Trials / Unknown
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
| Type | Name | Description |
|---|---|---|
| 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. |
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.