospective cohort trials. Pooled analysis of two subgroups showed that, compared to conventional laparoscopy, vNOTES is equally effective to successfully remove the uterus in individuals meeting the inclusion criteria. vNOTES had significantly lower values for operation time, length of stay and estimated blood loss. There was no significant difference in intra-operative and post-operative complications, readmission, pain scores at 24 hours post-operative and change in haemoglobin on day 1 post-operative. Conclusion The available randomised and observational data show that vNOTES hysterectomy is an effective and safe novel technique for women eligible for endoscopic surgery.

This study aims to demonstrate the feasibility of a frugal approach to an endoscopic hysterectomy: the iHysterectomy. An iPhone with endoscope-i adaptor and a portable light source were used instead of a laparoscopic camera, video processor, monitor and light source. A vaginally assisted natural orifice transluminal endoscopic surgery (NOTES) hysterectomy (VANH) was performed by Poor Man9s NOTES technique using a self-constructed glove port and standard reusable instruments. Ten iHysterectomies were successfully performed by a single surgeon (JBa). No conversion to a laparoscopic tower, standard multi incision laparoscopy, or laparotomy was necessary. Mean operation time was 52 min (40–75); mean serum haemoglobin drop was 0.8 g/dL (0.2–2.1). There were no operative complications, and postoperative pain scores were low. The iHysterectomy technique enables surgeons to perform a minimally invasive hysterectomy in a low-resource setting without the need to invest in a laparoscopic tower. The investment required for endoscopic hardware is a fraction of that for conventional laparoscopy or robotic surgery. This is an Idea Development Exploration Assessment Long-term (IDEAL) stage 1 study: iHysterectomy is a novel approach requiring further validation. This is the first report on the use of an iPhone to perform a hysterectomy or any other major operation.

(1) Objective: We aimed to report an update of the systematic review and meta-analysis by Baekelandt et al. (2016). (2) Method: We followed PRISMA guidelines to perform this systematic review. We searched MEDLINE, EMBASE, CENTRAL and additional sources and aimed to retrieve randomised controlled trials (RCTs), controlled clinical trials (CCTs) and prospective/retrospective cohort studies in human subjects that allowed direct comparison of vNOTES to laparoscopy. (3) Results: Our search yielded one RCT and five retrospective cohort trials. Pooled analysis of two subgroups showed that, compared to conventional laparoscopy, vNOTES is equally effective to successfully remove the uterus in individuals meeting the inclusion criteria. vNOTES had significantly lower values for operation time, length of stay and estimated blood loss. There was no significant difference in intra- and postoperative complications, readmission, pain scores at 24 h postoperative and change in hemoglobin (Hb) on day 1 postoperative. ispartof: JOURNAL OF CLINICAL MEDICINE vol:9 issue:12 ispartof: location:Switzerland status: published

Study Objective Hysterectomy, is mostly performed by an abdominal approach and to a lesser extent by a vaginal access, which has been proven to result in superior patients’ outcomes. The Hominis Surgical System is a novel robot-assisted system, designed specifically for robotic vaginal natural orifice transluminal endoscopic surgery (RvNOTES). In the current study we aimed to present our experience in the first 30 RvNOTES hysterectomies, and to assess the feasibility and safety of this revolutionary technology Design A two-center prospective study of RvNOTES hysterectomy for benign indications. Setting N/A Patients or Participants Thirty women aged 38 to 79 years, BMI 18-40 kg/m2. Interventions RvNOTES hysterectomy. Measurements and Main Results Intraoperative and postoperative complications, median blood loss, duration of surgery and postoperative pain. All procedures were completed successfully without conversions to open surgery. No intraoperative complications were observed. Median blood loss and procedure duration were 50 ml (range: 20-400) and 41 minutes (range: 24 to 88), respectively. Postoperative pain was minimal with a median VAS of 3 (range: 1-5) The vaginal cuff was fully healed in all women at the 6-week post-operative follow up visit. Conclusion This is the first publication regarding a robotic-assisted vaginal hysterectomy. The combined advantages of the vNOTES approach with robotic instrumentation have the potential to shift the trend from abdominal to RvNOTES approach for a wide variety of gynecological and non-gynecological surgical procedures.

