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Clinical Trial Summary

A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.


Clinical Trial Description

Investigational intervention:SSLF or ISFF operations

Study title:A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.

Principal Investigator:Chang Ren, M.D., Department of Obstetrics & Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.

Study subjects:Adult patients with symptomatic stage II~IV pelvic organ prolapse will be eligible if all the inclusion criteria are met and without any reason for exclusion.

Study objectives:The primary objective of this study is to assess the short and mid-term efficacy of Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation in treating stage II~ IV pelvic organ prolapse and their recurrence rate as well as their impacts on quality of life.

Study design:Prospective, Single-Blind, Randomized, Clinical Trial

Intervention:

- ISFF group:Patients receive ISFF according to randomization.

- SSLF group:Patients receive SSLF according to randomization

Sample size:76 patients (38 in ISFF group, 38 in SSLF group)

Primary endpoint:

•objective success rates at 3 months after operations.

Secondary endpoints:

- peri-operative parameters .

- subjective satisfactory rates at 1 year after operations

- quality of life questionnaires at 1 year after operations

Safety endpoints: complications ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03005613
Study type Interventional
Source Peking Union Medical College Hospital
Contact Chang Ren, M.D.
Phone +86-134-886-988-61
Email [email protected]
Status Recruiting
Phase N/A
Start date January 2017
Completion date December 2020

See also
  Status Clinical Trial Phase
Completed NCT04980196 - Is Preoperative Urodynamics Essential for Women With Pelvic Organ Prolapse
Recruiting NCT03766048 - LAparoscopic Preventive PRErectal Mesh N/A
Active, not recruiting NCT02431897 - Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen Phase 4