UnknownNot Applicable

A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy

Belgium150 participantsStarted 2021-02-08

Plain-language summary

The purpose of this observational study is to evaluate the clinical outcome of a modified d'Hoore technique for laparoscopic ventral mesh rectopexy in patients with primary rectal prolapse, rectocele and/or enterocele.The goal of the study will be achieved by reporting the peri- and postoperative complications ((serious) adverse events), recurrences and re-interventions. Pre-operative to postoperative changes in pain, functional outcome and quality of life will be evaluated as well.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female patients. * Patient ≥ 18 years of age at study entry. * Patient and investigator signed and dated the informed consent form prior to the index-procedure. * Patient with primary rectal prolapse (grades I to V according to the Oxford scale), rectocele and/or enterocele. Exclusion Criteria: * Patient is unable / unwilling to provide informed consent. * Patient with recurrent rectal prolapse, rectocele and/or enterocele. * Patient is unable to comply with the study protocol or proposed follow-up visits. * Patient has a contra-indication for laparoscopic ventral mesh rectopexy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Procedural efficacy - Number of participants with (serious) adverse events

Timeframe: During procedure

Procedural efficacy - Conversion rate to laparotomy during the index procedure

Timeframe: During procedure

Procedural efficacy - Number of participants with (serious) adverse events

Timeframe: At discharge (assessed up to 1 week)

Procedural efficacy - Number of re-interventions

Timeframe: At discharge (assessed up to 1 week)

Procedural efficacy - Number of participants with (serious) adverse events

Timeframe: Follow-up 1: 6 - 10 weeks after the procedure

Procedural efficacy - Number of re-interventions

Timeframe: Follow-up 1: 6 - 10 weeks after the procedure

Procedural efficacy - Number of post-operative recurrences

Timeframe: Follow-up 1: 6 - 10 weeks after the procedure

Trial details

NCT IDNCT04564677

SponsorDuomed

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-11-30

Contact for this trial

Stephanie De Munter, PhD

+32 (0)11 28 69 48 stephanie.de.munter@archerresearch.eu

View on ClinicalTrials.gov More Rectocele trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Procedural efficacy - Number of participants with (serious) adverse events

Timeframe: During procedure

Procedural efficacy - Conversion rate to laparotomy during the index procedure

Timeframe: During procedure

Procedural efficacy - Number of participants with (serious) adverse events

Timeframe: At discharge (assessed up to 1 week)

Procedural efficacy - Number of re-interventions

Timeframe: At discharge (assessed up to 1 week)

Procedural efficacy - Number of participants with (serious) adverse events

Timeframe: Follow-up 1: 6 - 10 weeks after the procedure

Procedural efficacy - Number of re-interventions

Timeframe: Follow-up 1: 6 - 10 weeks after the procedure

Procedural efficacy - Number of post-operative recurrences

Timeframe: Follow-up 1: 6 - 10 weeks after the procedure