Clinical trial NCT03799939: Chimney Trial of Parastomal Hernia Prevention
Official title: Chimney Trial - Randomized, Controlled, Multi Center Trial of Parastomal Hernia Prevention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parastomal Hernia
Rectal Adenocarcinoma
Abdominoperineal Resection
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Chimney trial is a prospective randomized controlled multicenter trial.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of parastomal hernia
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of parastomal hernia at long term follow up
timeFrame: 5 years
measure: Surgical site infection rate
timeFrame: 30 days
measure: Complications
timeFrame: 30 days
measure: Stoma related complications
timeFrame: 5 years
measure: Reoperation rate
timeFrame: 5 years
measure: Operative time
timeFrame: 1 day
measure: Length of stay
timeFrame: 30 days
measure: Rand 36 quality of life
timeFrame: 5 years
measure: Quality of life measured by Colostomy impact score
timeFrame: 5 years
measure: Medico-economic substudy
timeFrame: 5 years
measure: Radiological substudy of stoma distance
timeFrame: 3 years
measure: Radiological substudy of adipose tissue thickness
timeFrame: 3 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Jyväskylä
country: Finland
facility: Keski-Suomi Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Seinäjoki
country: Finland
facility: Seinäjoki Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Västerås
country: Sweden
facility: Maziar Nikberg
Study officials:
affiliation: Oulu University Hospital
name: Elisa Mäkäräinen-Uhlbäck, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.