Chimney Trial of Parastomal Hernia Prevention

Rectal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03799939
• Other study ID #: 305/2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 5, 2019
• Est. completion date: July 2026

Study information

• Verified date: January 2024
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 141
• Est. completion date: July 2026
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominoperineal Resection
• Hernia
• Parastomal Hernia
• Rectal Adenocarcinoma

Intervention

Device:
• Intervention group
Polyvinylidene fluoride mesh (Dynamesh IPST) is used on intraperitoneal onlay position to prevent parastomal hernia.

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki
Finland	Keski-Suomi Central Hospital	Jyväskylä
Finland	Oulu University Hospital	Oulu
Finland	Seinäjoki Central Hospital	Seinäjoki
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku
Sweden	Maziar Nikberg	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Countries where clinical trial is conducted

Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of parastomal hernia	Incidence of parastomal hernia at 12 months follow up	12 months
Secondary	Incidence of parastomal hernia at long term follow up	Incidence of parastomal hernia during 5 years of follow up	5 years
Secondary	Surgical site infection rate	Surgical site infections measured by Clavien-Dindo Classification	30 days
Secondary	Complications	Complications measured by Clavien-Dindo Classification	30 days
Secondary	Stoma related complications	Stoma related complications measured by Clavien-Dindo Classification	5 years
Secondary	Reoperation rate	Need for reoperations	5 years
Secondary	Operative time	Operative time	1 day
Secondary	Length of stay	Length of stay at the hospital	30 days
Secondary	Rand 36 quality of life	Quality of life measured by Rand-36 quality of life questionnaire	5 years
Secondary	Quality of life measured by Colostomy impact score	Quality of life measured by Colostomy impact score	5 years
Secondary	Medico-economic substudy	Medico-economic substudy including both short and long term costs included in both groups	5 years
Secondary	Radiological substudy of stoma distance	Distance of stoma from midline defined by umbilicus	3 years
Secondary	Radiological substudy of adipose tissue thickness	Thickness of adipose tissue on computer tomography scan on contralateral site of stoma	3 years