Study Objective Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) offers similar advantages of traditional vaginal surgery including no incisional pain as well as a better cosmetic outcome. Furthermore, vNOTES allows the surgeon to overcome the limited surgical space and lack of exposure when using the traditional vaginal instrumentation. Vaginal uterosacral ligament suspension subsequent to vaginal hysterectomy has the advantages of a mesh-free, minimally invasive approach for the treatment of pelvic organ prolapse. The objective of this video is to demonstrate a surgical technique and a few tips and tricks for vNOTES hysterectomy and uterosacral ligament suspension. Design Stepwise demonstration of the vNOTES technique for hysterectomy and vaginal apical suspension to the uterosacral ligament with narrated video footage. Setting An academic tertiary referral center. The ethics committee ruled that approval was not required for this study. Patients A 53-year-old woman. Interventions vNOTES hysterectomy and apical suspension to the uterosacral ligament. Measurements and Main Results A 53-year-old woman (gravida 5, para 4) presented with Pelvic Organ Prolapse Quantification System stage III symptomatic uterine prolapse. The patient was selected to be operated on via a vaginal port. The video presents some tips and tricks to aid the surgeon to perform this surgery in a safe and timely manner using the vaginal GelPOINT system (Applied Medical, Rancho Santa Margarita, CA). Conclusion vNOTES for repair of POP by uterosacral ligament suspension via a vaginal port is a feasible technique with promising cosmetic results. This technique allows the surgeon to expose the ureter well and lower the risk of ureteric injury. Additionally, this approach avoids mesh complications and should also decrease the risk of abdominal wound infection because of the absence of incisions on the abdomen.

Study Objective To assess whether sentinel node resection for endometrial cancer is feasible via retroperitoneal transvaginal natural orifice transluminal endoscopic surgery (vNOTES) and gives better exposure than transperitoneal vNOTES. Design This is a first small IDEAL (Idea Development Exploration Assessment Long-term follow up) stage 1 study to assess the feasibility of a new approach; the technique is explained step-by-step using videos (Video 1) and pictures. Setting The gynecologic oncology department of a nonuniversity teaching hospital in Belgium. Patients Since 2015, 15 patients were operated on via vNOTES for endometrial cancer [1] . Interventions Our initial experience showed that a transperitoneal approach via vNOTES [2] provided good access to the cranial pelvic retroperitoneum but not to the caudal pelvic retroperitoneum. Therefore, a new retroperitoneal vNOTES approach via a paracervical incision in the lateral vaginal fornix was developed. Via this incision, the obturator fossa is accessed, and a vNOTES port is placed for endoscopic dissection of the retroperitoneal space. This video article shows this new access route to the pelvic retroperitoneal space. Measurements and Main Results Our initial experience with vNOTES for endometrial cancer showed that transperitoneal access to the retroperitoneal space did not give optimal exposure to the caudal parts of the obturator space. The new retroperitoneal vNOTES approach shown in this video article gives better exposure to the entire retroperitoneal space including the caudal part of the obturator space; the sacral plexus; the external, internal, and common iliac arteries; and even the lower para-aortic region. Conclusion It has been previously shown that vNOTES hysterectomy offers patient benefits over total laparoscopic hysterectomy [3] . The retroperitoneal vNOTES approach now also offers good transvaginal access to the entire retroperitoneal space for sentinel node resection. This is a new approach that requires further validation before vNOTES hysterectomy with retroperitoneal sentinel node resection can be used outside study settings for the treatment of endometrial cancer.

The objective of this case report is to demonstrate a new hysterectomy technique via transvaginal natural orifice transluminal endoscopic surgery (NOTES) using robotic surgery. Previous experience with the Da Vinci Xi (Intuitive Surgery) for gynaecological oncology, and with NOTES for adnexal surgery and hysterectomy, led to the decision to combine the advantages of these techniques, namely to reduce the invasiveness of robotic surgery and improve the ergonomics of NOTES. A robotic vaginally assisted NOTES hysterectomy (VANH) was performed in five patients with a myomatous uterus. The circumcision of the cervix, the opening of the anterior and posterior peritoneum and the transection of both sacro-uterine ligaments were performed by classical vaginal surgery. A NOTES port was constructed by assembling a surgical glove, a wound protector, 4 Da Vinci 8-mm trocars and 1 reusable 5-mm trocar. The ring of the wound protector was then inserted transvaginally into the peritoneal cavity to create a pneumoperitoneum. The hysterectomy was performed via transvaginal NOTES using the surgical robot. Subsequently, a bilateral adnexectomy was performed in the same way. Once the hysterectomy and bilateral adnexectomy were completed, the robot and gloveport were removed. When the uterus was too large to extract in toto, it was manually morcellated so that it could be removed vaginally. The colpotomy was closed as in classical vaginal surgery. This is the first case report demonstrating that vaginal robotic surgery is possible and that it can be used to perform a hysterectomy. Robotic vaginally assisted NOTES hysterectomy (RVANH) makes use of the advantages of robotic surgery to broaden the indications for vaginal hysterectomy and can help overcome its limitations, while the NOTES approach avoids abdominal wall wounds and trocar-related complications. Further developments in robotic technology will help overcome the problem of robotic arm collision. Robotic hysterectomy via vaginal access is a novel approach that requires further validation. The extra cost and setup time of RVANH will also need to be assessed in comparison to the advantages it provides over a vaginally assisted NOTES hysterectomy or total laparoscopic hysterectomy.

