Chimney Trial of Parastomal Hernia Prevention

January 31, 2024 updated by: Elisa Mäkäräinen, University of Oulu

Chimney Trial - Randomized, Controlled, Multi Center Trial of Parastomal Hernia Prevention

Chimney trial is designed to compare the effectiveness and safety of specifically designated polyvinylidene fluoride mesh (PVDF, Dynamesh IPST) to controls in a multi center, randomized setting.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The European Hernia Society recommends the use of prophylactic mesh when permanent colostomy is made. The results of previous trials using keyhole technique are partially unsatisfactory. Specifically designed PVDF mesh used in this trial showed promising results in previous small trial.

Chimney trial is designed to compare the effectiveness and safety of mesh group to controls operated with no preventive mesh in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection or low Haartman's procedure for rectal adenocarcinoma.

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Not Applicable

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
      • Helsinki, Finland
        • Helsinki University Hospital
      • Jyväskylä, Finland
        • Keski-Suomi Central Hospital
      • Oulu, Finland
        • Oulu University Hospital
      • Seinäjoki, Finland
        • Seinäjoki Central Hospital
      • Tampere, Finland
        • Tampere University Hospital
      • Turku, Finland
        • Turku University Hospital
  • Sweden
      • Västerås, Sweden
        • Maziar Nikberg

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

Description

Inclusion Criteria:

  • 18 years or older
  • Rectal adenocarcinoma with curative intent laparoscopic or robotic assisted abdominoperineal resection or low Hartmann´s operation and permanent colostomy
  • Patient has a life expectancy of at least 12 months.
  • Patient must sign Informed consent before any study procedures and agrees to attend all study visits

Exclusion Criteria:

  • Abdominoperineal resection or Hartmann's operation by laparotomy or conversion to laparotomy
  • Complication requiring laparotomy during post surgery treatment at surgical ward after APR
  • Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4-5).
  • Patients with concurrent or previous malignant tumors within 5 years before study enrollment
  • Patients with T4b tumors which impose a multi-organ resection
  • Rectal malignancy other than adenocarcinoma
  • Patient undergoing emergency procedures
  • Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
  • Metastatic disease with no possibility of curative surgery
  • Pregnant or suspected pregnancy
  • Patients living geographically distant and/or unwilling to return for follow-ups or comply with all study requirements
  • Active abdominal infection at the time of surgery
  • Previous surgery at the colostomy site
  • Language barrier or other reasons why informed consent is not possible

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group
Polyvinylidene fluoride mesh used in this trial (Dynamesh IPST) is synthetic mesh with central tube to accommodate bowel tightly and designed to prevent and treat parastomal hernia.
Device: Intervention group
Polyvinylidene fluoride mesh (Dynamesh IPST) is used on intraperitoneal onlay position to prevent parastomal hernia.
No Intervention: Control group
Participants in control group are operated with no preventive mesh.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of parastomal hernia
Time Frame: 12 months
Incidence of parastomal hernia at 12 months follow up
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of parastomal hernia at long term follow up
Time Frame: 5 years
Incidence of parastomal hernia during 5 years of follow up
5 years
Surgical site infection rate
Time Frame: 30 days
Surgical site infections measured by Clavien-Dindo Classification
30 days
Complications
Time Frame: 30 days
Complications measured by Clavien-Dindo Classification
30 days
Stoma related complications
Time Frame: 5 years
Stoma related complications measured by Clavien-Dindo Classification
5 years
Reoperation rate
Time Frame: 5 years
Need for reoperations
5 years
Operative time
Time Frame: 1 day
Operative time
1 day
Length of stay
Time Frame: 30 days
Length of stay at the hospital
30 days
Rand 36 quality of life
Time Frame: 5 years
Quality of life measured by Rand-36 quality of life questionnaire
5 years
Quality of life measured by Colostomy impact score
Time Frame: 5 years
Quality of life measured by Colostomy impact score
5 years
Medico-economic substudy
Time Frame: 5 years
Medico-economic substudy including both short and long term costs included in both groups
5 years
Radiological substudy of stoma distance
Time Frame: 3 years
Distance of stoma from midline defined by umbilicus
3 years
Radiological substudy of adipose tissue thickness
Time Frame: 3 years
Thickness of adipose tissue on computer tomography scan on contralateral site of stoma
3 years

Collaborators and Investigators

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

Sponsor

University of Oulu

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 5, 2019

Primary Completion (Actual)

August 30, 2022

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 6, 2019

First Submitted That Met QC Criteria

January 8, 2019

First Posted (Actual)

January 10, 2019

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

  • 305/2018

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

product manufactured in and exported from the U.S.

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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