A Comparative Effectiveness Study Between Two Methods of Reconstruction of Pelvic Floor After Rectal Excision in Advanced Rectal Cancer (NEAPE)

• Performance in Timed-Stands Test [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
  Timed-Stands test is a combined measure of physical performance depending on at least muscle strength, balance, tenderness of gluteal skin and muscles and co-ordination of motion.
  
  

• Change in physical performance [ Time Frame: 3, 6 and 12 months after surgery compared with preoperative results ] [ Designated as safety issue: No ]
  Change in Timed-Stands Test performance
  
  
• Primary wound healing assessed with the Southampton Wound Assessment Scale [ Time Frame: 3 months from operation ] [ Designated as safety issue: No ]
  The Southampton Wound Assessment Scale is a validated measure of wound healing after surgery.
  
  
• Complications according to classification by Dindo-Clavien [ Time Frame: 3, 6 and 12 months after surgery ] [ Designated as safety issue: Yes ]
  The Dindo-Clavien classification of surgical complications is a validated instrument.
  
  
• Proportion of persistent perineal sinus or fistula [ Time Frame: 3, 6 and 12 months after surgery ] [ Designated as safety issue: No ]
  Proportion of patients with the wound healing defect of all patients in the particular study arm
  
  
• Ability to sit [ Time Frame: 3, 6 and 12 months after surgery ] [ Designated as safety issue: No ]
  Ability to sit is graded with a scale in three degrees.
  
  
• Change of pain and discomfort in gluteal region measured with VAS [ Time Frame: 3, 6 and 12 months after surgery compared to preoperative ] [ Designated as safety issue: No ]
  A standard visual analogue scale (VAS) from 0-100 mm is used.
  
  
• Change of quality of life measured with EQ-5D and EORTC forms C30 and CR29 [ Time Frame: 3, 6 and 12 months after surgery compared to preoperative ] [ Designated as safety issue: No ]
  EQ-5D and EORTC are validated quality of life instruments
  
  
• Quality of life spot measures [ Time Frame: 3, 6 and 12 months after surgery ] [ Designated as safety issue: No ]
  Quality of life at specified time points
  
  
• Length of hospital stay, costs of surgical treatments and QALYs gained [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]
  Quality adjusted life year (QALY) is calculated using an quality of life utility index at repeated time points. The utility index is adjusted for the relevant background population.
  
  

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.