The purpose of this study was to demonstrate the feasibility and safety of adnexectomy by transvaginal natural orifice transluminal endoscopic surgery (vNOTES) for benign adnexal masses. Conventional, reusable laparoscopic instruments were used, inserted through aninexpensive, self-constructed single port device. Between November 2013 and November 2014, 20 adnexectomies by vNOTES were performed by a single surgeon (BJ). Only conventional, reusable laparoscopic instruments were used. The self-constructed single port device was made by assembling a surgical glove, a wound protector, one reusable 10-mm trocar, and four reusable 5-mm trocars. The adnexectomy was performed according to the technique for standard laparoscopic surgery, and the specimen was removed through the colpotomy incision. Patient and perioperative data were analysed. Twenty patients underwent adnexectomy by vNOTES, and no conversion to standard laparoscopy or laparotomy was necessary. Mean operation time was 32 min (20–50 min); mean drop in hemoglobin level was 0.9 g/dl (0–2.1 g/dl). There were no operative complications. Post-operative pain scores were very low. The mean size of the removed adnexal mass was 51.8 mm (35–110 mm). Adnexectomy by vNOTES is feasible even for masses up to 110 mm and even when performed with reusable, conventional laparoscopic instruments. The main advantages of vNOTES are better cosmetics, low postoperative pain scores and easy removal of the specimen without spillage. This frugally innovative technique also enables surgeons to perform adnexectomies by vNOTES in low resource settings.

The purpose of this study was to demonstrate the feasibility and safety of total laparoscopic hysterectomy (TLH) by single-incision laparoscopic surgery (SILS) with conventional, reusable laparoscopic instruments, inserted through an inexpensive, self-constructed single-port device. Between June 2013 and April 2014, 15 TLHs by SILS were performed by a single surgeon (BJ). Only conventional, reusable laparoscopic instruments were used. The self-constructed single-port device was made by assembling a surgical glove, a wound protector, one reusable 10-mm trocar, and four reusable 5-mm trocars. The vaginal cuff was closed by intracorporeal suturing. Patient and perioperative data were analysed. Fifteen patients underwent TLH by SILS, and no conversion to standard laparoscopy or laparotomy was necessary. Mean operation time was 97 min (55–135 min), and mean drop in haemoglobin level was 1.2 g/dl (0–2.4 g/dl). There were no operative complications. Postoperative pain scores were low. The mean weight of the removed uterus was 118 g (50–208 g). TLH by SILS is feasible even when performed with reusable, conventional laparoscopic instruments. An inexpensive, self-constructed single-port device allows every surgeon worldwide to accomplish single-incision surgery without the need to invest in expensive ports, disposable instruments, sealing devices, or auto-locking sutures.

