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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2011 by Umeå University
Sponsor:
Collaborators:
The Swedish Society of Medicine
The County Council of Vasterbotten
Information provided by:
Umeå University
ClinicalTrials.gov Identifier:
NCT01347697
First received: May 3, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Defect of Floor of Lesser Pelvis
Procedure: Reconstruction of floor of lesser pelvis with an acellular porcine collagen implant
Procedure: Reconstruction of floor of lesser pelvis with a gluteus maximus flap
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 108
Study Start Date: May 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Porcine collagen implant
Patients who have the floor of lesser pelvis reconstructed with an acellular porcine collagen implant.
Procedure: Reconstruction of floor of lesser pelvis 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
Patients who have the floor of lesser pelvis reconstructed with a gluteus maximus myocutaneous flap.
Procedure: Reconstruction of floor of lesser pelvis with a gluteus maximus 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.

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 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347697

Contacts
Contact: Kerstin M Granberg, B.Sc. +46-90-7858039 kerstin.m.granberg@vll.se
Contact: Markku M Haapamäki, MD, PhD +46-90-7852013 markku.haapamaki@surgery.umu.se

Locations
Sweden
Sunderby County Hospital Recruiting
Luleå, Sweden, 971 80
Contact: Michael Dahlberg, MD, PhD    +46-920 282000    michael.dahlberg@nll.se   
Principal Investigator: Michael Dahlberg, MD, PhD         
Karolinska University Hospital, Solna Recruiting
Stockholm, Sweden, 171 76
Contact: Anna Martling, MD, PhD    +46-8-51772802    anna.martling@karolinska.se   
Principal Investigator: Anna Martling, MD, PhD         
Umeå University Hospital Recruiting
Umeå, Sweden, 901 85
Contact: Kerstin M Granberg, B.Sc.    +46-90-785 8039    kerstin.m.granberg@vll.se   
Contact: Markku M Haapamäki, MD, PhD    +46-90-7852013    markku.haapamaki@surgery.umu.se   
Principal Investigator: Markku M Haapamäki, MD, PhD         
Sub-Investigator: Jesper Näsström, MD         
Uppsala University Hospital Recruiting
Uppsala, Sweden, 751 85
Contact: Lars Påhlman, MD, PhD    +46-18-6110000    lars.pahlman@surgsci.uu.se   
Principal Investigator: Lars Påhlman, MD, PhD         
Östersund Hospital Recruiting
Östersund, Sweden, 831 83
Contact: Pär Nordin, MD, PhD    +46-63-153000    par.nordin@jll.se   
Principal Investigator: Pär Nordin, MD, PhD         
Sponsors and Collaborators
Umeå University
The Swedish Society of Medicine
The County Council of Vasterbotten
Investigators
Principal Investigator: Markku M Haapamäki, MD, PhD Umeå University
Study Chair: Peter Naredi, MD, PhD Umeå University
Study Director: Jörgen Rutegård, MD, PhD Umeå University
  More Information

Publications:
Responsible Party: Torbjörn Myrnäs, Head of Department, Department of Surgery, Umeå University Hospital, County Council of Västerbotten
ClinicalTrials.gov Identifier: NCT01347697     History of Changes
Other Study ID Numbers: NEAPE-2010-335-31M
Study First Received: May 3, 2011
Last Updated: May 3, 2011
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Umeå University:
rectal neoplasms
reconstructive surgical procedure
bioprosthesis
surgical flaps
locomotion
lesser pelvis

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 22, 2014