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

NCT04306250 | Recruiting

• 1 other identifier: 145-19
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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

Conditions

Pelvic Organ Prolapse; Surgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (1)

• Compound cure rate

  A compound cure rate is composite outcome used to measure the success rate of a surgery designed to repair pelvic organ prolapse. Surgery will be considered successful based on each of the following criteria at the 6-month follow-up (and will be further followed yearly until 2 years of total follow up): A. Lack of apical and anterior wall prolapse beyond stage 1 (POP-Q stage\<=1) b. Subjective success- a negative response ("no" or not at all to the question, "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (Question 3 on the PFDI-20 questionnaire), (score \<2). c. No re-treatment (surgical/ non-surgical) for index compartment

  6-month (and will be further followed yearly until 2 years of total follow up)

Secondary Outcomes (10)

• Duration of surgery

  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

• Change in hemoglobin level from pre-operation level to post-operative level in g/dl units

  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)

• Intraoperative complications

  Any complication the occured during the duration of the surgery

• Peri-operative complications

  Any complications that occured from the end of the surgery until the first check-up visit (6 weeks after rthe surgery)

• Maximal pain score

  Maximal pain level during the 6 weeks after the surgery

Study Arms (2)

anterior approach for apical fixation to the SSL

EXPERIMENTAL

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

Procedure: Apical prolapse fixation - anterior access

posterior approach for apical fixation to the SSL

ACTIVE COMPARATOR

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

Procedure: Apical prolapse fixation - posterior access

Interventions

Apical prolapse fixation - anterior access PROCEDURE

The surgery is done in anterior access

anterior approach for apical fixation to the SSL

Apical prolapse fixation - posterior access PROCEDURE

The surgery is done in posterior access

posterior approach for apical fixation to the SSL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women with a contra-indication for surgical treatment

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Haemek Medical Center

Afula, Israel

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• meirav breverman, MD

  haemek medical center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

meirav breverman, MD

CONTACT

97246495507; meirav_al@clalit.org.il

eyal rom, MD

CONTACT

97246495507; eyalro@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 12, 2020
• Study Start: July 9, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

IL (1)