Objective To demonstrate a new approach for performing an ovarian cystectomy via transvaginal natural orifice transluminal endoscopic surgery (vNOTES) as an alternative for a laparoscopic ovarian cystectomy. Design Stepwise explanation of the technique using original video footage. Setting Hospital. Patient(s) Fourteen patients who provided informed consent and were treated transvaginally to remove a benign ovarian cyst. Intervention(s) The patient was placed in the lithotomy position under general anaesthesia. A 2.5-cm posterior colpotomy was made. The pouch of Douglas was opened and a transvaginal natural orifice transluminal endoscopic surgery (vNOTES) port was inserted transvaginally. A pneumoperitoneum was created, and the ovarian cyst was identified. Conventional endoscopic instruments and a standard endoscope were inserted transvaginally through the vNOTES port. The ovarian cortex was incised over the cyst using cold scissors. The cyst was dissected from the ovarian cortex by a combination of blunt and sharp dissection. Ovarian hemostasis was achieved using bipolar forceps. The ovarian cyst was removed through the colpotomy in an endobag. The vNOTES port was removed, and the colpotomy was sutured using a resorbable suture. The following data were collected: age, body mass index, parity, number of previous abdominal procedures, ovarian cyst diameter, operating time, length of hospital stay, and visual analog scale score. Main Outcome Measure(s) Successful minimally invasive ovarian cystectomy via vNOTES without abdominal scars. Result(s) An ovarian cystectomy was successfully completed in all patients without conversions to standard laparoscopy, and no complications occurred. A fertility sparing cystectomy was performed via vNOTES in all patients; no ovariectomies were performed. All patients were discharged within 30 hours, and nine patients were discharged within 12 hours. Benign ovarian cysts can be treated by vNOTES through a posterior colpotomy via the pouch of Douglas. In a low-resource setting, a self-constructed gloveport and standard reusable endoscopic instruments can be used. In a first-world setting the surgical time can be reduced using a commercially available vNOTES port. Conclusion(s) Transvaginal natural orifice transluminal endoscopic surgery provides a new, less invasive approach for performing an ovarian cystectomy. This first IDEAL (idea, development, exploration, assessment, long-term study) stage 1 study confirms the feasibility of vNOTES ovarian cystectomy although it remains a novel approach that requires further investigation. It can provide improved patient comfort and better cosmetic results.

Objective To demonstrate a new approach for performing a myomectomy via transvaginal natural-orifice transluminal endoscopic surgery (vNOTES) as an alternative to laparoscopic myomectomy. Design Stepwise explanation of the technique with the use of original video footage. Setting Hospital. Patient(s) Eight patients were treated transvaginally for intramural, subserosal, and pedunculated myomas. Intervention(s) In case of a posterior myoma, a 2.5-cm posterior colpotomy was made under general anesthesia. The pouch of Douglas was opened and a vNOTES port was inserted transvaginally. In case of an anterior myoma, an anterior colpotomy was made and the peritoneum was opened between the uterus and the bladder. A vNOTES port was inserted transvaginally. A pneumoperitoneum was created and the myoma was identified. With the use of conventional endoscopic instruments and a standard endoscope, all inserted through the vNOTES port, the uterine serosa was incised over the myoma and the myoma was resected. After achieving hemostasis the uterine scar was sutured in two layers with the use of a standard absorbable suture or an autolocking suture. An adhesion-preventing barrier was applied over the uterine scar. The myoma was removed through the colpotomy in an endobag. The vNOTES port was removed and the colpotomy was sutured with the use of an absorbable suture. The following data were collected: age, body mass index, number of previous abdominal procedures, myoma size, myoma weight, operating time, length of hospital stay, visual analog scale pain score, and serum hemoglobin drop. Main Outcome Measure(s) Successful minimally invasive myomectomy via vNOTES without abdominal scars. Result(s) All fibroids were successfully removed via vNOTES without complications or conversions to standard laparoscopy. No peri- or postoperative complications occurred. All patients were discharged within 24 hours, two of them within 12 hours. Anterior myomas can be resected through an anterior colpotomy and posterior myomas can be resected through a posterior colpotomy via the pouch of Douglas. In a low-resource setting, a self-constructed gloveport can be used and the uterine scar can be sutured via vNOTES with the use of a standard absorbable suture. In a first-world setting, the surgical time can be reduced with the use of an autolocking suture and a commercially available vNOTES port. Conclusion(s) Myoma types 0–2 can be resected hysteroscopically. Myoma types 3–7 are traditionally resected via laparotomy, laparoscopy, or transabdominal robotic surgery. vNOTES provides a new less invasive approach for the resection of myoma types 3–7. This first IDEAL stage 1 study confirms the feasibility of vNOTES myomectomy. It remains, however, a novel approach that requires further investigation. It can provide better cosmetic results and improved patient comfort.

