Evidence map›Paper›PMID 42341212›Full record

Trial reportBJS open2026

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

Martin Rutegård, Johan Svensson, Jörgen Rutegård, Tero Rautio, Per J Nilsson, Olle Sjöström, Marie-Louise Lydrup, Christoffer Odensten, Andreas Söderström, Michael Dahlberg and 1 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BJS open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01347697 (Nordic Extended Abdominoperineal Excision), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01347697 nacompletednot on this map

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

TypeinterventionalSponsorUmeå UniversityRan2011 to 2024Enrolled91ConditionsRectal Cancer, Defect of Floor of Lesser PelvisArmsReconstruction with an acellular porcine dermal collagen implant (biological mesh), Reconstruction with a gluteus maximus myocutaneous flap
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Martin RutegårdDepartment of Diagnostics and Intervention, Surgery, Umeå University, Umeå, Sweden.ORCID 0000-0002-0974-6373
Johan SvenssonDepartment of Diagnostics and Intervention, Surgery, Umeå University, Umeå, Sweden.
Jörgen RutegårdDepartment of Diagnostics and Intervention, Surgery, Umeå University, Umeå, Sweden.
Tero RautioOulu University Hospital, Medical Research Centre Oulu, Oulu, Finland.
Per J NilssonDepartment of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
Olle SjöströmDepartment of Diagnostics and Intervention, Surgery, Umeå University, Umeå, Sweden.
Marie-Louise LydrupDepartment of Surgery, Skåne University Hospital, Malmö, Lund University, Lund, Sweden.
Christoffer OdenstenDepartment of Diagnostics and Intervention, Surgery, Umeå University, Umeå, Sweden.
Andreas SöderströmDepartment of Diagnostics and Intervention, Surgery, Umeå University, Umeå, Sweden.
Michael DahlbergDepartment of Diagnostics and Intervention, Surgery, Umeå University, Umeå, Sweden.
Markku M HaapamäkiDepartment of Diagnostics and Intervention, Surgery, Umeå University, Umeå, Sweden.

Funding

County Council of Västerbotten, Sweden VLL-187711County Council of Västerbotten, Sweden VLL-226241Swedish Society for Colon and Rectal SurgeonsSwedish Society of Medicine SLS-176651Swedish Society of Medicine SLS-97651
6 · The paper itself

Abstract

backgroundOptimal 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.

methodsNEAPE 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%.

resultsEighty-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.

conclusionThe 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.

Indexed as

CollagenMyocutaneous FlapPerineumPlastic Surgery ProceduresProctectomyRectal NeoplasmsAgedFemaleHumansMaleMiddle AgedSurgical FlapsTreatment OutcomeCollagenextralevator abdominoperineal excisionneoplasm of rectumpostoperative disabilityreconstructive proceduresrectal cancer

Identifiers

PMID42341212
PMCPMC13293247

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.