RCT for SSLF vs. ISFF With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients

Summary

This trial is designed to investigate the efficacy and safety of two native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients (POP-Q II-IV) and compare the outcome in prolapse women randomized to Sacrospinous ligament fixation (SSLF) and Ischial spinous fascia fixation (ISFF).

Conditions

• Apical Prolapse

Interventions

PROCEDURE

native tissue repair procedures with conventional surgical instruments

Sacrospinous ligament fixation (SSLF): treatment for apical prolapse with vaginal fornix suspended to sacrospinous ligament; Ischial spinous fascia fixation (ISFF): treatment for apical prolapse with vaginal fornix suspended to ischial spinous fascia (ISFF).

Sponsors & Collaborators

• Peking Union Medical College Hospital

  lead OTHER

Principal Investigators

• Yongxian Lu · 1st Affiliated hospital of PLA general hospital

• Zhiyuan Dai · Shanghai First Maternity and Infant Hospital

• Wenyan Wang · 2nd Affiliated hospital of Anhui Medical college

• Zhaoai Li · Shan'xi Province Women's and Children's Hospital

• Yuling Wang · Foshan Women's and Children's Hospital

• Shunyu Hou · Suzhou City Hospital

• Xiangjuan Li · Hangzhou Women's and Children's Hospital

• Lubin Liu · Chongqing Women's and Children's Hospital

• Le Ma · Beijing Obstetrics and Gynecology Hospital

• Tao Xu · Statistics Department of Peking Union Medical College

• Joseph Schaffer · UT Southwestern Medical Center

• Marko J Jachtorowycz · Saint Francis Hospital

• Lan Zhu · Peking Union Medical College Hospital

• Yuxin Dai · Peking Union Medical College Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-01

Primary Completion

2022-12-31

Completion

2025-12-31

Countries

• China

Study Locations