Trial Information

Nordic Extended Abdominoperineal Excision (NEAPE) Study, a Randomized Clinical Trial Comparing a Collagen Implant With a Gluteus Maximus Flap for Reconstruction of Pelvic Floor After Extended Abdominoperineal Excision of Rectum in Rectal Cancer

Extended abdominoperineal excision (EAPE) of the rectum is the potentially curative
operation for rectal carcinomas too low for primary anastomosis, especially if the levator
and sphincter musculature is infiltrated. This enlarged operation, when the levator
musculature is excised en bloc with the rectum, creates a large defect. Primary closure is
often not possible, and reconstruction with prosthetic material or a myocutaneous flap is
necessary to avoid a perineal hernia. Implantation of a collagen sheet has shown preliminary
good results and on the other hand, the use of a gluteus myocutaneous flap is routine in
many clinics. There is a lack of scientific evidence to prove which method is better for the
reconstruction of the lesser pelvic floor.

The current study aims to compare the two reconstruction techniques.

Centres that treat locally advanced rectal cancers with the extended abdominoperineal
excision of rectum (EAPE)[Holm et al 2007] can participate provided that:

1. the operative technique is standardized according to the study protocol

2. the centre/unit has resources for examinations of participants by a physiotherapist or
a nurse

3. the centre/unit has one investigator in charge of the study locally

4. the centre/unit has an operative volume that enables at least 6 patients to be
included/randomised during the anticipated three year study phase for inclusions

Centres that do not operate the rectal cancers included in this study can participate by
arranging the preoperative examination and physical tests as well as follow-up of patients
that are referred to other centres for the operation. In these cases the operating centre
cares for the randomisation, operation and start of postoperative rehabilitation while the
study follow-up and final rehabilitation can be completed at the patients' primary referral
hospital. The primary referral hospital needs a site investigator in charge of study
patients just like centres that do the operations.

Patients with primary or recurrent cancers of rectal origin can be included but individual
patients can be included only once. Concomitant therapies are allowed and preoperative or
postoperative radiation therapy and/or chemotherapy may be given or not according to local
multidisciplinary team (MDT) decisions.