Clinical trial NCT01347697: Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer
Official title: Nordic Extended Abdominoperineal Excision (NEAPE) Study, a RCT Comparing a Porcine Acellular Dermal Collagen Implant (Biological Mesh) With a Gluteus Maximus Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Defect of Floor of Lesser Pelvis
Keywords: rectal neoplasms
reconstructive surgical procedure
bioprosthesis
surgical flaps
locomotion
lesser pelvis
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: The Swedish Society of Medicine
name: Västerbotten County Council, Sweden
First posted: 2011-05-04
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial compares two different techniques for reconstruction of the lesser pelvic floor after an extended abdominoperineal excision for locally advanced rectal cancer. The alternative reconstruction techniques in the trial are:

* a technique using a gluteus maximus myocutaneous flap or
* a technique using an acellular porcine collagen implant (biological mesh)

The primary endpoint will be physical performance six months from operation and our hypothesis is that the technique using an acellular porcine implant will cause less impaired physical performance compared to the technique using a myocutaneous flap.

The study is interventional, randomized and by definition a comparative effectiveness research project.

Detailed description: 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 (biological mesh) 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.

Eligibility criteria: Inclusion Criteria:

* Adult (18 years or older) rectal cancer patients where wide resection of pelvic floor muscles together with rectum and anal canal have made reconstruction of pelvic floor necessary i.e. primary suture of pelvic floor in the midline is not possible. Resection of coccyx is optional.

Exclusion Criteria:

* Age less than 18 years
* Very large resections including partial resection of sacrum and patients considered for bilateral flap reconstruction
* Large concomitant resection of vaginal wall where total (vaginal) wound closure is not an option
* Expected survival less than one year at operation
* Patient do not sign informed consent document

Primary outcomes:
measure: Performance in Timed-Stands Test
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Change in physical performance
timeFrame: 3, 6 and 12 months after surgery compared with preoperative results
measure: Primary wound healing assessed with the Southampton Wound Assessment Scale
timeFrame: 3 months from operation
measure: Complications according to classification by Dindo-Clavien
timeFrame: 3, 6 and 12 months after surgery
measure: Proportion of persistent perineal sinus or fistula
timeFrame: 3, 6 and 12 months after surgery
measure: Ability to sit
timeFrame: 3, 6 and 12 months after surgery
measure: Change of pain and discomfort in gluteal region measured with VAS
timeFrame: 3, 6 and 12 months after surgery compared to preoperative
measure: Pain and discomfort in gluteal region, spot measures with VAS
timeFrame: 3, 6 and 12 months after surgery
measure: Change of quality of life measured with EQ-5D and EORTC forms C30 and CR29
timeFrame: 3, 6 and 12 months after surgery compared to preoperative
measure: Quality of life spot measures
timeFrame: 3, 6 and 12 months after surgery
measure: Length of hospital stay
timeFrame: Six months after surgery
measure: Costs of surgical treatment
timeFrame: 12 months after surgery
measure: Quality-adjusted life years (QALYs gained)
timeFrame: 12 months after surgery
measure: Local recurrence
timeFrame: Five years after surgery
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Luleå
country: Sweden
facility: Sunderby County Hospital
city: Malmö
country: Sweden
facility: Skåne Universtiy Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Solna
city: Umeå
country: Sweden
facility: Umeå University Hospital, Department of Surgical and Perioperative Sciences
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Västerås
country: Sweden
facility: Västmanlands Sjukhus Västerås
city: Östersund
country: Sweden
facility: Östersund Hospital
Study officials:
affiliation: Umeå University, Department of Surgical and Perioperative Sciences
name: Markku M Haapamäki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Umeå University
name: Jörgen Rutegård, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Holm T, Ljung A, Haggmark T, Jurell G, Lagergren J. Extended abdominoperineal resection with gluteus maximus flap reconstruction of the pelvic floor for rectal cancer. Br J Surg. 2007 Feb;94(2):232-8. doi: 10.1002/bjs.5489.
citation: Haapamaki MM, Pihlgren V, Lundberg O, Sandzen B, Rutegard J. Physical performance and quality of life after extended abdominoperineal excision of rectum and reconstruction of the pelvic floor with gluteus maximus flap. Dis Colon Rectum. 2011 Jan;54(1):101-6. doi: 10.1007/DCR.0b013e3181fce26e.
citation: Rutegard M, Rutegard J, Haapamaki MM. 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. BMJ Open. 2019 May 29;9(5):e027255. doi: 10.1136/bmjopen-2018-027255.