Study Objective The objective of this study is to describe our experience with Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) utero-sacral ligament apical suspension and to evaluate the learning curve of mastering the skills to operate this procedure. Design A retrospective multicenter study of the first 30 vNOTES hysterectomy and USLS surgeries performed between October 2018 and April 2019 at Rambam Health Care Campus (Israel) by a single surgeon (L.L) and Imelda Hospital (Belgium) by (J.B). Setting Retrospective study Patients or Participants Women who underwent sutero-sacral ligament suspension for treatment of uterovaginal or vaginal apical prolapse Interventions Vaginal hysterectomy and utero-sacral ligament suspension Measurements and Main Results The primary outcomes were hysterectomy and USLS times. Secondary outcomes included intra-operative bleeding, length of hospitalization, post-operative pain and need for analgesia. Sociodemographic and clinical data were retrieved from patients’ electronic charts. Patients` median age was 55 years (range 40-81); Median hysterectomy time was 38 minutes (range 15-55) from first cut to completion of hysterectomy; Median USLS time was 17 minutes (range 14-27). The median estimated intra-operative blood loss was 20 ml (range 20-250). Length of hospital stay was 2 days (2-3). Comparisons between median USLS time in the first 15 and in the 15 sequential procedures demonstrated a significant decrease: 25 minutes (range 18-39) vs. 15 minutes (range 13-28) respectively (P=0.03). The median estimated intraoperative blood loss decreased from 70 ml (range 40-100) in the first 15 suspensions to 20 ml (range 10-70) in the 15 sequential procedures (P=0.011) Conclusion vNOTES hysterectomy followed by USLS is a feasible procedure with an marked improvement in surgical performance in a short period as expressed by the improvement in surgical times with minor associated perioperative complications. This technique allows surgeon to expose the ureter well and lower the risk of ureter injury. Outcomes of long-term follow-up should be investigated.

Study Objective The vaginal approach is considered safer than umbilical access in gynecological surgeries. However, despite the growing popularity of robotic surgery, it has not been performed through the vagina. We set out to evaluate the feasibility of vaginal access in robotic surgery. Here we present a case series of the revolutionary technology of robotic vaginal natural orifice transluminal endoscopic surgery (vNOTES), using the Hominis system, on vaginal hysterectomy. Design This is a prospective analysis of hysterectomy performed by robotic vNOTES. 10 women with nonmalignant indications were recruited. Setting Prospective study. Patients or Participants 10 women with nonmalignant indications for hysterectomy were recruited. Interventions Hysterectomy. Measurements and Main Results Two robotic arms were inserted through the posterior fornix. Each arm has built-in mono- and bi-polar capabilities, their actions are controlled by the surgeon sitting at the console a few feet away. Surgical data were collected during the procedures. The median age was 60 years [range: 43-73]; the median BMI was 26 [range: 17-33], the median total operative time was 60 minutes [range: 24-88]. decreasing duration over time indicated a fast learning curve. There were no intraoperative and postoperative adverse events. Conclusion This is the first documentation of a robotic hysterectomy performed via the vagina. Outstanding features of vNOTES include its portability and easy handling due to its light weight (less than 10 pounds), scarless surgery, and access to any part of the abdomen by articulation of the flexible robotic arms. No special maintenance is required. The approach combines the benefits of vaginal procedures and laparoscopic techniques and maintains safety in regard to proximity to pelvic organs. This case series demonstrates the feasibility of using vNOTES for hysterectomy for benign gynecologic indications

Objective To critically appraise studies comparing benefits and harms in women with benign disease without prolapse undergoing hysterectomy by natural orifice transluminal endoscopic surgery (NOTES) versus laparoscopy. Study design We followed the PRISMA guidelines. We searched MEDLINE, EMBASE and CENTRAL for randomised controlled trials (RCTs), controlled clinical trials (CCTs) and cohort studies comparing NOTES with laparoscopy assisted vaginal hysterectomy (LAVH) or total laparoscopic hysterectomy (TLH) in women bound to undergo removal of a non-prolapsed uterus for benign disease. Two authors searched and selected studies, extracted data and assessed the risk of bias independently. Any disagreement was resolved by discussion or arbitration. Results We did not find RCTs but retrieved two retrospective cohort studies comparing NOTES with LAVH. The study quality as assessed by the Newcastle–Ottawa scale was acceptable. Both studies reported no conversions. The operative time in women treated by NOTES was shorter compared to LAVH: the mean difference (MD) was −22.04 min (95% CI −28.00 min to −16.08 min; 342 women; 2 studies). There were no differences for complications in women treated by NOTES compared to LAVH: the risk ratio (RR) was 0.57 (95% CI 0.17–1.91; 342 women; 2 studies). The length of stay was shorter in women treated by NOTES versus LAVH: the MD was −0.42 days (95% CI −0.59 days to −0.25 days; 342 women; 2 studies). There were no differences for the median VAS scores at 12 h between women treated by NOTES (median 2, range 0–6) or by LAVH (median 2, range 0–6) (48 women, 1 study). There were no differences in the median additional analgesic dose request in women treated by NOTES (median 0, range 0–6) or by LAVH (median 1, range 0–5) (48 women, 1 study). The hospital charges for treatment by NOTES were higher compared to LAVH: the mean difference was 137.00 € (95% CI 88.95–185.05 €; 294 women; 1 study). Conclusions At the present NOTES should be considered as a technique under evaluation for use in gynaecological surgery. RCTs are needed to demonstrate its effectiveness.

