Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Defect of Floor of Lesser Pelvis | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reconstruction with a gluteus maximus myocutaneous flap | Procedure | — | UNRESOLVED |
| Reconstruction with an acellular porcine dermal collagen implant (biological mesh) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Porcine collagen implant (biological mesh)
- description
- Reconstruction with an acellular porcine dermal collagen implant (biological mesh).
- interventionNames
- Procedure: Reconstruction with an acellular porcine dermal collagen implant (biological mesh)
- type
- ACTIVE_COMPARATOR
- label
- Gluteus maximus flap
- description
- Reconstruction with a gluteus maximus myocutaneous flap.
- interventionNames
- Procedure: Reconstruction with a gluteus maximus myocutaneous flap
Primary outcomes (1)
- measure
- Performance in Timed-Stands Test
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Age less than 18 years * 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 * Expected survival less than one year at operation * Patient do not sign informed consent document
References
Publications (4)
- BACKGROUNDHolm T, Ljung A, Haggmark T, Jurell G, Lagergren J. Extended abdominoperineal resection with gluteus maximus flap reconstruction of the pelvic floor for rectal cancer. Br J Surg. 2007 Feb;94(2):232-8. doi: 10.1002/bjs.5489. PMID 17143848
- BACKGROUNDHaapamaki MM, Pihlgren V, Lundberg O, Sandzen B, Rutegard J. Physical performance and quality of life after extended abdominoperineal excision of rectum and reconstruction of the pelvic floor with gluteus maximus flap. Dis Colon Rectum. 2011 Jan;54(1):101-6. doi: 10.1007/DCR.0b013e3181fce26e. PMID 21160320
- DERIVEDRutegard M, Svensson J, Rutegard J, Rautio T, Nilsson PJ, Sjostrom O, Lydrup ML, Odensten C, Soderstrom A, Dahlberg M, Haapamaki MM. Collagen implant versus gluteus maximus flap for perineal closure after extended abdominoperineal excision: NEAPE randomized clinical trial. BJS Open. 2026 May 12;10(3):zrag079. doi: 10.1093/bjsopen/zrag079. PMID 42341212
- DERIVEDRutegard M, Rutegard J, Haapamaki MM. Multicentre, randomised trial comparing acellular porcine collagen implant versus gluteus maximus myocutaneous flap for reconstruction of the pelvic floor after extended abdominoperineal excision of rectum: study protocol for the Nordic Extended Abdominoperineal Excision (NEAPE) study. BMJ Open. 2019 May 29;9(5):e027255. doi: 10.1136/bmjopen-2018-027255. PMID 31147361