Evaluating a modified technique for laparoscopic surgery to treat rectal issues
A Prospective Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy
Duomed · NCT04564677
This study is testing a new way to perform laparoscopic surgery for women with rectal problems to see if it helps improve their recovery and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Duomed (industry) |
| Locations | 1 site (Genk) |
| Trial ID | NCT04564677 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older with primary rectal prolapse, rectocele, or enterocele.
Not a fit: Patients with recurrent rectal prolapse, rectocele, or enterocele, or those unable to comply with the study protocol will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and quality of life for patients with rectal prolapse and related conditions.
How similar studies have performed: While this specific approach may be novel, similar techniques in laparoscopic surgery have shown promising results in other studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Genk
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rectocele, Enterocele, Rectal Prolapse