Rectal ProlapseNCT07848308
Clinical Outcomes of Rectopexy for Rectal Prolapse
An observational study of Rectal Prolapse and Fecal Incontinence, run by Lukas Marti at 1 site in Switzerland.
Trial summary
This study evaluates the clinical outcomes of patients who underwent rectopexy for rectal prolapse, ODS or FI. Rectopexy is a surgical procedure used to restore and fix the rectum in its normal position. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Prolapse, Fecal Incontinence, Rectopexy
- What is being tested?
- anterior mesh rectopexy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2011to 31 Dec 2035
- How long will I take part?
- 120 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients who underwent rectopexy at the participating institution from 2011 onward because of external rectal prolapse, ODS or FI. The study population includes patients with available clinical and postoperative follow-up data allowing assessment of recurrence, postoperative complications, and functional outcomes after rectopexy.
Who may be able to join
- Adult patients aged 18 years or older Diagnosis of external rectal prolapse, ODS or FI Are planned to undergo rectopexy for rectal prolapse at the participating institution Availability of postoperative follow-up data
Who cannot join
- Age under 18 years No informed consent Insufficient clinical documentation to assess the study outcomes No postoperative follow-up available
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
HOCH Health Ostschweiz Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9000
About this study
Official title: Rectopexy Outcome Study (RPE): Clinical Outcomes After Rectopexy for Rectal Prolapse
This study evaluates the clinical outcomes of patients who underwent rectopexy for rectal prolapse, ODS or FI. Rectopexy is a surgical procedure used to restore and fix the rectum in its normal position. The study examines treatment success, recurrence of rectal prolapse, functional outcomes, and postoperative complications. The aim is to better understand the long-term effectiveness and safety of rectopexy and to identify factors that may be associated with favorable or unfavorable outcomes.
- Conditions
- Rectal Prolapse, Fecal Incontinence, Rectopexy, Obstructive Defecation Syndrome, Intussusception of Rectum
- Being tested
- anterior mesh rectopexy
- Keywords
- rectopexy, anterior messe rectopexy, d'Hoore's, ODS, intussuseption, rectal prolapse
- Medical subject headings
- Rectal Prolapse, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior mesh rectopexyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients After Rectopexy for Rectal Prolapse | Patients who underwent rectopexy for rectal prolapse, ODS or Fecal Incontinence are included in this observational cohort. Clinical outcomes after surgery are assessed, including symptoms recurrence, recurrence of rectal prolapse, postoperative complications, and functional outcomes. No study-specific intervention is performed. Special subgroups as patients also operated for decent in the middle/anterior compartement might be accessed separately. Receives: Procedure: anterior mesh rectopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of symptoms after Rectopexy (ODS, Prolapse, FI)
Proportion of patients with clinically diagnosed objective recurrence after rectopexy. Recurrence is defined as reappearance of symptoms (as FI, full-thickness external rectal prolapse) during follow-up.
Measured: From surgery until the end of follow-up, up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Jan 2011
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal ProlapseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 120 Months
Sponsor and investigators
- Lead sponsor
- Lukas Marti
- Sponsor type
- University, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen
- Responsible party
- Sponsor-investigator, Lukas Marti, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848308
- Sponsor's protocol ID
- 2019-01331
- Other IDs
- 2019
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study is based on clinical data collected within the participating institution and no external data-sharing plan has been established. Data will be handled in accordance with applicable ethical, legal, and data protection requirements. If a journal wants to check the data for a publication an anonymised sample of the patient data might be supplied.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectopexy Outcome Study (RPE): Clinical Outcomes After Rectopexy for Rectal Prolapse
- ClinicalTrials.gov ID
- NCT07848308
- Acronym / sponsor ID
- 2019-01331
- Conditions
- Rectal Prolapse, Fecal Incontinence, Rectopexy, Obstructive Defecation Syndrome, Intussusception of Rectum
- Keywords
- rectopexy, anterior messe rectopexy, d'Hoore's, ODS, intussuseption, rectal prolapse
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Lukas MartiUniversity, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 30 Sep 2026 (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.
This study evaluates the clinical outcomes of patients who underwent rectopexy for rectal prolapse, ODS or FI. Rectopexy is a surgical procedure used to restore and fix the rectum in its normal position. The study examines treatment success, recurrence of rectal prolapse, functional outcomes, and postoperative complications. The aim is to better understand the long-term effectiveness and safety of rectopexy and to identify factors that may be associated with favorable or unfavorable outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 120 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients After Rectopexy for Rectal Prolapse | – | Procedure: anterior mesh rectopexyPatients who underwent rectopexy for rectal prolapse, ODS or Fecal Incontinence are included in this observational cohort. Clinical outcomes after surgery are assessed, including symptoms recurrence, recurrence of rectal prolapse, postoperative complications, and functional outcomes. No study-specific intervention is performed. Special subgroups as patients also operated for decent in the middle/anterior compartement might be accessed separately. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent rectopexy at the participating institution from 2011 onward because of external rectal prolapse, ODS or FI. The study population includes patients with available clinical and postoperative follow-up data allowing assessment of recurrence, postoperative complications, and functional outcomes after rectopexy.
Key inclusion criteria (1 listed)
- Adult patients aged 18 years or older Diagnosis of external rectal prolapse, ODS or FI Are planned to undergo rectopexy for rectal prolapse at the participating institution Availability of postoperative follow-up data
Key exclusion criteria (1 listed)
- Age under 18 years No informed consent Insufficient clinical documentation to assess the study outcomes No postoperative follow-up available
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 |
|---|---|---|
| anterior mesh rectopexy | Procedure or surgery | Patients After Rectopexy for Rectal Prolapse |
Primary outcome
Recurrence of symptoms after Rectopexy (ODS, Prolapse, FI)
Time frame: From surgery until the end of follow-up, up to 10 years
Proportion of patients with clinically diagnosed objective recurrence after rectopexy. Recurrence is defined as reappearance of symptoms (as FI, full-thickness external rectal prolapse) during follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study is based on clinical data collected within the participating institution and no external data-sharing plan has been established. Data will be handled in accordance with applicable ethical, legal, and data protection requirements. If a journal wants to check the data for a publication an anonymised sample of the patient data might be supplied.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Fecal Incontinence, run by Lukas Marti at 1 site in Switzerland.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Recurrence of symptoms after Rectopexy (ODS, Prolapse, FI) (time frame: From surgery until the end of follow-up, up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.