%0 Journal Article
%T 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
%A J£¿rgen Ruteg£¿rd
%A Markku M Haapam£¿ki
%A Martin Ruteg£¿rd
%J -
%D 2019
%R 10.1136/bmjopen-2018-027255
%X 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 Ume£¿ University (protocol no: NEAPE-2010-335-31M). The results will be disseminated through patient associations and conventional scientific channels.

Trial registration number [NCT01347697][1]; Pre-results.

 [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01347697&atom=%2Fbmjopen%2F9%2F5%2Fe027255.ato
%U https://bmjopen.bmj.com/content/9/5/e027255