PEXITY: Recurrence of Dyschezia in Rectal Prolapse, Rectocele and Elytrocele

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Recruiting
CT.gov ID
NCT04627610
Collaborator
(none)
350
1
18
19.4

Study Details

Study Description

Brief Summary

Prolapse of the rectum is a pathology that preferentially affects older women with a significant impact on quality of life. A very large number of therapeutic approaches can be proposed (functional treatment, surgical techniques by perineal approach and surgical techniques by anterior approach).

D'Hoore and Pennix described Ventral Rectopexy with prosthetic reinforcement which is accepted as a standard of treatment in much of Europe for externalized prolapse but remains maligned in much of the world. Due to the relatively recent appearance of this technique and the great variability in the management methods, the long-term results of Ventral Rectopexy have been little studied.

This surgical technique is the preferred approach offered at CHU Grenoble Alpes. Pr Faucheron have internationally recognized experience in surgical grip with a very high patient volume in recent years.

Condition or Disease Intervention/Treatment Phase
  • Other: Rectal prolapse, rectocele and elytrocele

Detailed Description

Prolapse of the rectum is a pathology that preferentially affects older women with a significant impact on quality of life. A very large number of therapeutic approaches can be proposed (functional treatment, surgical techniques by perineal approach and surgical techniques by anterior approach).

D'Hoore and Pennix described Ventral Rectopexy with prosthetic reinforcement which is accepted as a standard of treatment in much of Europe for externalized prolapse but remains maligned in much of the world. Due to the relatively recent appearance of this technique and the great variability in the management methods, the long-term results of Ventral Rectopexy have been little studied.

This surgical technique is the preferred approach offered at CHU Grenoble Alpes. Pr Faucheron have internationally recognized experience in surgical grip with a very high patient volume in recent years.

The objective of this work is to describe the long-term results of this technique.

Study Design

Study Type:
Observational
Anticipated Enrollment :
350 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Rate of Recurrence of Dyschezia in Rectal Prolapse, Rectocele and Elytrocele at 10 Years and Over After Rectopexy Intervention.
Actual Study Start Date :
Mar 9, 2022
Anticipated Primary Completion Date :
Mar 9, 2023
Anticipated Study Completion Date :
Sep 9, 2023

Outcome Measures

Primary Outcome Measures

  1. rate of recurrence leading to reoperation within 10 years of rectopexy intervention for "rectal prolapse, enterocele or elytrocele". [10 years]

    The rate of re-operations for recurrence of rectal prolapse, enterocele or elytrocele within 10 years of the "index" intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient operated for rectal prolapse or enterocele for 10 or more

  • Age 18 and over

  • Patients informed

Exclusion Criteria:
  • Patient opposition

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Grenoble Alpes Grenoble France 38043

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

  • Study Director: Jean-Luc FAUCHERON, CHU Grenoble Alpes
  • Principal Investigator: Giorgia Mastronicola, CHU Grenoble Alpes

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT04627610
Other Study ID Numbers:
  • 38RC20.290
  • 2020-A02325-34
First Posted:
Nov 13, 2020
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022