ClinicalTrials.gg
CompletedNCT04627610PEXITYUpdated May 14, 2024

Recurrence of Dyschezia in Rectal Prolapse, Rectocele and Elytrocele

An observational study in Rectal Prolapse, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
350
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Rectal Prolapse

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03

In context

Rectal Prolapse

55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.

This study's enrollment of 350 is above the median of 200 across 21 observational studies indexed under Rectal Prolapse.

Browse Rectal Prolapse studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patient opposition
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
350 participants (actual)
Patient registry
No

Interventions

  • OtherRectal prolapse, rectocele and elytrocele

    Recurrence of dyschesia on rectal prolapse, rectocele and elytrocele

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 years

07

Study locations

1 site
  • Chu Grenoble Alpes
    Grenoble, 38043, France
08

References and documents

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. PubMed 15499644 ↗
  • 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. PubMed 22595845 ↗
  • 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. PubMed 25945021 ↗
  • 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. PubMed 29396113 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2022 to primary completion in Mar 2023, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2020
First posted
Nov 13, 2020
StartActual
Mar 9, 2022
Primary completionActual
Mar 9, 2023
CompletionActual
Sep 9, 2023
Last update
May 14, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04627610
Responsible party
Sponsor
First posted
Nov 13, 2020
Start date
Mar 9, 2022
Primary completion
Mar 9, 2023
Completion
Sep 9, 2023
Last update
May 14, 2024

Study contacts

Jean-Luc FAUCHERON
study director · CHU Grenoble Alpes
Giorgia Mastronicola
principal investigator · CHU Grenoble Alpes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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