Rectal ProlapsePEXITYNCT04627610
Recurrence of Dyschezia in Rectal Prolapse, Rectocele and Elytrocele
An observational study of Rectal Prolapse, run by University Hospital, Grenoble at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Prolapse
- What is being tested?
- Rectal prolapse, rectocele and elytrocele
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2022to 9 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - Patient operated for rectal prolapse or enterocele for 10 or more
Who may be able to join
- Patient operated for rectal prolapse or enterocele for 10 or more
- Age 18 and over
- Patients informed
Who cannot join
- Patient opposition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Rectal Prolapse
- Being tested
- Rectal prolapse, rectocele and elytrocele
- Medical subject headings
- Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal prolapse, rectocele and elytroceleOther
Recurrence of dyschesia on rectal prolapse, rectocele and elytrocele
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start9 Mar 2022
- Primary completion9 Mar 2023
- Study completion9 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rectal ProlapseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc FAUCHERON, Study director, CHU Grenoble AlpesGiorgia Mastronicola, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627610
- Sponsor's protocol ID
- 38RC20.290
- Other IDs
- 2020-A02325-34
- Acronym
- PEXITY
- Status last verified
- May 2024
- First submitted
- 6 Nov 2020
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 15499644Faucheron 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 22595845Faucheron 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 25945021Trilling 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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Recurrence of Dyschezia in Rectal Prolapse, Rectocele and Elytrocele at 10 Years and Over After Rectopexy Intervention.
- ClinicalTrials.gov ID
- NCT04627610
- Acronym / sponsor ID
- PEXITY / 38RC20.290
- Conditions
- Rectal Prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Sep 2023 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Patient operated for rectal prolapse or enterocele for 10 or more
Key inclusion criteria (3 listed)
- Patient operated for rectal prolapse or enterocele for 10 or more
- Age 18 and over
- Patients informed
Key exclusion criteria (1 listed)
- Patient opposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectal prolapse, rectocele and elytroceleRecurrence of dyschesia on rectal prolapse, rectocele and elytrocele | Other | – |
Primary outcome
rate of recurrence leading to reoperation within 10 years of rectopexy intervention for "rectal prolapse, enterocele or elytrocele".
Time frame: 10 years
The rate of re-operations for recurrence of rectal prolapse, enterocele or elytrocele within 10 years of the "index" intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 15499644D'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.
- Background: PubMed 22595845Faucheron 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.
- Background: PubMed 25945021Faucheron 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.
- Background: PubMed 29396113Trilling 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Luc FAUCHERON study director
CHU Grenoble Alpes
Giorgia Mastronicola principal investigator
CHU Grenoble Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Prolapse, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of recurrence leading to reoperation within 10 years of rectopexy intervention for "rectal prolapse, enterocele or elytrocele". (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04627610, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.