Prophylactic Laparoscopic Suspension After McCall

  • STATUS
    Recruiting
  • End date
    Dec 8, 2027
  • participants needed
    182
  • sponsor
    University Hospital Inselspital, Berne
Updated on 8 November 2021

Summary

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.

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.

Details
Condition Pelvic Prolapse
Treatment McCall suture, Standard cuff closure
Clinical Study IdentifierNCT04560543
SponsorUniversity Hospital Inselspital, Berne
Last Modified on8 November 2021

Eligibility

Yes No Not Sure

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
Transgender population
Conversion from laparoscopy to laparotomy
Inability to understand the study protocol
Clear my responses

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