NCT03624764

Brief Summary

The treatment of gynecological prolapse (organ removal) can be done by laparoscopy or vaginally. Laparoscopy is used in 1 out of 2 cases, but learning is difficult and operation time is long. One of the technical difficulties is related to the sutures to the threads. Some surgeons therefore use a glue to fix prosthetic reinforcements more easily and quickly, but this sizing technique has only been evaluated very little. Our study proposes to compare the technique of suture with the thread at the gluing of the prostheses in order to validate the merits of this new technique

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2020

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

2.7 years

First QC Date

June 19, 2018

Last Update Submit

February 8, 2021

Conditions

Prolapse

Keywords

promontofixationprolapse surgery

Outcome Measures

Primary Outcomes (1)

  • Operative time

    The time elapsed between incision and closure

    one day

Secondary Outcomes (12)

  • Collection of intra-operative complications

    one day

  • Collection of per-operative complications

    one day

  • Collection of complications at 6 weeks

    6 weeks

  • Tolerance of the prosthesis

    6 weeks

  • Tolerance of the prosthesis

    6 months

  • +7 more secondary outcomes

Study Arms (2)

Promontofixation using glue

EXPERIMENTAL

Patients in this arm will have a laparoscopic promontofixation using a biocompatible cyanoacrylate adhesive replacing some sutures to maintain the strips.

Procedure: Laparostopic promontofixation using surgical glue

Promontofixation using threads

ACTIVE COMPARATOR

Patients in this arm will have a laparoscopic promontofixation using sutures with threads to maintain the strips.

Procedure: Laparostopic promontofixation using threads

Interventions

Laparostopic promontofixation using surgical gluePROCEDURE

The technique involves implanting a prosthetic tissue (tape) between the bladder and the vagina, suspending the cervix or the vagina affectionately, associated or not with a posterior strip placed between the rectum and the vagina fixed on the small pelvis muscles. Each strip is held by the surgical glue (cyanoacrylate biocompatible adhesive)

Promontofixation using glue
Laparostopic promontofixation using threadsPROCEDURE

The technique involves implanting a prosthetic tissue (tape) between the bladder and the vagina, suspending the cervix or the vagina affectionately, associated or not with a posterior strip placed between the rectum and the vagina fixed on the small pelvis muscles. Each strip is held by sutures with threads

Promontofixation using threads

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\> 40 years
  • Surgical indication of prolapse cure by promontofixation
  • Valid social insurance
  • French spoken and written
  • Informed consent signed

You may not qualify if:

  • Concomitant rectopexy
  • Concomitant Hysterectomy
  • Associated surgical procedure not compatible with measurement of operative time
  • Refusal to participate in the study
  • Pregnant or lactating woman (Article L 1121-5 of the french code of public health)
  • Vulnerable persons (Article L 1121-6 of the french code of public health)
  • Majors subject to legal protection or unable to express their consent (Article 1121-8 of the CSP)
  • Participation in another protocol for less than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Beau Soleil

Montpellier, 34070, France

Location

MeSH Terms

Conditions

Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Christophe Courtieu

    Clinqieu Beau Soleil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2018

First Posted

August 10, 2018

Study Start

January 4, 2017

Primary Completion

October 4, 2019

Study Completion

January 4, 2020

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)