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

NCT04564677 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-10-10

No results posted yet for this study

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.

Conditions

  • Rectocele
  • Enterocele
  • Rectal Prolapse

Interventions

DEVICE

Ifabond (Péters surgical)

Ifabond (Péters surgical) is a CE-marked synthetic surgical glue for internal and external use. The glue is non-toxic, biocompatible and biodegradable. It is commercially available and can be used for mesh fixation, as tissue adhesive, for sealing of sutured tissue and for hemostasis.

Sponsors & Collaborators

  • Duomed

    lead INDUSTRY

Principal Investigators

  • Anne Dams, MD · Ziekenhuis Oost-Limburg (ZOL)

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-08
Primary Completion
2025-11-30
Completion
2025-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04564677 on ClinicalTrials.gov