Health TrialsbyHealthPanel

Prophylactic Laparoscopic Suspension After McCall

ConditionProlapse Pelvic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

LSC simple hysterectomy,

Neg. SS test if premenopausal

>18j,

Consent to participate in the study

Disqualifiers

Prolapse as indication for surgery

Known or suspected non-compliance

Additional incontinence procedures

Patients with deep infiltrating endometriosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • McCall suture

    Procedure/Surgery

    Laparoscopic suture including the uterosacral ligaments and the peritoneum

  • Standard cuff closure

    Procedure/Surgery

    Standard laparoscopic barbed suture of the vaginal cuff

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: McCall sutureExperimental treatment 1 intervention
Group B: standard cuff closureSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Primary Quantification by the Pelvic organ prolapse Scoring system (POP-Q), ranges from -10 (low) to +10 (high), better outcome with higher score endpoint is the prolapse of the apical compartment (point D in the POP-Q score, vaginal dome in relation to the hymen) after 5 years. Point D is a value measured in centimeters. Depending on vaginal length, it could vary between +10 and -10cm. Reference point of all measurements is the hymen.

Time frame
5 years

Secondary outcomes

1

Sexual function

Quantification by the Female Sexual Function Index, Score 0 - 5, better outcome with higher score

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Insel Gruppe AG, University Hospital Bern

Lead sponsor

Source ClinicalTrials.gov
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