APEMESH II - Perineal Reconstruction

Last updated: January 31, 2024
Sponsor: University of Oulu
Overall Status: Completed

Phase

N/A

Condition

Rectal Cancer

Colorectal Cancer

Digestive System Neoplasms

Treatment

Gluteus plasty enhanced with Progrip self gripping mesh

Clinical Study ID

NCT04779125
115/2020
  • Ages > 18
  • All Genders

Study Summary

The objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-control setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Curative intent abdominoperineal resection and permanent colostomy

Exclusion

Exclusion Criteria:

  • Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4- 5)
  • Immunosupression (cortisone >10mg/day) or severe malnutrition (BMI <20)
  • Diabetes with 1 or more organ damage
  • Dialysis treatment
  • Hepatic cirrhosis Child-Bugh B-C
  • Potentially curable resection not possible
  • Patient undergoing emergency procedures
  • Metastatic disease
  • Vaginal resection, pelvic exenteration and sacrum resection
  • Vaginal perforation
  • Pelvic abscess or perforated tumor
  • Pregnant or suspected pregnancy

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Gluteus plasty enhanced with Progrip self gripping mesh
Phase:
Study Start date:
March 19, 2021
Estimated Completion Date:
March 01, 2022

Study Description

Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy seems to be a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity.

Connect with a study center

  • Oulu University Hospital

    Oulu,
    Finland

    Site Not Available

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