Recurrence of Dyschezia in Rectal Prolapse, Rectocele and Elytrocele (PEXITY)

Rate of Recurrence of Dyschezia in Rectal Prolapse, Rectocele and Elytrocele at 10 Years and Over After Rectopexy Intervention.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rectal Prolapse
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

• Study Contact: Name: Giorgia Mastronicola; Phone Number: 04 76 76 70 79; Email: GMastronicola@chu-grenoble.fr
• Study Contact Backup: Name: Fatah TIDADINI; Phone Number: 04 76 76 70 79; Email: FTidadini@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France, 38043
    • Chu Grenoble Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

- Patient operated for rectal prolapse or enterocele for 10 or more

Description

Inclusion Criteria:

• Patient operated for rectal prolapse or enterocele for 10 or more
• Age 18 and over
• Patients informed

Exclusion Criteria:

- Patient opposition

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of recurrence leading to reoperation within 10 years of rectopexy intervention for "rectal prolapse, enterocele or elytrocele".	The rate of re-operations for recurrence of rectal prolapse, enterocele or elytrocele within 10 years of the "index" intervention.	10 years

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Study Director: Jean-Luc FAUCHERON, Chu Grenoble Alpes; Principal Investigator: Giorgia Mastronicola, Chu Grenoble Alpes

Publications and helpful links

General Publications

• D'Hoore A, Cadoni R, Penninckx F. Long-term outcome of laparoscopic ventral rectopexy for total rectal prolapse. Br J Surg. 2004 Nov;91(11):1500-5. doi: 10.1002/bjs.4779.
• Faucheron JL, Voirin D, Riboud R, Waroquet PA, Noel J. Laparoscopic anterior rectopexy to the promontory for full-thickness rectal prolapse in 175 consecutive patients: short- and long-term follow-up. Dis Colon Rectum. 2012 Jun;55(6):660-5. doi: 10.1097/DCR.0b013e318251612e.
• Faucheron JL, Trilling B, Girard E, Sage PY, Barbois S, Reche F. Anterior rectopexy for full-thickness rectal prolapse: Technical and functional results. World J Gastroenterol. 2015 Apr 28;21(16):5049-55. doi: 10.3748/wjg.v21.i16.5049.
• Trilling B, Sage PY, Reche F, Barbois S, Waroquet PA, Faucheron JL. Early experience with ambulatory robotic ventral rectopexy. J Visc Surg. 2018 Feb;155(1):5-9. doi: 10.1016/j.jviscsurg.2017.05.005. Epub 2018 Feb 1.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Actual): March 9, 2023
• Study Completion (Anticipated): September 9, 2023

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Hernia; Pelvic Organ Prolapse; Recurrence; Prolapse; Constipation; Rectocele; Rectal Prolapse
• Other Study ID Numbers: 38RC20.290; 2020-A02325-34 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No