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Safety and efficacy of a self-developed Chinese pelvic repair system and Avaulta repair system for the treatment of pelvic organ prolapse in women
Safety and efficacy of a self-developed Chinese pelvic repair system and Avaulta repair system for the treatment of pelvic organ prolapse in women
- Source :
- Medicine
- Publication Year :
- 2020
- Publisher :
- Lippincott Williams & Wilkins, 2020.
-
Abstract
- Supplemental Digital Content is available in the text<br />The pelvic organ prolapse (POP) repair systems used in China are imported and expensive. Our aim was to compare the efficacy and safety of a self-developed pelvic floor repair system versus the Avaulta system. This was a multicenter, randomized, parallel-group, noninferiority trial of 132 patients with POP stage ≥II from the Tongji Hospital Affiliated to Tongji University and the General Hospital of Ningxia Medical University enrolled from 02/2014 to 03/2015. The patients were randomized 1:1 to POP repair using the self-developed system or the Avaulta system. Perioperative conditions, POP quantification, pelvic floor impact questionnaire-7, and prolapse quality of life questionnaires, gynecological ultrasound, and postoperative complications were compared. Patients were followed at 1.5, 3, and 6 months. According to the POP quantification scores obtained at 6 months after surgery, the cure rates of the self-developed and Avaulta groups were 98.3% and 100.0%, respectively (P > .999). At 6 months follow-up, the pelvic floor impact questionnaire-7 scores of the self-developed and Avaulta groups were both improved (P .05). There were no significant differences between the 2 groups regarding complications (all P > .05). The self-developed pelvic reconstruction system is safe and effective for the treatment of POP and improves the patients’ quality of life, without difference compared to the Avaulta system.
- Subjects :
- medicine.medical_specialty
China
Observational Study
pelvic reconstruction
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
Quality of life
Double-Blind Method
law
Surveys and Questionnaires
Medicine
Humans
030212 general & internal medicine
Stage (cooking)
Aged
Pelvic organ
Pelvic floor
Group study
business.industry
pelvic floor functional recovery
General Medicine
Perioperative
Middle Aged
Plastic Surgery Procedures
Surgical Mesh
pelvic organ prolapse
Surgery
body regions
medicine.anatomical_structure
Surgical mesh
Treatment Outcome
mesh
quality of life
030220 oncology & carcinogenesis
ComputingMethodologies_DOCUMENTANDTEXTPROCESSING
Female
business
Research Article
prospective study
Subjects
Details
- Language :
- English
- ISSN :
- 15365964 and 00257974
- Volume :
- 99
- Issue :
- 38
- Database :
- OpenAIRE
- Journal :
- Medicine
- Accession number :
- edsair.doi.dedup.....a0462d51cd415e762398d26aa3db98cb