Trials / Completed
CompletedNCT04779125
APEMESH II - Perineal Reconstruction
Apemesh II - Perineal Reconstruction With Mesh Enhanced Gluteus Plasty
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- University of Oulu · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-control setting.
Detailed description
Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy seems to be a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Gluteus plasty enhanced with Progrip self gripping mesh | Intervention group will be compared to historical patients in a case-control setting. Intervention group will have a mesh enhanced gluteus plasty made to reconstruct perineum after abdominoperineal resection. |
Timeline
- Start date
- 2021-03-19
- Primary completion
- 2022-03-01
- Completion
- 2022-03-01
- First posted
- 2021-03-03
- Last updated
- 2024-02-01
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT04779125. Inclusion in this directory is not an endorsement.