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

NCT01347697 | Completed DMC

• 1 other identifier: NEAPE-2010-335-31M
• Study Type: interventional
• Target: 91
• Locations: 2 countries
• Sites: 8

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.

Conditions

Rectal Cancer; Defect of Floor of Lesser Pelvis

Keywords

rectal neoplasms; reconstructive surgical procedure; bioprosthesis; surgical flaps; locomotion; lesser pelvis

Outcome Measures

Primary Outcomes (1)

• Performance in Timed-Stands Test

  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.

  6 months after surgery

Secondary Outcomes (13)

• Change in physical performance

  3, 6 and 12 months after surgery compared with preoperative results

• Primary wound healing assessed with the Southampton Wound Assessment Scale

  3 months from operation

• Complications according to classification by Dindo-Clavien

  3, 6 and 12 months after surgery

• Proportion of persistent perineal sinus or fistula

  3, 6 and 12 months after surgery

• Ability to sit

  3, 6 and 12 months after surgery

Study Arms (2)

Porcine collagen implant (biological mesh)

EXPERIMENTAL

Reconstruction with an acellular porcine dermal collagen implant (biological mesh).

Procedure: Reconstruction with an acellular porcine dermal collagen implant (biological mesh)

Gluteus maximus flap

ACTIVE COMPARATOR

Reconstruction with a gluteus maximus myocutaneous flap.

Procedure: Reconstruction with a gluteus maximus myocutaneous flap

Interventions

Reconstruction with an acellular porcine dermal collagen implant (biological mesh) PROCEDURE

Reconstruction of floor of lesser pelvis with an acellular porcine dermal collagen implant (biological mesh) after extended excision of rectum including levator muscles in advanced low rectal cancer.

Porcine collagen implant (biological mesh)

Reconstruction with a gluteus maximus myocutaneous flap PROCEDURE

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.

Gluteus maximus flap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead
• The Swedish Society of Medicine: collaborator
• Västerbotten County Council, Sweden: collaborator

Study Sites (8)

Oulu University Hospital

Oulu, Finland

Location

Sunderby County Hospital

Luleå, 971 80, Sweden

Location

Skåne Universtiy Hospital

Malmo, 20502, Sweden

Location

Östersund Hospital

Östersund, 831 83, Sweden

Location

Karolinska University Hospital, Solna

Stockholm, 171 76, Sweden

Location

Umeå University Hospital, Department of Surgical and Perioperative Sciences

Umeå, 901 85, Sweden

Location

Uppsala University Hospital

Uppsala, 751 85, Sweden

Location

Västmanlands Sjukhus Västerås

Västerås, 72189, Sweden

Location

Related Publications (3)

• 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.

  PMID: 17143848 BACKGROUND

• 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.

  PMID: 21160320 BACKGROUND

• 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.

  PMID: 31147361 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Markku M Haapamäki, MD, PhD

  Umeå University, Department of Surgical and Perioperative Sciences

  PRINCIPAL INVESTIGATOR

• Jörgen Rutegård, MD, PhD

  Umeå University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2011
• First Posted: May 4, 2011
• Study Start: September 5, 2011
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

FI (1); SE (7)