⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: 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 ID: NCT01347697

Study Description

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Oulu University Hospital, Oulu, , Finland

Sunderby County Hospital, Luleå, , Sweden

Skåne Universtiy Hospital, Malmö, , Sweden

Karolinska University Hospital, Solna, Stockholm, , Sweden

Umeå University Hospital, Department of Surgical and Perioperative Sciences, Umeå, , Sweden

Uppsala University Hospital, Uppsala, , Sweden

Västmanlands Sjukhus Västerås, Västerås, , Sweden

Östersund Hospital, Östersund, , Sweden

Contact Details

Name: Markku M Haapamäki, MD, PhD

Affiliation: Umeå University, Department of Surgical and Perioperative Sciences

Role: PRINCIPAL_INVESTIGATOR

Name: Jörgen Rutegård, MD, PhD

Affiliation: Umeå University

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: