Back to resultsPrestoma-Trial for Parastomal Hernia Prevention
Primary Purpose
Rectal Adenocarcinoma
Status
Terminated
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Parietene Macro
Parietex Parastomal
Dynamesh IPST
Sponsored by
About this trial
This is an interventional prevention trial for Rectal Adenocarcinoma focused on measuring rectal adenocarcinoma, abdominoperineal resection, hernia prophylaxis
Eligibility Criteria
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
Sites / Locations
- Helsinki University Hospital
- Jyväskylä Central Hospital
- Oulu University Hospital
- Seinäjoki Central Hospital
- Tampere University Hospital
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Parietene Macro
Parietex Parastomal
Dynamesh IPST
Arm Description
Parietene Macro is a macroporous synthetic mesh.
Parietex Parastomal is a synthetic mesh with resorbable collagen lining to prevent attachments.
Dynamesh IPST is synthetic mesh with central tube to accommodate bowel tightly designed to prevent and treat parastomal hernia.
Outcomes
Primary Outcome Measures
Incidence of parastomal hernia
The primary outcome is incidence of parastomal hernia at 12 months follow up, detected clinically or on CT scan.
Secondary Outcome Measures
Surgical infections
Surgical infections due to primary surgery, defined by CDC (Centers for Disease Control) definition for surgical site infection.
Complications
The incidence of complications defined by Clavien-Dindo Classification
Stoma related complications
Any complications related to stoma
Reoperation rate
Reoperation needed for any reason related to previous surgery
Operative time
Total time needed in operation theatre and time needed for mesh application
Length of stay
Length of stay at the hospital.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03527784
Brief Title
Prestoma-Trial for Parastomal Hernia Prevention
Official Title
PRESTOMA- A Prospective Randomized Controlled Multicenter Trial Comparing Three Meshes for Prevention of Parastomal Hernia After Abdominoperineal Resection for Rectal Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Parastomal Parietex withdrawn from market by the manufacturer.
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
October 29, 2018 (Actual)
Study Completion Date
October 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Adenocarcinoma
Keywords
rectal adenocarcinoma, abdominoperineal resection, hernia prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prestoma is a prospective randomized controlled multicenter trial.
Masking
Participant
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.
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parietene Macro
Arm Type
Active Comparator
Arm Description
Parietene Macro is a macroporous synthetic mesh.
Arm Title
Parietex Parastomal
Arm Type
Active Comparator
Arm Description
Parietex Parastomal is a synthetic mesh with resorbable collagen lining to prevent attachments.
Arm Title
Dynamesh IPST
Arm Type
Active Comparator
Arm Description
Dynamesh IPST is synthetic mesh with central tube to accommodate bowel tightly designed to prevent and treat parastomal hernia.
Intervention Type
Device
Intervention Name(s)
Parietene Macro
Intervention Description
Parietene Macro is used on retromuscular sublay position. The bowel is brought through opening in the middle of the mesh.
Intervention Type
Device
Intervention Name(s)
Parietex Parastomal
Intervention Description
Parietex Parastomal is used on intraperitoneal onlay position by modified Sugarbaker technique to prevent parastomal hernia.
Intervention Type
Device
Intervention Name(s)
Dynamesh IPST
Intervention Description
Dynamesh IPST is used on intraperitoneal onlay position to prevent parastomal hernia
Primary Outcome Measure Information:
Title
Incidence of parastomal hernia
Description
The primary outcome is incidence of parastomal hernia at 12 months follow up, detected clinically or on CT scan.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Surgical infections
Description
Surgical infections due to primary surgery, defined by CDC (Centers for Disease Control) definition for surgical site infection.
Time Frame
30 days
Title
Complications
Description
The incidence of complications defined by Clavien-Dindo Classification
Time Frame
30 days
Title
Stoma related complications
Description
Any complications related to stoma
Time Frame
5 years
Title
Reoperation rate
Description
Reoperation needed for any reason related to previous surgery
Time Frame
5 years
Title
Operative time
Description
Total time needed in operation theatre and time needed for mesh application
Time Frame
30 days
Title
Length of stay
Description
Length of stay at the hospital.
Time Frame
30 days
Title
Quality of Life measured by RAND 36
Description
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.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisa Mäkäräinen-Uhlbäck, M.D.
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
Jyväskylä Central Hospital
City
Jyväskylä
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Facility Name
Seinäjoki Central Hospital
City
Seinäjoki
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Turku University Hospital
City
Turku
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
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Prestoma-Trial for Parastomal Hernia Prevention
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