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

Medical University of Graz

Status: Active, not recruiting

Conditions: Complication; Quality of Life; Surgery; Pelvic Organ Prolapse

Treatments: Procedure: fixation of the vaginal apex

Study type: Interventional

Funder types: Other

Identifiers

NCT03113513

V4 31.01.2016

Details and patient eligibility

About

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.

Full description

The aim of the study is to determine objective anatomical recurrent prolapse after SLF vs McCall. The study is designed as a Randomized Controlled Trial (RCT). Primary study endpoint will be at 12 months, secondary study endpoint at 24 months. The following parameters will be evaluated after one year: anatomical outcome, Quality of Life (QoL), sexual health, reoperations, and complications.

Enrollment: 312 estimated patients

Sex: Female

Ages: 35 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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312 participants in 2 patient groups

McCall culdoplasty

Active Comparator group

Description:

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.

Treatment:

Procedure: fixation of the vaginal apex

Sacrospinous ligament fixation

Active Comparator group

Description:

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.

Treatment:

Procedure: fixation of the vaginal apex