Evaluating a modified technique for laparoscopic surgery to treat rectal issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the clinical outcomes of a modified d'Hoore technique for laparoscopic ventral mesh rectopexy in female patients suffering from primary rectal prolapse, rectocele, and/or enterocele. The study will monitor peri- and postoperative complications, recurrences, and the need for re-interventions. Additionally, it will evaluate changes in pain, functional outcomes, and quality of life from pre-operative to postoperative stages. The intervention involves the use of Ifabond surgical adhesive during the procedure.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ziekenhuis Oost-Limburg (ZOL)
  Genk, Belgium Recruiting

Study contacts

• Principal investigator: Anne Dams, MD — Ziekenhuis Oost-Limburg (ZOL)
• Study coordinator: Stephanie De Munter, PhD
• Email: stephanie.de.munter@archerresearch.eu
• Phone: +32 (0)11 28 69 48

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Non-surgical treatment for women with pelvic organ prolapse and bowel-emptying problems

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.