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 range18 Years

SexFEMALE

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.

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

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

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 range18 Years

SexFEMALE

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

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