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

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.

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