Status:
ACTIVE_NOT_RECRUITING
Chimney Trial of Parastomal Hernia Prevention
Lead Sponsor:
University of Oulu
Conditions:
Parastomal Hernia
Rectal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT03799939
Start Date
February 5 2019
End Date
July 1 2026
Last Update
February 1 2024
Active Locations (7)
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1
Helsinki University Hospital
Helsinki, Finland
2
Keski-Suomi Central Hospital
Jyväskylä, Finland
3
Oulu University Hospital
Oulu, Finland
4
Seinäjoki Central Hospital
Seinäjoki, Finland