Prestoma-Trial for Parastomal Hernia Prevention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rectal Adenocarcinoma

Intervention / Treatment
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* Device: Parietene Macro
* Device: Parietex Parastomal
* Device: Dynamesh IPST


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prestoma is a prospective randomized controlled multicenter trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Parietene Macro<br>Parietene Macro is a macroporous synthetic mesh. | Device: Parietene Macro<br>* Parietene Macro is used on retromuscular sublay position. The bowel is brought through opening in the middle of the mesh.<br>|
| Active Comparator: Parietex Parastomal<br>Parietex Parastomal is a synthetic mesh with resorbable collagen lining to prevent attachments. | Device: Parietex Parastomal<br>* Parietex Parastomal is used on intraperitoneal onlay position by modified Sugarbaker technique to prevent parastomal hernia.<br>|
| Active Comparator: Dynamesh IPST<br>Dynamesh IPST is synthetic mesh with central tube to accommodate bowel tightly designed to prevent and treat parastomal hernia. | Device: Dynamesh IPST<br>* Dynamesh IPST is used on intraperitoneal onlay position to prevent parastomal hernia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of parastomal hernia | The primary outcome is incidence of parastomal hernia at 12 months follow up, detected clinically or on CT scan. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical infections | Surgical infections due to primary surgery, defined by CDC (Centers for Disease Control) definition for surgical site infection. | 30 days | 
| Complications | The incidence of complications defined by Clavien-Dindo Classification | 30 days | 
| Stoma related complications | Any complications related to stoma | 5 years | 
| Reoperation rate | Reoperation needed for any reason related to previous surgery | 5 years | 
| Operative time | Total time needed in operation theatre and time needed for mesh application | 30 days | 
| Length of stay | Length of stay at the hospital. | 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. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominoperineal resection, hernia prophylaxis, rectal adenocarcinoma