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Short-term Outcomes of Single-port Versus Multiport Laparoscopic Surgery for Colon Cancer: The SIMPLE Multicenter Randomized Clinical Trial
- Source :
- Annals of surgery. 273(2)
- Publication Year :
- 2020
-
Abstract
- OBJECTIVE To compare short-term perioperative outcomes of single-port laparoscopic surgery (SPLS) and multiport laparoscopic surgery (MPLS) for colon cancer. SUMMARY BACKGROUND DATA Although many studies reported short- and long-term outcomes of SPLS for colon cancer compared with MPLS, few have reported results of randomized controlled trials. METHODS This was a multicenter, prospective, randomized controlled trial with a noninferiority design. It was conducted between August 2011 and June 2017 at 7 sites in Korea. A total of 388 adults (aged 19-85 yrs) with clinical stage I, II, or III adenocarcinoma of the ascending or sigmoid colon were enrolled and randomized. The primary endpoint was 30-day postoperative complication rates. Secondary endpoints were the number of harvested lymph nodes, length of the resection margin, postoperative pain, and time to functional recovery (bowel movement and diet). Patients were followed for 30 days after surgery. RESULTS Among 388 patients, 359 (92.5%) completed the study (SPLS, n = 179; MPLS, n = 180). The 30-day postoperative complication rate was 10.6% in the SPLS group and 13.9% in the MPLS group (95% confidence interval, -10.05 to 3.05 percentage points; P < 0.0001). Total incision length was shorter in the SPLS group than in the MPLS group (4.6 cm vs 7.2 cm, P < 0.001), whereas the length of the specimen extraction site did not differ (4.4 cm vs 4.6 cm, P = 0.249). There were no significant differences between groups for all secondary endpoints and all other outcomes. CONCLUSIONS Even though there was no obvious benefit to SPLS over MPLS when performing colectomy for cancer, our data suggest that SPLS is noninferior to MPLS and can be considered an option in selected patients, when performed by experienced surgeons.Trial registration: ClinicalTrials.gov Identifier: NCT01480128.
- Subjects :
- Laparoscopic surgery
Adult
Male
medicine.medical_specialty
Time Factors
medicine.medical_treatment
Adenocarcinoma
law.invention
03 medical and health sciences
Young Adult
0302 clinical medicine
Postoperative Complications
Randomized controlled trial
law
Republic of Korea
Clinical endpoint
Medicine
Humans
Prospective Studies
Colectomy
Aged
Aged, 80 and over
business.industry
Postoperative complication
Sigmoid colon
Perioperative
Middle Aged
Surgery
medicine.anatomical_structure
Treatment Outcome
030220 oncology & carcinogenesis
Colonic Neoplasms
Resection margin
030211 gastroenterology & hepatology
Female
Laparoscopy
business
Subjects
Details
- ISSN :
- 15281140
- Volume :
- 273
- Issue :
- 2
- Database :
- OpenAIRE
- Journal :
- Annals of surgery
- Accession number :
- edsair.doi.dedup.....6bf49b92f60db7e355a705e28c3a6ce8