NCT03527784

Prestoma-Trial for Parastomal Hernia Prevention

PRESTOMA- A Prospective Randomized Controlled Multicenter Trial Comparing Three Meshes for Prevention of Parastomal Hernia After Abdominoperineal Resection for Rectal Adenocarcinoma

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Adenocarcinoma

Interventions

Type	Name	Description
DEVICE	Parietene Macro	Parietene Macro is used on retromuscular sublay position. The bowel is brought through opening in the middle of the mesh.
DEVICE	Parietex Parastomal	Parietex Parastomal is used on intraperitoneal onlay position by modified Sugarbaker technique to prevent parastomal hernia.
DEVICE	Dynamesh IPST	Dynamesh IPST is used on intraperitoneal onlay position to prevent parastomal hernia

Timeline

• Start date: 2018-05-03
• Primary completion: 2018-10-29
• Completion: 2018-10-29
• First posted: 2018-05-17
• Last updated: 2018-11-05

Locations

6 sites across 1 country: Finland