Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
14 participants
INTERVENTIONAL
2018-05-03
2018-10-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Parietene Macro
Parietene Macro is a macroporous synthetic mesh.
Parietene Macro
Parietene Macro is used on retromuscular sublay position. The bowel is brought through opening in the middle of the mesh.
Parietex Parastomal
Parietex Parastomal is a synthetic mesh with resorbable collagen lining to prevent attachments.
Parietex Parastomal
Parietex Parastomal is used on intraperitoneal onlay position by modified Sugarbaker technique to prevent parastomal hernia.
Dynamesh IPST
Dynamesh IPST is synthetic mesh with central tube to accommodate bowel tightly designed to prevent and treat parastomal hernia.
Dynamesh IPST
Dynamesh IPST is used on intraperitoneal onlay position to prevent parastomal hernia
Interventions
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Parietene Macro
Parietene Macro is used on retromuscular sublay position. The bowel is brought through opening in the middle of the mesh.
Parietex Parastomal
Parietex Parastomal is used on intraperitoneal onlay position by modified Sugarbaker technique to prevent parastomal hernia.
Dynamesh IPST
Dynamesh IPST is used on intraperitoneal onlay position to prevent parastomal hernia
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Oulu
OTHER
Responsible Party
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Elisa Makarainen-Uhlback
M.D.
Principal Investigators
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Elisa Mäkäräinen-Uhlbäck, M.D.
Role: PRINCIPAL_INVESTIGATOR
Oulu University Hospital
Locations
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Helsinki University Hospital
Helsinki, , Finland
Jyväskylä Central Hospital
Jyväskylä, , Finland
Oulu University Hospital
Oulu, , Finland
Seinäjoki Central Hospital
Seinäjoki, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Countries
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Other Identifiers
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85/2018
Identifier Type: -
Identifier Source: org_study_id
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