Recurrence of Dyschezia in Rectal Prolapse, Rectocele and Elytrocele

Rectal Prolapse Clinical Trial

— PEXITY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04627610
• Other study ID #: 38RC20.290
• Secondary ID: 2020-A02325-34
• Status: Completed
• Start date: March 9, 2022
• Est. completion date: September 9, 2023

Study information

• Verified date: May 2024
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: September 9, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patient opposition

Related Conditions & MeSH terms

• Constipation
• Prolapse
• Rectal Prolapse
• Rectocele
• Recurrence

Intervention

Other:
• Rectal prolapse, rectocele and elytrocele
Recurrence of dyschesia on rectal prolapse, rectocele and elytrocele

Locations

Country	Name	City	State
France	Chu Grenoble Alpes	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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