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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
14
Parietene Macro is used on retromuscular sublay position. The bowel is brought through opening in the middle of the mesh.
Parietex Parastomal is used on intraperitoneal onlay position by modified Sugarbaker technique to prevent parastomal hernia.
Dynamesh IPST is used on intraperitoneal onlay position to prevent parastomal hernia
Helsinki University Hospital
Helsinki, Finland
Jyväskylä Central Hospital
Jyväskylä, Finland
Oulu University Hospital
Oulu, Finland
Seinäjoki Central Hospital
Seinäjoki, Finland
Incidence of parastomal hernia
The primary outcome is incidence of parastomal hernia at 12 months follow up, detected clinically or on CT scan.
Time frame: 1 year
Surgical infections
Surgical infections due to primary surgery, defined by CDC (Centers for Disease Control) definition for surgical site infection.
Time frame: 30 days
Complications
The incidence of complications defined by Clavien-Dindo Classification
Time frame: 30 days
Stoma related complications
Any complications related to stoma
Time frame: 5 years
Reoperation rate
Reoperation needed for any reason related to previous surgery
Time frame: 5 years
Operative time
Total time needed in operation theatre and time needed for mesh application
Time frame: 30 days
Length of stay
Length of stay at the hospital.
Time frame: 30 days
Quality of Life measured by RAND 36
Quality of life measured by The RAND 36-Item Health Survey 1.0 which assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions with a scale 0-100, higher the score, better the quality of life.
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Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Time frame: 5 years