RecruitingNot ApplicableNCT04560543

Prophylactic Laparoscopic Suspension After McCall

Prophylactic Laparoscopic Suspension After McCall - Benefit and Longterm Outcome


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

182 participants

Start Date

May 15, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • LSC simple hysterectomy,
  • Neg. SS test if premenopausal
  • \>18j,
  • Consent to participate in the study
  • Understanding of the German language

Exclusion Criteria9

  • 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

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Interventions

PROCEDUREMcCall suture

Laparoscopic suture including the uterosacral ligaments and the peritoneum

PROCEDUREStandard cuff closure

Standard laparoscopic barbed suture of the vaginal cuff


Locations(1)

Universitätsfrauenklink Inselspital

Bern, Switzerland

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NCT04560543


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