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.
Trial registration number NCT01347697; Pre-results.
- rectal cancer
- postoperative disability
- physical function
- myocutaneous flap
- porcine implant
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Contributors MR revised the study protocol, advised on statistical analyses and provided critical review. JR collected advice from Swedish colorectal surgeons and assisted in the refinement of the study protocol and its implementation. MH initiated the study, developed its design and wrote the protocol.
Funding County Council ofVästerbotten, Sweden, Grant VLL-187711 and Grant VLL-226241 with atotal amount of 1100 000 SEK. Swedish Society ofMedicine, Grant SLS-97651 and Grant SLS-176651 with a total amount of185 000 SEK. Swedish Society for Colonand Rectal Surgeons, Grant for start-up with a total amount of 25 000SEK
Competing interests None declared.
Ethics approval The principal investigator has applied for ethical board review at the Regional Ethical Review Board at Umeå University. The study was approved on 7 December 2010 with registration number 2010-335-31M. The application covers all study sites in Sweden, but centres in other countries may have to apply separately according to local regulations.
Provenance and peer review Not commissioned; externally peer reviewed.
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