Sacrospinous Ligament Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients (SSLF-CSI)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: sacrospinous Ligament Fixation

Study type: Observational

Funder types: Other

Identifiers

NCT03782285

PekingUnion：SSLF-CSI

Details and patient eligibility

About

SSLF is typically a suture-based attachment of the vaginal apex to the sacrospinous ligament, either unilaterally or bilaterally. It is usually accomplished with specially designed equipment in English-language scientific literature. However, these instruments either reusable or disposable are relatively expensive and difficult in accessibility, and are not yet widely applied around China. Typical Asian smaller pelvis offers us an optional repair procedure with conventional surgical instruments instead of special instrument.

Full description

Apical prolapse is defined as descent of the uterus and cervix, the cervix alone, or the post-hysterectomy vaginal cuff down to the hymen, lower vagina, or past the introitus. Among 684,250 POP procedures that were performed in 15 Organization for Economic Co-operation and Development (OECD) countries in 2012, apical compartment repairs represented 20% of these procedures. Sacrospinous ligament suspension (SSLF) as a typical native tissue repair procedure is one of the most widely used vaginal procedures for correcting apical prolapse. SSLF is typically a suture-based attachment of the vaginal apex to the sacrospinous ligament, either unilaterally or bilaterally usually with specially designed equipment such as Deschamps ligature carrier or Miya hook. However, these instruments are expensive and are not yet widely applied in China. Typical Asian smaller pelvis offers us an optional repair procedure with conventional surgical instruments instead of special instrument. Previous pilot study from Peking Union Medical College Hospital showed promising curative results with conventional surgical instruments in Chinese female patients. The investigation may show us a feasible, economic and effective modified procedure for Asian patients with medium compartment prolapse.

This is a multi-center, prospective clinical trial. Previous studies using conventional surgical instruments for 1-year follow-up showed objective cure rate was 98%, subjective satisfaction was 94%, Considering that the objective cure rate may decrease in multicenter trials, it is assumed that the objective cure rate of multicenter trials can reach 95%. When the sample size is at least 79 patients, 80% of the test efficiency can verify that the objective cure rate is higher than the target value when the bilateral α=0.05. The missing rate was about 10%. The incidence of SSLF failure requiring other operations method due to deep pelvic cavity and unsatisfactory exposure by conventional instruments was about 5%. The final number of cases included in this study should be 100 cases. Ischial spinous fascia fixation (ISFF) will be the replacement procedure if SSLF will not be accomplished by conventional surgical instruments due to unsatisfactory exposure of spinous fascia. The research units will collect perioperative data and complete unified format case report form (CRF) for all selected patients for further analysis. A total of at most 9 months will be required to complete the study after starting up.

Enrollment: 100 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women with apical prolapse with POP-Q III or IV
2. Unilateral (all sutured to right sacrospinous ligament) SSLF is planned，while with vaginal hysterectomy, anterior/posterior vaginal wall repair 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
2. Women who have contraindication for surgical procedure
3. Women who are unable to comply with the study procedures