NCT04213027

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

Sacrospinous Ligament Fixation vs. Ischial Spine Fasicia Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients: a Multi-center, Prospective, Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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).

Detailed description

The population will include Chinese female patients with advanced apical prolapse (stage II-III) and who are undergoing Sacrospinous Ligament Fixation (SSLF) and Ischial spinous fascia fixation (ISFF) procedure using conventional surgical instruments without special instrument. After enrollment, standardized baseline data including demographics, POPQ evaluation, series of validated questionaires via interviews( PFDI-20, PFIQ-7, PISQ-12) will be collected by study personnel at the baseline visit. Eligible consenting patients will proceed to randomizations with equal probability of assignment to SSLF or ISFF. Randomization to either SSLF or ISFF will take place preoperatively by each clinical site using a random permutated block design. After index surgical intervention, scheduled follow-up will occur at 3, 6, 12, 24 and 36 months after the index surgery. At the follow-up visits, POPQ examination will be performed and an update of current medications, an assessment of new or continuing pelvic floor disorders, adverse events that occurred since the previous evaluation, and an assessment of health care costs. A series of validated instruments will be administered via interviews to including PFDI-20, PFIQ-7, PISQ-12, PGI-C.

Conditions

• Apical Prolapse

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-12-31
• Completion: 2025-12-31
• First posted: 2019-12-30
• Last updated: 2020-01-02

Locations

5 sites across 1 country: China