PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Oulu
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- Incisional hernia
Study Overview
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 meshes exist.
The aim of this study is to compare Parietene Macro and Permacol in prevention of incisional site hernia after temporary loop-ileostomy reversal after anterior resection and TME for rectal cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Subject is blinded of the mesh used. Outcome at 10 month follow-up is assessed by surgeon who was not involved in the operation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Parietene Macro
Parietene Macro is a macroporous synthetic mesh used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.
Intervention: Parietene Macro (Device)
Permacol
Permacol is a acellular porcine dermal implant used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure.
Intervention: Permacol (Device)
Outcomes
Primary Outcomes
Incisional hernia
Time Frame: 10 months
Incidence of incisional hernia
Surgical site infection
Time Frame: 30 days
The incidence of surgical site infections at 30 days follow up
Secondary Outcomes
- Operative time(30 days)
- Incidence of hernia(5 years)
- Cost analysis(5 years)
- Complications classified by Clavien-Dindo classification(30 days)
- Re-operation rate(5 years)
- Length of stay(30 days)
- Quality of life measured by RAND-36 survey(5 years)
Investigators
Elisa Mäkäräinen
MD
University of Oulu