Sacrospinous Ligament Fixation vs Ischial Spine Fascia Fixation

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

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

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

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