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This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parietene Macro | Active Comparator | Parietene Macro is a macroporous synthetic mesh used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure. |
|
| Permacol | Active Comparator | Permacol is a acellular porcine dermal implant used in retro muscular sublay position to prevent incisional hernia after loop-ileostomy closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parietene Macro | Device | Parietene Macro is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection | The incidence of surgical site infections at 30 days follow up | 30 days |
| Incisional hernia | Incidence of incisional hernia | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complications classified by Clavien-Dindo classification | Clavien-Dindo I-V complications at 30 days follow-up | 30 days |
| Re-operation rate | Demand for re-operations related to mesh or complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisa Mäkäräinen-Uhlbäck | Oulu University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jyvaskyla Central Hospital | Jyväskylä | Finland | ||||
| Oulu University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37944025 | Derived | Makarainen EJ, Wiik HT, Kossi JAO, Pinta TM, Mantymaki LJ, Mattila AK, Nikki MJ, Jarvinen JE, Ohtonen PP, Rautio TT. Prevention of incisional hernia with retrorectus synthetic mesh versus biological mesh following loop ileostomy closure (Preloop trial). Br J Surg. 2024 Jan 3;111(1):znad362. doi: 10.1093/bjs/znad362. |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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This is a prospective randomized controlled multicenter trial
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Subject is blinded of the mesh used. Outcome at 10 month follow-up is assessed by surgeon who was not involved in the operation.
| Permacol | Device | Permacol biologic implant is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia. |
|
| 5 years |
| Operative time | Time (min) needed for operation and application of mesh/implant | 30 days |
| Length of stay | Length of stay at the hospital after the operation | 30 days |
| Quality of life measured by RAND-36 survey | Quality of life after the operation measured by RAND 36 | 5 years |
| Incidence of hernia | Incidence of incisional hernia | 5 years |
| Cost analysis | Analysis of costs to both individual and community | 5 years |
| Oulu |
| Finland |
| Seinajoki Central Hospital | Seinäjoki | Finland |
| Tampere University Hospital | Tampere | Finland |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |