Clinical trial NCT03527784: Prestoma-Trial for Parastomal Hernia Prevention
Official title: PRESTOMA- A Prospective Randomized Controlled Multicenter Trial Comparing Three Meshes for Prevention of Parastomal Hernia After Abdominoperineal Resection for Rectal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rectal Adenocarcinoma
Keywords: rectal adenocarcinoma
abdominoperineal resection
hernia prophylaxis
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prestoma is a prospective randomized controlled multicenter trial.
Primary purpose: PREVENTION

Brief summary: Prestoma Trial is designed to compare the safety and efficiency of three different meshes and techniques to prevent parastomal hernia after laparoscopic or robotic-assisted abdominoperineal resection for rectal adenocarcinoma.

Detailed description: Parastomal hernia after permanent colostomy formation is a common problem. The European Hernia Society recommends the use of prophylactic mesh when the stoma is constructed. So far, there're no trials comparing the methods to prevent the parastomal hernia.

Prestoma Trial is designed to compare the most researched retromuscular mesh (Parietene Macro by Medtronic) with two different types of intraperitoneal meshes (Parietex Parastomal by Medtronic and Dynamesh IPST) in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection for rectal adenocarcinoma.

Eligibility criteria: Inclusion Criteria:

* Abdominoperineal resection for rectal cancer with permanent end colostomy, either by laparoscopic technique or robotic assistance
* 18 years or older
* Patient has a life expectancy of at least 12 months.
* Patient signs the Informed consent and agrees to attend all study visits.

Exclusion Criteria:

* Abdominoperineal resection by laparotomy or conversion to laparotomy
* 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
* Potentially curable resection not possible
* Patient undergoing emergency procedures
* Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
* Metastatic disease with life expectancy of less than 1 year
* Pregnant or suspected pregnancy
* Patients living geographically distant and/or unwilling to return for follow-ups or comply with all study requirements

Primary outcomes:
measure: Incidence of parastomal hernia
timeFrame: 1 year
Secondary outcomes:
measure: Surgical infections
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: 30 days
measure: Length of stay
timeFrame: 30 days
measure: Quality of Life measured by RAND 36
timeFrame: 5 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Jyväskylä
country: Finland
facility: Jyväskylä 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
Study officials:
affiliation: Oulu University Hospital
name: Elisa Mäkäräinen-Uhlbäck, M.D.
role: PRINCIPAL_INVESTIGATOR
References: