Status:
ACTIVE_NOT_RECRUITING
PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
Lead Sponsor:
University of Oulu
Conditions:
Rectum Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.
Detailed Description
Incisional hernia after loop-ileostomy closure may be an underestimated problem. Research on both biological and synthetic mesh in this context is scarce and no randomized controlled trials comparing ...
Eligibility Criteria
Inclusion
- Anterior resection and TME with temporary loop-ileostomy for rectal carcinoma
- 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
- Patient with a comorbid illness or condition that would precluded 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 imposed a multi-organ resection
- Patient undergone emergency procedures
- Primary rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
- Metastatic disease with life expectancy of less than 12 months
- Pregnancy or suspected pregnancy
Key Trial Info
Start Date :
February 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03445936
Start Date
February 13 2018
End Date
October 1 2027
Last Update
February 1 2024
Active Locations (4)
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1
Jyvaskyla Central Hospital
Jyväskylä, Finland
2
Oulu University Hospital
Oulu, Finland
3
Seinajoki Central Hospital
Seinäjoki, Finland
4
Tampere University Hospital
Tampere, Finland