umu.sePublikationer
Ändra sökning
RefereraExporteraLänk till posten
Permanent länk

Direktlänk
Referera
Referensformat
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Annat format
Fler format
Språk
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Annat språk
Fler språk
Utmatningsformat
  • html
  • text
  • asciidoc
  • rtf
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
Umeå universitet, Medicinska fakulteten, Institutionen för kirurgisk och perioperativ vetenskap, Kirurgi. Umeå universitet, Medicinska fakulteten, Wallenberg centrum för molekylär medicin vid Umeå universitet (WCMM).ORCID-id: 0000-0002-0974-6373
Umeå universitet, Medicinska fakulteten, Institutionen för kirurgisk och perioperativ vetenskap, Kirurgi.
Umeå universitet, Medicinska fakulteten, Institutionen för kirurgisk och perioperativ vetenskap, Kirurgi.
2019 (Engelska)Ingår i: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 9, nr 5, artikel-id e027255Artikel i tidskrift (Refereegranskat) Published
Abstract [en]

Introduction: Different surgical techniques are used to cover the defect in the floor of the lesser pelvis after an ‘extralevator’ or ‘extended’ abdominoperineal excision for advanced rectal cancer. However, these operations are potentially mutilating, and the reconstruction method of the pelvic floor has been studied only sparsely. We aim to study whether a porcine-collagen implant is superior or equally beneficial to a gluteus maximus myocutaneous flap as a reconstruction method.

Methods and analysis: This is a multicentre non-blinded randomised controlled trial with the experimental arm using a porcine-collagen implant and the control arm using a gluteus maximus muscle and skin rotation flap. Considered for inclusion are patients with rectal cancer, who are operated on with a wide abdominoperineal rectal excision including most of the levator muscles and where the muscle remnants cannot be closed in the midline with sutures. Patients with a primary or recurrent rectal cancer with an estimated survival of more than a year are eligible. The randomisation is computer generated with a concealed sequence and stratified by participating hospital and preoperative radiotherapy regimen. The main outcome is physical performance 6 months after surgery measured with the timed-stands test. Secondary outcomes are perineal wound healing, surgical complications, quality of life, ability to sit and other outcomes measured at 3, 6 and 12 months after surgery. To be able to state experimental arm non-inferiority with a 10% margin of the primary outcome with 90% statistical power and assuming 10% attrition, we aim to enrol 85 patients from May 2011 onwards.

Ethics and dissemination: The study has been approved by the Regional Ethical Review board at Umeå University (protocol no: NEAPE-2010-335-31M). The results will be disseminated through patient associations and conventional scientific channels.

Ort, förlag, år, upplaga, sidor
BMJ Publishing Group Ltd, 2019. Vol. 9, nr 5, artikel-id e027255
Nationell ämneskategori
Kirurgi
Identifikatorer
URN: urn:nbn:se:umu:diva-161540DOI: 10.1136/bmjopen-2018-027255ISI: 000471192800261PubMedID: 31147361OAI: oai:DiVA.org:umu-161540DiVA, id: diva2:1336926
Forskningsfinansiär
Västerbottens läns landsting, VLL-187711Västerbottens läns landsting, VLL-226241Tillgänglig från: 2019-07-11 Skapad: 2019-07-11 Senast uppdaterad: 2019-07-11Bibliografiskt granskad

Open Access i DiVA

fulltext(1502 kB)30 nedladdningar
Filinformation
Filnamn FULLTEXT01.pdfFilstorlek 1502 kBChecksumma SHA-512
f2a448734fcb78792b3ec110e8d55065cdf257097fbe99a9200fda7a90c56b62f75722ae58a56e6e727e7dd1a312536cd1fa36aede9fcc0c4c3543a6e1c94df7
Typ fulltextMimetyp application/pdf

Övriga länkar

Förlagets fulltextPubMed

Personposter BETA

Rutegård, MartinRutegård, JörgenHaapamäki, Markku M

Sök vidare i DiVA

Av författaren/redaktören
Rutegård, MartinRutegård, JörgenHaapamäki, Markku M
Av organisationen
KirurgiWallenberg centrum för molekylär medicin vid Umeå universitet (WCMM)
I samma tidskrift
BMJ Open
Kirurgi

Sök vidare utanför DiVA

GoogleGoogle Scholar
Totalt: 30 nedladdningar
Antalet nedladdningar är summan av nedladdningar för alla fulltexter. Det kan inkludera t.ex tidigare versioner som nu inte längre är tillgängliga.

doi
pubmed
urn-nbn

Altmetricpoäng

doi
pubmed
urn-nbn
Totalt: 1113 träffar
RefereraExporteraLänk till posten
Permanent länk

Direktlänk
Referera
Referensformat
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Annat format
Fler format
Språk
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Annat språk
Fler språk
Utmatningsformat
  • html
  • text
  • asciidoc
  • rtf