Chimney Trial of Parastomal Hernia Prevention

Not Applicable

Active, not recruiting

• Conditions: Abdominoperineal Resection; Parastomal Hernia; Rectal Adenocarcinoma
• Interventions: Device: Intervention group

• Registration Number: NCT03799939
• Lead Sponsor: University of Oulu

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.

Study Timeline

• Study First Submitted: 2019-01-06
• Study First Submitted QC: 2019-01-08
• Study First Posted: 2019-01-10
• Study Start: 2019-02-05
• Primary Completion: 2022-08-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 141

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	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.

Primary Outcome Measures

Name	Time	Method
Incidence of parastomal hernia	12 months	Incidence of parastomal hernia at 12 months follow up

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Keski-Suomi Central Hospital; 🇫🇮 Jyväskylä, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Turku University Hospital; 🇫🇮 Turku, Finland

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Seinäjoki Central Hospital; 🇫🇮 Seinäjoki, Finland

Maziar Nikberg; 🇸🇪 Västerås, Sweden

Tampere University Hospital; 🇫🇮 Tampere, Finland