Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

Collagen implant versus gluteus maximus flap for perineal closure after extended abdominoperineal excision : NEAPE randomized clinical trial

Rutegård, Martin ; Svensson, Johan ; Rutegård, Jörgen ; Rautio, Tero ; Nilsson, Per J. ; Sjöström, Olle ; Lydrup, Marie Louise LU ; Odensten, Christoffer ; Söderström, Andreas and Dahlberg, Michael , et al. (2026) In BJS Open 10(3).
Abstract

Background: Optimal reconstruction of the perineal defect after extended abdominoperineal excision remains uncertain, and randomized comparisons between biological mesh and myocutaneous flaps are lacking. This trial assessed whether an acellular porcine collagen implant (APCI) is non-inferior to a gluteus maximus myocutaneous flap (GMF) for pelvic floor reconstruction. Methods: NEAPE was a multicentre, randomized, non-inferiority trial conducted in eight Nordic referral centres. Adults undergoing extended abdominoperineal excision for rectal cancer were randomized to reconstruction with an APCI or unilateral GMF. The primary outcome was the proportion of patients underperforming in the timed-stands test at 6 months, defined relative to... (More)

Background: Optimal reconstruction of the perineal defect after extended abdominoperineal excision remains uncertain, and randomized comparisons between biological mesh and myocutaneous flaps are lacking. This trial assessed whether an acellular porcine collagen implant (APCI) is non-inferior to a gluteus maximus myocutaneous flap (GMF) for pelvic floor reconstruction. Methods: NEAPE was a multicentre, randomized, non-inferiority trial conducted in eight Nordic referral centres. Adults undergoing extended abdominoperineal excision for rectal cancer were randomized to reconstruction with an APCI or unilateral GMF. The primary outcome was the proportion of patients underperforming in the timed-stands test at 6 months, defined relative to age- and sex-matched reference values. The non-inferiority margin was −10%. Results: Eighty-three patients were included in the modified intention-to-treat population (mean(standard deviation) age 68(10) years; 31% female). At 6 months, 71% of patients (25 of 35) in the implant group and 60% of patients (20 of 33) in the flap group underperformed. The risk difference was −11% (one-sided 95% confidence interval −30% to ∞), and non-inferiority was not demonstrated. Conclusion: The APCI did not demonstrate non-inferiority compared with the GMF. The direction of the effect favoured the flap, with results compatible with worse functional outcomes in the implant group. Registration number: ClinicalTrials.gov NCT01347697.

(Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and , et al. (More)
; ; ; ; ; ; ; ; ; and (Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
extralevator abdominoperineal excision, neoplasm of rectum, postoperative disability, reconstructive procedures, rectal cancer
in
BJS Open
volume
10
issue
3
article number
zrag079
publisher
Wiley
external identifiers
  • pmid:42341212
  • scopus:105042632636
ISSN
2474-9842
DOI
10.1093/bjsopen/zrag079
language
English
LU publication?
yes
id
2acdc0aa-fab3-4e1a-ac7c-b91fa9a14a9c
date added to LUP
2026-07-03 10:28:46
date last changed
2026-07-04 03:00:07
@article{2acdc0aa-fab3-4e1a-ac7c-b91fa9a14a9c,
  abstract     = {{<p>Background: Optimal reconstruction of the perineal defect after extended abdominoperineal excision remains uncertain, and randomized comparisons between biological mesh and myocutaneous flaps are lacking. This trial assessed whether an acellular porcine collagen implant (APCI) is non-inferior to a gluteus maximus myocutaneous flap (GMF) for pelvic floor reconstruction. Methods: NEAPE was a multicentre, randomized, non-inferiority trial conducted in eight Nordic referral centres. Adults undergoing extended abdominoperineal excision for rectal cancer were randomized to reconstruction with an APCI or unilateral GMF. The primary outcome was the proportion of patients underperforming in the timed-stands test at 6 months, defined relative to age- and sex-matched reference values. The non-inferiority margin was −10%. Results: Eighty-three patients were included in the modified intention-to-treat population (mean(standard deviation) age 68(10) years; 31% female). At 6 months, 71% of patients (25 of 35) in the implant group and 60% of patients (20 of 33) in the flap group underperformed. The risk difference was −11% (one-sided 95% confidence interval −30% to ∞), and non-inferiority was not demonstrated. Conclusion: The APCI did not demonstrate non-inferiority compared with the GMF. The direction of the effect favoured the flap, with results compatible with worse functional outcomes in the implant group. Registration number: ClinicalTrials.gov NCT01347697.</p>}},
  author       = {{Rutegård, Martin and Svensson, Johan and Rutegård, Jörgen and Rautio, Tero and Nilsson, Per J. and Sjöström, Olle and Lydrup, Marie Louise and Odensten, Christoffer and Söderström, Andreas and Dahlberg, Michael and Haapamäki, Markku M.}},
  issn         = {{2474-9842}},
  keywords     = {{extralevator abdominoperineal excision; neoplasm of rectum; postoperative disability; reconstructive procedures; rectal cancer}},
  language     = {{eng}},
  number       = {{3}},
  publisher    = {{Wiley}},
  series       = {{BJS Open}},
  title        = {{Collagen implant versus gluteus maximus flap for perineal closure after extended abdominoperineal excision : NEAPE randomized clinical trial}},
  url          = {{http://dx.doi.org/10.1093/bjsopen/zrag079}},
  doi          = {{10.1093/bjsopen/zrag079}},
  volume       = {{10}},
  year         = {{2026}},
}