Clinical trial NCT04306250: Comparison of Posterior and Anterior Approach to Sacrospinous Ligament Apical Fixation - Randomized Controlled Trial
Official title: Comparison of Posterior and Anterior Approach to Sacrospinous Ligament Apical Fixation - Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Surgical Procedure, Unspecified
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Compound cure rate
timeFrame: 6-month (and will be further followed yearly until 2 years of total follow up)
Secondary outcomes:
measure: Duration of surgery
timeFrame: From the time of the first cut of the surgery to the time the surgery ends (as documented in the surgery report), up to 240 minutes
measure: Change in hemoglobin level from pre-operation level to post-operative level in g/dl units
timeFrame: Hb level will be measured up to 1 month before the surgery and at the 24 hours after surgery. Further examinations will be taken if there is clinical suspicious for bleeding, up to the day of discharge)
measure: Intraoperative complications
timeFrame: Any complication the occured during the duration of the surgery
measure: Peri-operative complications
timeFrame: Any complications that occured from the end of the surgery until the first check-up visit (6 weeks after rthe surgery)
measure: Maximal pain score
timeFrame: Maximal pain level during the 6 weeks after the surgery
measure: Change in PFDI-20 score
timeFrame: 6, 12 and 24 months post the operation
measure: Patient global impression of improvement from surgery
timeFrame: 6, 12 and 24 months post the operation
measure: Cure rate at 12 months post-operation
timeFrame: 12 months post the operation
measure: Cure rate at 24 months post-operation
timeFrame: 24 months post the operation
measure: long term complications
timeFrame: 6, 12 and 24 months post the operation
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
affiliation: haemek medical center
name: meirav breverman, MD
role: PRINCIPAL_INVESTIGATOR
References: