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UnknownNCT04564677

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

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

Status
Unknown
Phase
Study type
Observational
Enrollment
150 (estimated)
Sponsor
Duomed · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEIfabond (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.

Timeline

Start date
2021-02-08
Primary completion
2025-11-30
Completion
2025-12-31
First posted
2020-09-25
Last updated
2023-10-10

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT04564677. Inclusion in this directory is not an endorsement.