NCT01347697Completed
Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer
Nordic Extended Abdominoperineal Excision (NEAPE) Study, a RCT Comparing a Porcine Acellular Dermal Collagen Implant (Biological Mesh) With a Gluteus Maximus Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer
Source: ClinicalTrials.gov · Last updated 3 Oct 2025
Brief summary (registry, in English)
The trial compares two different techniques for reconstruction of the lesser pelvic floor after an extended abdominoperineal excision for locally advanced rectal cancer. The alternative reconstruction techniques in the trial are: * a technique using a gluteus maximus myocutaneous flap or * a technique using an acellular porcine collagen implant (biological mesh) The primary endpoint will be physical performance six months from operation and our hypothesis is that the technique using an acellular porcine implant will cause less impaired physical performance compared to the technique using a myocutaneous flap. The study is interventional, randomized and by definition a comparative effectiveness research project.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 91 (actual)
- First submitted
- 3 May 2011
- Start date
- 5 Sept 2011
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Umeå University
- Diseases
- Colorectal cancer
- NCT number
- NCT01347697
What you commit to
- Study type: Interventional
- Participants enrolled: 91
- From 5 Sept 2011 to the primary completion date, 30 Sept 2024
- 8 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Very large resections including partial resection of sacrum and patients considered for bilateral flap reconstruction
- Large concomitant resection of vaginal wall where total (vaginal) wound closure is not an option
Age
- Age less than 18 years
Other
- Expected survival less than one year at operation
- Patient do not sign informed consent document
Who the study is looking for
- Adult (18 years or older) rectal cancer patients where wide resection of pelvic floor muscles together with rectum and anal canal have made reconstruction of pelvic floor necessary i.e. primary suture of pelvic floor in the midline is not possible. Resection of coccyx is optional.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Unknown status |
| Sunderby County Hospital Coordinator of this site? Confirm its status | Luleå | Sweden | Unknown status |
| Skåne Universtiy Hospital Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
| Östersund Hospital Coordinator of this site? Confirm its status | Östersund | Sweden | Unknown status |
| Karolinska University Hospital, Solna Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Umeå University Hospital, Department of Surgical and Perioperative Sciences Coordinator of this site? Confirm its status | Umeå | Sweden | Unknown status |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Unknown status |
| Västmanlands Sjukhus Västerås Coordinator of this site? Confirm its status | Västerås | Sweden | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.