Sacrospinous Ligament Fixation vs Ischial Spine Fascia Fixation

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Urogenital Prolapse

Treatments: Procedure: ischial spine fascia fixation; Procedure: sacrospinous ligament fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT03005613

RC-H0407-8160061244

Details and patient eligibility

About

A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.

Full description

Investigational intervention：SSLF or ISFF operations

Study title：A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.

Principal Investigator：Chang Ren, M.D., Department of Obstetrics & Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.

Study subjects：Adult patients with symptomatic stage II~IV pelvic organ prolapse will be eligible if all the inclusion criteria are met and without any reason for exclusion.

Study objectives：The primary objective of this study is to assess the short and mid-term efficacy of Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation in treating stage II~ IV pelvic organ prolapse and their recurrence rate as well as their impacts on quality of life.

Study design：Prospective, Single-Blind, Randomized, Clinical Trial

Intervention：

• ISFF group：Patients receive ISFF according to randomization.
• SSLF group：Patients receive SSLF according to randomization

Sample size：76 patients (38 in ISFF group, 38 in SSLF group)

Primary endpoint:

•objective success rates at 3 months after operations.

Secondary endpoints:

• peri-operative parameters .
• subjective satisfactory rates at 1 year after operations
• quality of life questionnaires at 1 year after operations

Safety endpoints: complications

Enrollment: 76 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age≤65 years, for those scheduled to receive hysterectomy age≥40 years
• patients with symptomatic stage II~IV uterine or vaginal vault prolapse
• receiving SSLF or ISFF in the gynecological department at Peking Union Medical College Hospital

Exclusion criteria

• plans to live abroad within follow-up span
• contradiction to these two operations: acute genital infection, narrow vagina (less than two finger-breadth), too-ill to receive operations
• patients with hip joint problem who could not pose a lithotomy position

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

sacrospinous ligament fixation group

Active Comparator group

Description:

The patients will receive sacrospinous ligament fixation operation.

Treatment:

Procedure: sacrospinous ligament fixation

ischial spine fascia fixation group

Experimental group

Description:

The patients will receive ischial spine fascia fixation operation.

Treatment:

Procedure: ischial spine fascia fixation