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Completed

NCT Number: NCT04779125

APEMESH II - Perineal Reconstruction

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital

Oulu, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Curative intent abdominoperineal resection and permanent colostomy

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

Treatment and study plan

Gluteus plasty enhanced with Progrip self gripping mesh

Procedure

Intervention group will be compared to historical patients in a case-control setting. Intervention group will have a mesh enhanced gluteus plasty made to reconstruct perineum after abdominoperineal resection.

Primary outcomes

  1. Complications

    Time frame: 30 days

    Comprehensive complication index

Secondary outcomes

  1. Surgical site infections

    Time frame: 30 days

    Surgical site infections

  2. Reoperation rate

    Time frame: 30 days

    Reoperation rate

  3. Operative time

    Time frame: 30 days

    Operative time to reconstruct perineum

  4. Length of hospital stay

    Time frame: 30 days

    Primary length of stay at the hospital

  5. Costs of treatment materials

    Time frame: 30 days

    Costs of treatment materials

  6. Total perineal healing time

    Time frame: 1 year

    Time from operation to complete perineal healing

  7. Perineal fistula

    Time frame: 30 days

    Perineal sinus or fistula

  8. Perineal hernia

    Time frame: 12 months

    Perineal hernia incidence

  9. Gluteus muscle function measured by time stands test

    Time frame: 12 months

    Gluteus muscle function measured by time stands test

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Official study title

Apemesh II - Perineal Reconstruction With Mesh Enhanced Gluteus Plasty

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2021
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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