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The objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-control setting.
Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy seems to be a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gluteus plasty enhanced with Progrip self gripping mesh | Experimental | All study patietns will have a gluteus enhanced plasty after abdominoperineal reconstruction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gluteus plasty enhanced with Progrip self gripping mesh | Procedure | Intervention group will be compared to historical patients in a case-control setting. Intervention group will have a mesh enhanced gluteus plasty made to reconstruct perineum after abdominoperineal resection. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Comprehensive complication index | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infections | Surgical site infections | 30 days |
| Reoperation rate | Reoperation rate | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tero Rautio, M.D. Ph.D. | Oulu University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital | Oulu | Finland |
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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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All patients, who have an abdominoperineal reconstruction for rectal cancer, will have a mesh enhanced gluteus plasty. The patients will be compared to historical cohort.
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| Operative time | Operative time to reconstruct perineum | 30 days |
| Length of hospital stay | Primary length of stay at the hospital | 30 days |
| Costs of treatment materials | Costs of treatment materials | 30 days |
| Total perineal healing time | Time from operation to complete perineal healing | 1 year |
| Perineal fistula | Perineal sinus or fistula | 30 days |
| Perineal hernia | Perineal hernia incidence | 12 months |
| Gluteus muscle function measured by time stands test | Gluteus muscle function measured by time stands test | 12 months |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |