Comparison of Two Apical Repair Methods in Women Undergoing Repairs for Prolapse

NCT03113513 | Unknown

• 1 other identifier: V4 31.01.2016
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

To date no study has determined prospectively which technique is superior to prevent recurrent Pelvic Organ Prolapse (POP) after vaginal hysterectomy- a major unmet clinical need. The aim of the study is to determine objective anatomical recurrent prolapse after Sacrospinous Ligament Fixation (SLF) vs McCall.

Conditions

Pelvic Organ Prolapse; Surgery; Quality of Life; Complication

Outcome Measures

Primary Outcomes (1)

• Number of patients with stage 2 or higher on the Pelvic Organ Prolapse Quantification System (POP-Q).

  POP-Q stage 2 or higher means any point of the POP-Q system being -1 related to the hymen or below

  12 months after surgery

Secondary Outcomes (4)

• Subjective cure

  12 months after surgery

• Quality of life as determined by a questionnaire

  12 months after surgery

• Sexual health

  12 months after surgery

• Reoperation rate

  12 months after surgery

Study Arms (2)

McCall culdoplasty

ACTIVE COMPARATOR

The McCall culdoplasty will be performed in a modified version as described by McCall in 1957. Specifically, two long acting bioresorbable sutures are put through the specific anatomic landmarks.

Procedure: fixation of the vaginal apex

Sacrospinous ligament fixation

ACTIVE COMPARATOR

The SLF technique will be performed as described by Richter et al (Amreich, 1951). Two long acting bioresorbable sutures are passed through the right sacrospinous ligament and then fixed to the vaginal cuff.

Procedure: fixation of the vaginal apex

Interventions

fixation of the vaginal apex PROCEDURE

In the course of vaginal hysterectomy the vaginal cuff is either fixed to the sacrospinous ligament or to the uterosacral ligament.

McCall culdoplasty; Sacrospinous ligament fixation

Eligibility Criteria

• Age: 35 Years - 80 Years
• Gender Eligibility Details: only women are included into the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• declined/ failed conservative treatment for POP
• planned vaginal hysterectomy with anterior/posterior colporrhaphy as indicated
• any symptomatic POP or stage II prolapse in any compartment
• at least stage I prolapse in the apical department
• women between 35 and 80 years of age
• good German language skills
• any concomitant prolapse surgery (anterior, posterior vaginal repair, suburethral tapes) as indicated
• concomitant salpingo-oophorectomy if indicated

You may not qualify if:

• Unwillingness to participate
• Neurological disorders
• Previous hysterectomy
• Desire to have children
• Connective tissue disorders (i.e. Ehlers-Danlos syndrome, Marfan syndrome)

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

MUGRAZ

Graz, Styria, 8036, Austria

Location

Related Publications (1)

• Colombo M, Milani R. Sacrospinous ligament fixation and modified McCall culdoplasty during vaginal hysterectomy for advanced uterovaginal prolapse. Am J Obstet Gynecol. 1998 Jul;179(1):13-20. doi: 10.1016/s0002-9378(98)70245-5.

  PMID: 9704759 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is designed as a RCT.

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 13, 2017
• Study Start: May 1, 2016
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)