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Prophylactic Laparoscopic Suspension After McCall (LAPCALL)

Primary Purpose

Prolapse Pelvic

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
McCall suture
Standard cuff closure
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prolapse Pelvic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsfrauenklink InselspitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

McCall suture

standard cuff closure

Arm Description

Uterus removal by laparoscopy with usual vaginal closure and additional (McCall) suture, which is intended to prevent descent.

Uterus removal by laparoscopy with usual vaginal closure without additional (McCall) suture. (as performed so far)

Outcomes

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
September 17, 2020
Last Updated
October 26, 2021
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT04560543
Brief Title
Prophylactic Laparoscopic Suspension After McCall
Acronym
LAPCALL
Official Title
Prophylactic Laparoscopic Suspension After McCall - Benefit and Longterm Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolapse Pelvic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
McCall suture
Arm Type
Experimental
Arm Description
Uterus removal by laparoscopy with usual vaginal closure and additional (McCall) suture, which is intended to prevent descent.
Arm Title
standard cuff closure
Arm Type
Sham Comparator
Arm Description
Uterus removal by laparoscopy with usual vaginal closure without additional (McCall) suture. (as performed so far)
Intervention Type
Procedure
Intervention Name(s)
McCall suture
Other Intervention Name(s)
Uterosacral Ligament Suspension
Intervention Description
Laparoscopic suture including the uterosacral ligaments and the peritoneum
Intervention Type
Procedure
Intervention Name(s)
Standard cuff closure
Intervention Description
Standard laparoscopic barbed suture of the vaginal cuff
Primary Outcome Measure Information:
Title
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.
Description
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 Outcome Measure Information:
Title
Sexual function
Description
Quantification by the Female Sexual Function Index, Score 0 - 5, better outcome with higher score
Time Frame
5 years

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. Transgender population Conversion from laparoscopy to laparotomy Inability to understand the study protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Höhn, MD
Phone
0316321010
Ext
0316321010
Email
diana.hoehn@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel D Mueller, Prof.
Organizational Affiliation
Department of Gynaecology, University Hospital, Berne
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsfrauenklink Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prophylactic Laparoscopic Suspension After McCall

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