Comparison of Posterior and Anterior Approach to Sacrospinous Ligament Apical Fixation - Randomized Controlled Trial

NCT ID: NCT04306250

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-09
• Study Completion Date: 2025-12-31

Brief Summary

Pelvic organ prolapse (POP) is a common problem among women. Apical prolapse (AP) is a prolapse of the uterus, or vaginal cuff, in women post hysterectomy.

Apical fixation to the sacrospinous ligament (SSLF) was first introduced in 1968 by K.RICHTER. .In a large review study, the subjective cure rate after SSLF ranged from 70 to 98%, while objective cure rate was 67-97%.

The success rates of SSLF in a randomized study comparing SSLF to uterosacral ligament fixation after two years were 63.1%. In women with combined apical and anterior wall prolapse, SSLF can be performed in two ways: anterior access through the anterior vaginal wall or posterior approach through the posterior vaginal wall.

A retrospective comparison of the two methods was performed, demonstrating some efficacy to the anterior approach over the posterior approach mainly in respect to the vaginal length.

From the literature review to date, no comparisons were made between the methods in a randomized controlled trial.

Objective: To compare the success rates between two approaches (anterior and posterior) for SSLF

Detailed Description

Pelvic organ prolapse (POP) is a common problem among women and its incidence is rising due to population aging. Approximately 11-19% of women will undergo surgery for pelvic organ prolapse (POP) or urinary incontinence during their lifetime and approximately 30% will need repeat surgery during their lifetime .Apical prolapse (AP) is a prolapse of the uterus, or vaginal cuff, in women post hysterectomy. The severity of the prolapsed organ can be graded according to the POP-Q classification .There are several approaches to apical fixation, some of which are done vaginally and include fixation by sutures to the uterosacral ligament (USLF) or the sacrospinous ligament (SSLF). A mesh can be used for ligament fixation as well. The abdominal approach is also an option, the sacro-colpo-pexy fixation using a Y mesh. Apical fixation to the SSL was first introduced in 1968 by K.RICHTER. medical devices such as the Capio that assist in performing SSLF were also developed with ease.

In a review article that included 2,390 women undergoing SSLF subjective cure rate ranged from 70 to 98%, while objective cure rate was 67-97% .Such fixation in combination with posterior or anterior wall repair, especially after hysterectomy, showed a 94% objective cure rate at 7-year postoperative follow-up. A randomized study (The "OPTIMAL randomised trial") comparing SSLF with USLF found no preference for either method. Success rates were measured according to three criteria - 1) no significant vaginal dome or one of the vaginal walls 2) no vaginal bulge symptoms 3) no need for repeated surgery within two years of the original surgery. According to this study, the success rates of SSLF after two years were 63.1%.

Among women with anterior vaginal wall prolapse and AP, SSLF can be performed in two ways: anterior access, ie dissection through the anterior wall of the vagina or fixation through the posterior wall of the vagina. A retrospective comparison of the two methods was performed, demonstrating some efficacy in anterior approach in terms of vaginal length and postoperative apical fixation with less reference to healing rates or impact on the anterior compartment, compared with a posterior approach.

From the literature review to date, no comparisons were made between the methods in a randomized controlled trial.

Objective: To compare the success rates of two approaches (anterior and posterior) for SSLF

Conditions

Pelvic Organ Prolapse; Surgical Procedure, Unspecified

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

anterior approach for apical fixation to the SSL

In this group the apical fixation will be done using the anterior access, ie dissection through the anterior vaginal wall.

Group Type: EXPERIMENTAL

Apical prolapse fixation - anterior access

Intervention Type: PROCEDURE

The surgery is done in anterior access

posterior approach for apical fixation to the SSL

In this group the apical fixation will be done using the posterior access, ie fixation through the vaginal posterior wall.

Group Type: ACTIVE_COMPARATOR

Apical prolapse fixation - posterior access

Intervention Type: PROCEDURE

The surgery is done in posterior access

Interventions

Apical prolapse fixation - anterior access

The surgery is done in anterior access

Intervention Type: PROCEDURE

Apical prolapse fixation - posterior access

The surgery is done in posterior access

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Women with grade 2 or above apical prolapse, according to POP Q, combined with Grade II or above of anterior wall prolapse.
• Women who suffer from symptomatic POP and care for a surgical treatment

Exclusion Criteria

• Women with a contra-indication for surgical treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Meirav Braverman

medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

meirav breverman, MD

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

Locations

Haemek Medical Center

Afula, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

meirav breverman, MD

Role: CONTACT

meirav_al@clalit.org.il

97246495507

eyal rom, MD

Role: CONTACT

eyalro@clalit.org.il

97246495507

Facility Contacts

Meirav Breverman, MD

Role: primary

meirav_al@clalit.org.il

Sivan Witzman

Role: backup

sivan_we@clalit.org.il

972-4-6495348

Other Identifiers

145-19

Identifier Type: -

Identifier Source: org_study_id