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

Not Applicable

Recruiting

• Conditions: Apical Prolapse
• Interventions: Procedure: native tissue repair procedures with conventional surgical instruments

• Registration Number: NCT04213027
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-25
• Study First Submitted QC: 2019-12-25
• Last Update Submitted: 2019-12-27
• Study First Posted: 2019-12-30
• Study Start: 2020-01-01
• Last Update Posted: 2020-01-02
• Primary Completion: 2022-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 320

Inclusion Criteria

1. Women with apical prolapse with POP-Q II-IV (but no anterior wall prolapse stage IV)
2. SSLF or ISFF is proceeded as described before，while ancillary procedures like vaginal hysterectomy, anterior/posterior vaginal wall repair without mesh or mid-urethral suspension could be performed simultaneously.
3. Women who have been eligible for long-term follow-up.
4. Women who agreed to participate in the study and signed informed consent.

Exclusion Criteria

1. Women who have surgical history for prolapse with mesh.
2. Women who have contraindication for surgical procedure
3. Women who are unable to comply with the study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ISFF-CSI	native tissue repair procedures with conventional surgical instruments	native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients randomized to Ischial spinous fascia fixation (ISFF)
SSLF-CSI	native tissue repair procedures with conventional surgical instruments	native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients randomized to Sacrospinous ligament fixation (SSLF) .

Primary Outcome Measures

Name	Time	Method
rate of surgical success	up to 36 months after operation	definition for surgical success is symptomatic prolapse below grade II occurred at 3 months after operation, and the severest indication point in POP-Q evaluation was taken as the criterion. No vaginal swelling sensation, that is answer "no" for PFDI-20 Questionnaire Question 3, "Do you often see or feel vaginal tumors come out?".; The patient's self-perception symptoms is improved or improved significantly, that is answer 1 or 2 for the PGI-C questionnaire.; There is no need of further treatment for prolapse, such as reoperation or pessary.

Secondary Outcome Measures

Name	Time	Method
rate of Postoperative recurrence	from 3 months after operation up to 36 months after operation	definition for postoperative recurrence is symptomatic prolapse above grade II occurred 3 months after operation, and the severest indication point in POP-Q evaluation was taken as the criterion. Vaginal swelling sensation, that is answer "yes" for PFDI-20 Questionnaire Question 3, "Do you often see or feel vaginal tumors come out?".; There is need of further treatment for prolapse, such as reoperation or pessary.
visual analogue scales	up to 36 months after operation, usuallly within 3 days after operation	postoperative pain evaluation esp. hip pain by visual analogue scales (VAS). Visual Analogue Scale (VAS) is a self-report measure consisting simply of a 10 centimeter line with a statement at each end representing one extreme of the dimension being measured (most often intensity of pain). VAS result will be reported ranging from 0 to 10, with 0 representing no pain, and 10 representing unbearable severe pain
changes between preoperative and postoperative symptomatic improvement using validated instruments(PFIQ-7)	up to 36 months after operation	Relief of symptoms using validated instruments, pelvic floor impact questionnaire short form 7(PFIQ-7)。PFIQ-7 scores 0-300, the higher the severer negative influence on patient.
changes between preoperative and postoperative symptomatic improvement using validated instruments(PFDI-20)	up to 36 months after operation	Relief of symptoms using validated instruments, pelvic floor distress inventory short form 20(PFDI-20), PFDI-20 scores 0-300, the higher the severer negative influence on patient.
changes between preoperative and postoperative symptomatic improvement using validated instruments(PISQ-12)	up to 36 months after operation	Relief of symptoms using validated instruments, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form(PISQ-12), PISQ-12 scores 0-48, the higher, the severer negative influence on patient.
results of postoperative symptomatic improvement using patient global impression of change (PGI-C)	up to 36 months after operation	Relief of symptoms using patient global impression of change (PGI-C)， PGI-C scores 1-7, the higher, the the severer negative influence on patient.
intraoperative and post operative complications	up to 36 months after operation	using IUGA/ICS joint terminology CTS coding system and dingo system

Trial Locations

Locations (5)

2nd Affiliated hospital of Anhui Medical college; 🇨🇳 Hefei, Anhui, China

1st Affiliated hospital of PLA general hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Suzhou City Hospital; 🇨🇳 Suzhou, Jiangsu, China

Shanghai First Maternity and Infant Hospital; 🇨🇳 Shanghai, Shanghai, China