OBJECTIVE: To present different aspects and advantages of the laparoscopic approach to the pelvic nerves aimed at treating intractable pelvic neuralgia. METHODS: We report on a nonconsecutive series of 7 patients with different types and etiologies of chronic pelvic neuralgia, all of whom underwent laparoscopy. In all 7 cases, the neuralgia was refractory to medical management and had profound socioeconomic consequences for the patients. RESULTS: Techniques of laparoscopic transperitoneal neurolysis of several pelvic somatic nerves are described but also our technique of laparoscopic implantation of neuroprothesis for neuromodulation on somatic pelvic nerves or on autonomic pelvic nerves as the superior hypogastric plexus. DISCUSSION: Laparoscopic approach to the pelvic nerves opens new possibilities for the diagnosis and treatment of pelvic neuralgia, and offers new curative surgical techniques. © 2007 Lippincott Williams & Wilkins, Inc.

The aim of this study was to demonstrate the feasibility of a total hysterectomy performed entirely by transvaginal natural orifice transluminal endoscopic surgery (vNOTES). Conventional, reusable laparoscopic instruments were used, inserted through an inexpensive, self-constructed single-port device. Ten total vaginal NOTES hysterectomies (TVNHs) were performed by a single surgeon. The self-constructed single-port device was made by assembling a surgical glove, a wound protector or modified laryngeal mask airway, 1 reusable 10-mm trocar, and 4 reusable 5-mm trocars. This gloveport was inserted into the vagina to create a pneumovagina. The conventional steps of a vaginal hysterectomy were followed, but performed endoscopically with standard reusable endoscopic instruments. The patient and perioperative data were analyzed. No conversion to standard laparoscopy or laparotomy was necessary in any of the 10 patients who underwent a TVNH. Mean operation time was 97 min (range: 60-120); mean drop in hemoglobin level was 1.5 g/dL (range: 0.5-2.4). There were no operative complications, and postoperative pain scores were very low. This first report on a small number of patients demonstrates that TVNH is possible. By incorporating the advantages of endoscopic surgery, TVNH broadens the indications for vaginal hysterectomy and helps overcome its limitations. At the same time, the NOTES approach avoids abdominal wall wounds and trocar-related complications. TVNH is feasible, even when performed with reusable, conventional laparoscopic instruments. This frugally innovative technique also enables surgeons to perform hysterectomies by vNOTES in low resource settings.

Objective To demonstrate a new minimally invasive approach for the diagnosis and treatment of ectopic pregnancy. Design Stepwise explanation of the technique using original video footage. Setting Hospital. Patient(s) Since 2014, 15 patients were treated transvaginally for ectopic pregnancy and pregnancy of unknown location (PUL). Intervention(s) In case of a diagnosis of ectopic pregnancy on ultrasound, a 2.5-cm colpotomy is made under general anesthesia, and the ectopic pregnancy is treated by transvaginal natural orifice transluminal endoscopic surgery (vNOTES) salpingectomy or salpingostomy. In case of a PUL on ultrasound, transvaginal hydrolaparoscopy (TVHL), an established technique for fertility exploration under local or general anesthesia, is used to investigate. If a tubal pregnancy is confirmed on TVHL, the colpotomy is extended to a 2.5-cm incision, and the ectopic pregnancy is treated transvaginally by vNOTES. If the TVHL investigation of the pelvis is negative (fallopian tubes and ovaries are normal), the procedure is stopped and the patient is followed up further. If the TVHL is inconclusive, the NaCl is drained and CO 2 is insufflated (requiring general anesthesia) through the 4-mm TVHL port to improve visualization. Again, an ectopic pregnancy is then treated by vNOTES, and in case of a negative investigation the procedure is stopped and the patient is followed up further. Main Outcome Measure(s) Successful diagnosis and treatment of ectopic pregnancies. Result(s) All patients were successfully operated without complications or conversions to standard laparoscopy. Twelve patients were treated by vNOTES for ectopic pregnancy. Three TVHL explorations for PUL were negative, and these patients were followed up; two patients developed a normal intrauterine pregnancy, and the third patient was treated with methotrexate for persistent asymptomatic raised hCG levels. Conclusion(s) Transvaginal hydrolaparoscopy and vNOTES are complementary techniques enabling gynecologic surgeons to explore PUL and treat ectopic pregnancies via minimally invasive transvaginal access without abdominal incisions. A negative TVHL investigation leaves only a 4-mm perforation in the pouch of Douglas that does not require suturing. The IMELDA technique for the investigation and treatment of PUL and ectopic pregnancy is a novel approach that requires further investigation. It can provide improved patient comfort and better cosmetic results.

