Skip to main content
OpenTrials
Completed

NCT Number: NCT04334421

APEMESH- Preventing Perineal Complications After Abdominoperineal Resection

Abdominoperineal resection leaves an empty space to be filled by mesh or musculocutaneus flap. Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy is a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity. The role of omentoplasty at APR is controversial.

Previous studies on synthetic mesh repair on perineum are almost lacking.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rectal Cancer Abdominoperineal Resection Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Wound Heal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oulu University Hospital

Oulu, Finland

About this study

The objective of this pilot study is to assess the feasibility and the potential benefits of synthetic mesh reconstruction in perineum in case-control setting.

30 subjects will be prospectively enrolled to this study as intervention group. Controls matched with age, gender and preoperative radiotherapy are selected from retrospective data collected from Oulu University database and operated for rectal adenocarcinoma 2009-2017 with otherwise identical methods.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Abdominoperineal resection and permanent colostoma

Exclusion criteria

  • Patient with a comorbid illness of condition that would preclude the use of surgery (ASA5)
  • Potentially curable resection not possible
  • Patient undergoing emergency procedure
  • Metastatic disease
  • Pregnant or suspected pregnancy

Treatment and study plan

Composite mesh

Device

Pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) to improve healing and prevent perineal herniation.

Primary outcomes

  1. Comprehensive Complication index

    Time frame: 30 days

    Comprehensive Complication index is used to evaluate outcome

Secondary outcomes

  1. Surgical site infection

    Time frame: 30 days

    Surgical site infection classified by Clavien-Dindo score

  2. Reoperation rate

    Time frame: 30 days

    Reoperations during primary stay at the hospital

  3. Operative time

    Time frame: 30 days

    Operative time

  4. Length of stay

    Time frame: 30 days

    Length of stay at the hospital during primary operation and recovery

  5. Costs

    Time frame: 30 days

    Costs by materials used

  6. Total perineal healing time

    Time frame: 30 days

    Time to point when perineum is closed and healed

  7. Perineal sinus

    Time frame: 30 days

    Presence of perineal sinus at 30 days follow-up

  8. Perineal hernia

    Time frame: 12 months

    Perineal hernia by CT scan at 12 months follow-up

Sponsors and collaborators

Lead sponsor

Elisa Mäkäräinen

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 6, 2020
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.