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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Apical Prolapse

Treatments: Procedure: native tissue repair procedures with conventional surgical instruments

Study type: Interventional

Funder types: Other

Identifiers

NCT04213027

PekingUMCH SSLFvsISFF-CSI

Details and patient eligibility

About

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).

Full 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.

Enrollment: 320 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups

SSLF-CSI

Active Comparator group

Description:

native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients randomized to Sacrospinous ligament fixation (SSLF) .

Treatment:

Procedure: native tissue repair procedures with conventional surgical instruments

ISFF-CSI

Active Comparator group

Description:

native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients randomized to Ischial spinous fascia fixation (ISFF)

Treatment:

Procedure: native tissue repair procedures with conventional surgical instruments