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

H

HaEmek Medical Center, Israel

Status

Enrolling

Conditions

Surgical Procedure, Unspecified
Pelvic Organ Prolapse

Treatments

Procedure: Apical prolapse fixation - posterior access
Procedure: Apical prolapse fixation - anterior access

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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

Enrollment

280 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

280 participants in 2 patient groups

anterior approach for apical fixation to the SSL
Experimental group
Description:
In this group the apical fixation will be done using the anterior access, ie dissection through the anterior vaginal wall.
Treatment:
Procedure: Apical prolapse fixation - anterior access
posterior approach for apical fixation to the SSL
Active Comparator group
Description:
In this group the apical fixation will be done using the posterior access, ie fixation through the vaginal posterior wall.
Treatment:
Procedure: Apical prolapse fixation - posterior access

Trial contacts and locations

1

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Central trial contact

eyal rom, MD; meirav breverman, MD

Data sourced from clinicaltrials.gov

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