IntroductionNatural orifice transluminal endoscopic surgery (NOTES) uses natural orifices to access the cavities of the human body to perform surgical interventions. NOTES limits the magnitude of surgical trauma and potentially reduces postoperative pain. Our group published a protocol on a randomised study comparing transvaginal NOTES (vNOTES) versus laparoscopy for hysterectomy (HALON). We simultaneously designed a similar randomised controlled trial (RCT) comparing vNOTES with laparoscopy for adnexectomy. To the best of our knowledge, this is the first RCT comparing vNOTES with laparoscopy for adnexal surgery.Methods and analysisThe methodology of the Notes Adnexectomy for Benign Indication versus Laparoscopic Excision (NOTABLE) study is similar to that of the HALON trial. Women aged 18–70 years with an indication for benign adnexal surgery will be eligible. We will use stratification according to adnexal size. Entrants will be randomised to the laparoscopic treatment (control) or vNOTES (intervention). Participants will be evaluated on days 0–7 and at 3 and 6 months. The primary outcome will be the proportion of women successfully treated by removing an adnexa by the allocated technique without conversion. We will collect the following data (secondary outcomes): proportion of women hospitalised on the day of surgery, postoperative pain scores measured two times per day from day 1 to 7, total dosage of pain killers used from day 1 to 7, hospital readmission during the first 6 weeks, dyspareunia and sexual well-being at baseline, 3 and 6 months using a validated questionnaire (Short Sexual Functioning Scale), health-related quality of life at baseline, 3 and 6 months after surgery using a validated questionnaire (EQ-5D-3L), duration of surgical intervention, infection or other surgical complications and direct costs up to 6 weeks following surgery. For the primary outcome measure, a one-sided 95% CI of the difference in the proportions of women with a successful removal of the uterus by the randomised technique will be estimated. Non-inferiority will be concluded when 15% lies above the upper limit of this 95% CI.Ethics and disseminationThe study was approved on 1 December 2015 by the EthicsCommitteeof the Imelda Hospital (registration no: 689), Bonheiden, Belgium. We aim to present the final results of the NOTABLE trial in peer-reviewed journals and at scientific meetings within 4 years after the start of the recruitment.Trial registration numberNCT02630329.

Study Objective To show that in selected cases transvaginal NOTES can be a frugally innovative approach for adhesiolysis and that it can be performed in a low-cost setting. Design Step-by-step explanation of the technique using videos and pictures (educative video). Patients and Measurements A 51-year old (para 2, gravida 2) presented with meso- and hypogastric pain. Two years before, an umbilical hernia had been repaired using a Proceed Ventral Patch mesh. The diagnosis of pain caused by adhesions was made, and laparoscopic adhesiolysis was planned. On ultrasound, a small left ovarian fibroma was visualized. Because of the suspected umbilical location of the adhesions, we decided to use a transvaginal NOTES approach to perform adhesiolysis and left adnexectomy. Pathological examination confirmed a small benign papillary serous adenofibroma of the ovary. Interventions A transvaginal NOTES approach to perform adhesiolysis combined with left adnexectomy using only standard reusable laparoscopic instruments and a low-cost self-constructed NOTES port. Main Results The procedure and postoperative recovery were uneventful. No minor or major complications occurred. The patient has been cured of her pain. Conclusion Transvaginal NOTES is a novel approach that requires further validation. This case report shows that transvaginal NOTES can be used to perform adhesiolysis for abdominal pain and that it can be performed in a low-cost setting without the need for expensive ports or disposable instruments.