Prophylactic Laparoscopic Suspension After McCall
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: McCall suture, Standard cuff closure.
- Who it may be relevant to
- Registry conditions: Prolapse Pelvic. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prophylactic Laparoscopic Suspension After McCall - Benefit and Longterm Outcome
Overview
There is prove of prolapse prevention in vaginal hysterectomy using the McCall suture. Poor and especially no long-term data exists for a standardized laparoscopic approach, but the few studies could show good anatomic results. The aim is to test the effectiveness of the laparoscopic McCall suture compared to usual vaginal cuff closure in a randomized controlled double-blinded trial.
Detailed description
182 patients will be enrolled in the study. We randomize the patient before surgery and information about the procedure will be transmitted to the theatre in a sealed envelope. The surgeon will open the envelope just before surgery. For randomization we apply a 1:1 allocation (standard vaginal cuff closure VS standard vaginal cuff closure with McCall sutures). The McCall suture is standardized: we apply a purse-string suture including both USL and the peritoneum.
Follow-up visits measuring POP-Q are planned after 6 weeks and yearly until 5 years.
Interventions
- Procedure McCall suture
Laparoscopic suture including the uterosacral ligaments and the peritoneum - Procedure Standard cuff closure
Standard laparoscopic barbed suture of the vaginal cuff
Primary outcome measures
- Prolapse of the apical compartment. Primary Quantification by the Pelvic organ prolapse Scoring system (POP-Q) Depending on vaginal length, it could vary between +10 and -10cm. [Time frame: 5 years]
Secondary outcome measures (1)
- Sexual function [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- LSC simple hysterectomy,
- Neg. SS test if premenopausal
- >18j,
- Consent to participate in the study
- Understanding of the German language
Exclusion criteria
- Prolapse as indication for surgery
- Known or suspected non-compliance
- Additional incontinence procedures
- Patients with deep infiltrating endometriosis
- Irradiation pre- or postoperative
- Pregnancy and lactation.
- Conversion from laparoscopy to laparotomy
- Inability to understand the study protocol
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Switzerland · 1 center
- Universitätsfrauenklink Inselspital — Bern
Identifiers
NCT: NCT04560543 · 2020-01046