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Search / Trial NCT04564677

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

Launched by DUOMED · Sep 21, 2020

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a surgical technique called the modified d'Hoore technique for treating conditions like rectal prolapse, rectocele, and enterocele in women. The goal is to see how well this method works by looking at any complications during and after surgery, as well as how effective it is in reducing pain and improving quality of life for patients. The trial is currently recruiting female participants aged 18 and older who have these specific conditions for the first time.

If you join the study, you'll undergo the surgery and be monitored for any side effects or need for further operations. Researchers will also check how your pain levels and everyday activities change from before the surgery to after. It's important to know that this study is only for women who are experiencing these conditions for the first time and who can give informed consent and attend follow-up visits. If you have had these conditions before or cannot follow the study requirements, you may not be eligible to participate.

Gender

FEMALE

Eligibility criteria

  • 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.

About Duomed

Duomed is a leading clinical trial sponsor dedicated to advancing medical research and innovation. With a strong focus on developing cutting-edge therapies and diagnostic solutions, Duomed partners with healthcare institutions and research organizations to facilitate rigorous clinical studies across various therapeutic areas. Committed to ethical standards and patient safety, Duomed employs a robust framework for trial design and execution, ensuring compliance with regulatory requirements while fostering collaboration among stakeholders. Through its comprehensive approach, Duomed aims to enhance patient outcomes and contribute to the evolution of healthcare.

Locations

Genk, , Belgium

Patients applied

0 patients applied

Trial Officials

Anne Dams, MD

Principal Investigator

Ziekenhuis Oost-Limburg (ZOL)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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