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Prestoma-Trial for Parastomal Hernia Prevention

NCT03527784 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-11-05

No results posted yet for this study

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.

Conditions

  • Rectal Adenocarcinoma

Interventions

DEVICE

Parietene Macro

Parietene Macro is used on retromuscular sublay position. The bowel is brought through opening in the middle of the mesh.

DEVICE

Parietex Parastomal

Parietex Parastomal is used on intraperitoneal onlay position by modified Sugarbaker technique to prevent parastomal hernia.

DEVICE

Dynamesh IPST

Dynamesh IPST is used on intraperitoneal onlay position to prevent parastomal hernia

Sponsors & Collaborators

  • University of Oulu

    lead OTHER

Principal Investigators

  • Elisa Mäkäräinen-Uhlbäck, M.D. · Oulu University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-03
Primary Completion
2018-10-29
Completion
2018-10-29

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03527784 on ClinicalTrials.gov