Rectal Adenocarcinoma
Conditions
Keywords
rectal adenocarcinoma, abdominoperineal resection, hernia prophylaxis
Brief 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.
Interventions
DEVICEParietene Macro
Parietene Macro is used on retromuscular sublay position. The bowel is brought through opening in the middle of the mesh.
DEVICEParietex Parastomal
Parietex Parastomal is used on intraperitoneal onlay position by modified Sugarbaker technique to prevent parastomal hernia.
DEVICEDynamesh IPST
Dynamesh IPST is used on intraperitoneal onlay position to prevent parastomal hernia
Sponsors
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Subject is blinded of the mesh used. Outcome at 12 month follow-up is assessed by surgeon who was not involved in the operation.
Intervention model description
Prestoma is a prospective randomized controlled multicenter trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of parastomal hernia | 1 year | The primary outcome is incidence of parastomal hernia at 12 months follow up, detected clinically or on CT scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 30 days | The incidence of complications defined by Clavien-Dindo Classification |
| Stoma related complications | 5 years | Any complications related to stoma |
| Reoperation rate | 5 years | Reoperation needed for any reason related to previous surgery |
| Surgical infections | 30 days | Surgical infections due to primary surgery, defined by CDC (Centers for Disease Control) definition for surgical site infection. |
| Length of stay | 30 days | Length of stay at the hospital. |
| Quality of Life measured by RAND 36 | 5 years | 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. |
| Operative time | 30 days | Total time needed in operation theatre and time needed for mesh application |
Countries
Finland
Outcome results
None listed