APEMESH- Preventing Perineal Complications After Abdominoperineal Resection

January 31, 2024 updated by: Elisa Mäkäräinen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland
        • Oulu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All study patients who have abdominoperineal resection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mesh group
After resection, pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) and covered with subcutaneous flap.
Device: Composite mesh
Pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) to improve healing and prevent perineal herniation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comprehensive Complication index
Time Frame: 30 days
Comprehensive Complication index is used to evaluate outcome
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site infection
Time Frame: 30 days
Surgical site infection classified by Clavien-Dindo score
30 days
Reoperation rate
Time Frame: 30 days
Reoperations during primary stay at the hospital
30 days
Operative time
Time Frame: 30 days
Operative time
30 days
Length of stay
Time Frame: 30 days
Length of stay at the hospital during primary operation and recovery
30 days
Costs
Time Frame: 30 days
Costs by materials used
30 days
Total perineal healing time
Time Frame: 30 days
Time to point when perineum is closed and healed
30 days
Perineal sinus
Time Frame: 30 days
Presence of perineal sinus at 30 days follow-up
30 days
Perineal hernia
Time Frame: 12 months
Perineal hernia by CT scan at 12 months follow-up
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elisa Mäkäräinen

Investigators

  • Principal Investigator: Elisa Mäkäräinen-Uhlbäck, M.D., Oulu University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2020

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

April 1, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 6, 2020

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 57/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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