MedTrace Logo

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

NCT01347697 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-10-03

No results posted yet for this study

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

Interventions

PROCEDURE

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

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.

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.

Sponsors & Collaborators

  • The Swedish Society of Medicine

    collaborator OTHER

  • Västerbotten County Council, Sweden

    collaborator OTHER_GOV

  • Umeå University

    lead OTHER

Principal Investigators

  • Markku M Haapamäki, MD, PhD · Umeå University, Department of Surgical and Perioperative Sciences

  • Jörgen Rutegård, MD, PhD · Umeå University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-05
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Finland
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01347697 on ClinicalTrials.gov