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Chimney Trial of Parastomal Hernia Prevention

Primary Purpose

Parastomal Hernia, Rectal Adenocarcinoma, Abdominoperineal Resection

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Intervention group
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parastomal Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University Hospital
  • Keski-Suomi Central Hospital
  • Oulu University Hospital
  • Seinäjoki Central Hospital
  • Tampere University Hospital
  • Turku University Hospital
  • Maziar Nikberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

Participants in control group are operated with no preventive mesh.

Outcomes

Primary Outcome Measures

Incidence of parastomal hernia
Incidence of parastomal hernia at 12 months follow up

Secondary Outcome Measures

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

Full Information

First Posted
January 6, 2019
Last Updated
August 10, 2021
Sponsor
University of Oulu
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1. Study Identification

Unique Protocol Identification Number
NCT03799939
Brief Title
Chimney Trial of Parastomal Hernia Prevention
Official Title
Chimney Trial - Randomized, Controlled, Multi Center Trial of Parastomal Hernia Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parastomal Hernia, Rectal Adenocarcinoma, Abdominoperineal Resection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Chimney trial is a prospective randomized controlled multicenter trial.
Masking
Participant
Masking Description
Participants are unaware of the randomization group.
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in control group are operated with no preventive mesh.
Intervention Type
Device
Intervention Name(s)
Intervention group
Intervention Description
Polyvinylidene fluoride mesh (Dynamesh IPST) is used on intraperitoneal onlay position to prevent parastomal hernia.
Primary Outcome Measure Information:
Title
Incidence of parastomal hernia
Description
Incidence of parastomal hernia at 12 months follow up
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence of parastomal hernia at long term follow up
Description
Incidence of parastomal hernia during 5 years of follow up
Time Frame
5 years
Title
Surgical site infection rate
Description
Surgical site infections measured by Clavien-Dindo Classification
Time Frame
30 days
Title
Complications
Description
Complications measured by Clavien-Dindo Classification
Time Frame
30 days
Title
Stoma related complications
Description
Stoma related complications measured by Clavien-Dindo Classification
Time Frame
5 years
Title
Reoperation rate
Description
Need for reoperations
Time Frame
5 years
Title
Operative time
Description
Operative time
Time Frame
1 day
Title
Length of stay
Description
Length of stay at the hospital
Time Frame
30 days
Title
Rand 36 quality of life
Description
Quality of life measured by Rand-36 quality of life questionnaire
Time Frame
5 years
Title
Quality of life measured by Colostomy impact score
Description
Quality of life measured by Colostomy impact score
Time Frame
5 years
Title
Medico-economic substudy
Description
Medico-economic substudy including both short and long term costs included in both groups
Time Frame
5 years
Title
Radiological substudy of stoma distance
Description
Distance of stoma from midline defined by umbilicus
Time Frame
3 years
Title
Radiological substudy of adipose tissue thickness
Description
Thickness of adipose tissue on computer tomography scan on contralateral site of stoma
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisa Mäkäräinen-Uhlbäck, M.D.
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
Keski-Suomi Central Hospital
City
Jyväskylä
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Facility Name
Seinäjoki Central Hospital
City
Seinäjoki
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Turku University Hospital
City
Turku
Country
Finland
Facility Name
Maziar Nikberg
City
Västerås
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31779699
Citation
Makarainen-Uhlback E, Wiik H, Kossi J, Nikberg M, Ohtonen P, Rautio T. Chimney Trial: study protocol for a randomized controlled trial. Trials. 2019 Nov 28;20(1):652. doi: 10.1186/s13063-019-3764-y.
Results Reference
derived

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Chimney Trial of Parastomal Hernia Prevention

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