Prestoma-Trial for Parastomal Hernia Prevention

University of Oulu

Status: Terminated

Conditions: Rectal Adenocarcinoma

Treatments: Device: Parietene Macro; Device: Parietex Parastomal; Device: Dynamesh IPST

Study type: Interventional

Funder types: Other

Identifiers

NCT03527784

85/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 3 patient groups

Parietene Macro

Active Comparator group

Description:

Parietene Macro is a macroporous synthetic mesh.

Treatment:

Device: Parietene Macro

Parietex Parastomal

Active Comparator group

Description:

Parietex Parastomal is a synthetic mesh with resorbable collagen lining to prevent attachments.

Treatment:

Device: Parietex Parastomal

Dynamesh IPST

Active Comparator group

Description:

Dynamesh IPST is synthetic mesh with central tube to accommodate bowel tightly designed to prevent and treat parastomal hernia.

Treatment:

Device: Dynamesh IPST