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The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions

Gynecologic Surgery Clinical Trial

Official title:
The Assessment of the Use of Anti-Adhesion Agents to Prevent Pelvic Postoperative Adhesions

Clinical Trial Summary

The aim of this study is to assess the safety and effectiveness of PROTAHERE Absorbable Adhesion Barrier to prevent pelvic postoperative adhesions.

Clinical Trial Description

The study is a random, evaluator-blinded, controlled, single center clinical trial. Recruiting patients who are premenopausal and scheduled for pelvic surgery including myomectomy, pelvic adhenolysis, endometriosis surgery, salpingostomy, dermoid cyst removal, ovarian cystectomy or any pelvic surgery other than total metrectomy. Patients recruited are randomly divided into five groups, PROTAHERE, Hyalobarrier, Seprafilm, Interceed or no treatment when the inclusion criteria are met and the inform consents are obtained. They are followed for 24 months including visits at 14 days, 3, 6, 12, 18, 24 months post-operation for the safety and effectiveness evaluation. The primary endpoints are the incidence of adhesions at 3-month as well as the incidence of any adverse events during the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04063085
Study type Interventional
Source SciVision Biotech Inc.
Contact
Status Completed
Phase N/A
Start date April 25, 2018
Completion date October 12, 2023
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