Collagen Implant Compared to Gluteus Maximus Flap for Reconstruction of Pelvic Floor After ELAPE/EAPE in Rectal Cancer (NEAPE)
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
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.
|Rectal Cancer Defect of Floor of Lesser Pelvis||Procedure: Reconstruction with an acellular porcine collagen implant Procedure: Reconstruction with a gluteus maximus myocutaneous flap||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- Performance in Timed-Stands Test [ Time Frame: 6 months after surgery ]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 ]Change in Timed-Stands Test performance
- Primary wound healing assessed with the Southampton Wound Assessment Scale [ Time Frame: 3 months from operation ]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 ]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 ]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 ]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 ]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 ]EQ-5D and EORTC are validated quality of life instruments
- Quality of life spot measures [ Time Frame: 3, 6 and 12 months after surgery ]Quality of life at specified time points
- Length of hospital stay, costs of surgical treatments and QALYs gained [ Time Frame: one year after surgery ]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.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
Experimental: Porcine collagen implant
Reconstruction with an acellular porcine collagen implant.
Procedure: Reconstruction with an acellular porcine collagen implant
Reconstruction of floor of lesser pelvis with an acellular porcine collagen implant after extended excision of rectum including levator muscles in advanced low rectal cancer.
Active Comparator: Gluteus maximus flap
Reconstruction with a gluteus maximus myocutaneous flap.
Procedure: Reconstruction with a gluteus maximus myocutaneous flap
Reconstruction of floor of lesser pelvis with an gluteus maximus myocutaneous flap after extended excision of rectum including levator muscles in advanced low 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:
- the operative technique is standardized according to the study protocol
- the centre/unit has resources for examinations of participants by a physiotherapist or a nurse
- the centre/unit has one investigator in charge of the study locally
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347697
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347697
|Contact: Marja-Liisa Lammi-Tavelin, B.Sc.||+email@example.com|
|Contact: Markku M Haapamäki, MD, PhDfirstname.lastname@example.org|
|Oulu University Hospital||Recruiting|
|Contact: Tero Rautio, MD, PhD +358-8-3152817 email@example.com|
|Principal Investigator: Tero Rautio, MD, PhD|
|Sunderby County Hospital||Recruiting|
|Luleå, Sweden, 971 80|
|Contact: Michael Dahlberg, MD, PhD +46-920 282000 firstname.lastname@example.org|
|Principal Investigator: Michael Dahlberg, MD, PhD|
|Skåne Universtiy Hospital||Recruiting|
|Malmö, Sweden, 20502|
|Contact: Marie-Louise Lydrup, MD, PhD +46-76-8890091 email@example.com|
|Principal Investigator: Marie-Louise Lydrup, MD, PhD|
|Karolinska University Hospital, Solna||Recruiting|
|Stockholm, Sweden, 171 76|
|Contact: Anna Martling, MD, PhD +46-8-51772802 firstname.lastname@example.org|
|Principal Investigator: Anna Martling, MD, PhD|
|Umeå University Hospital, Department of Surgical and Perioperative Sciences||Recruiting|
|Umeå, Sweden, 901 85|
|Contact: Marja-Liisa Lammi-Tavelin, B.Sc. +46-70-2012764 email@example.com|
|Contact: Markku M Haapamäki, MD, PhD +46-90-7851221 firstname.lastname@example.org|
|Principal Investigator: Markku M Haapamäki, MD, PhD|
|Uppsala University Hospital||Recruiting|
|Uppsala, Sweden, 751 85|
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|Contact: Helgi Birgisson, MD, PhD Helgi Birgisson <Helgi.Birgisson@surgsci.uu.se>|
|Principal Investigator: Lars Påhlman, MD, PhD|
|Sub-Investigator: Helgi Birgisson, MD, PhD|
|Västmanlands Sjukhus Västerås||Recruiting|
|Västerås, Sweden, 72189|
|Contact: Kenneth Smedh, MD, PhD +46-70-3735576 firstname.lastname@example.org|
|Contact: Maziar Nikberg, MD, PhD 070-4185721 email@example.com|
|Principal Investigator: Keneth Smedh, MD, PhD|
|Östersund, Sweden, 831 83|
|Contact: Pär Nordin, MD, PhD +46-63-153000 firstname.lastname@example.org|
|Principal Investigator: Pär Nordin, MD, PhD|
|Principal Investigator:||Markku M Haapamäki, MD, PhD||Umeå University, Department of Surgical and Perioperative Sciences|
|Study Director:||Jörgen Rutegård, MD, PhD||Umeå University|