Rectum Cancer
Conditions
Keywords
loop-ileostomy reversal, hernia prevention
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.
Interventions
DEVICEParietene Macro
Parietene Macro is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.
DEVICEPermacol
Permacol biologic implant is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.
Sponsors
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, 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.
Intervention model description
This is a prospective randomized controlled multicenter trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection | 30 days | The incidence of surgical site infections at 30 days follow up |
| Incisional hernia | 10 months | Incidence of incisional hernia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | 30 days | Time (min) needed for operation and application of mesh/implant |
| Length of stay | 30 days | Length of stay at the hospital after the operation |
| Complications classified by Clavien-Dindo classification | 30 days | Clavien-Dindo I-V complications at 30 days follow-up |
| Incidence of hernia | 5 years | Incidence of incisional hernia |
| Cost analysis | 5 years | Analysis of costs to both individual and community |
| Quality of life measured by RAND-36 survey | 5 years | Quality of life after the operation measured by RAND 36 |
| Re-operation rate | 5 years | Demand for re-operations related to mesh or complications |
Countries
Finland
Outcome results
None listed