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Abdominoperineal resection leaves an empty space to be filled by mesh or musculocutaneus flap. Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy is a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity. The role of omentoplasty at APR is controversial.
Previous studies on synthetic mesh repair on perineum are almost lacking.
The objective of this pilot study is to assess the feasibility and the potential benefits of synthetic mesh reconstruction in perineum in case-control setting.
30 subjects will be prospectively enrolled to this study as intervention group. Controls matched with age, gender and preoperative radiotherapy are selected from retrospective data collected from Oulu University database and operated for rectal adenocarcinoma 2009-2017 with otherwise identical methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesh group | After resection, pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) and covered with subcutaneous flap. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Composite mesh | Device | Pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) to improve healing and prevent perineal herniation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comprehensive Complication index | Comprehensive Complication index is used to evaluate outcome | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection | Surgical site infection classified by Clavien-Dindo score | 30 days |
| Reoperation rate | Reoperations during primary stay at the hospital |
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Inclusion Criteria:
Exclusion Criteria:
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All study patients who have abdominoperineal resection
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| Name | Affiliation | Role |
|---|---|---|
| Elisa Mäkäräinen-Uhlbäck, M.D. | Oulu University Hospital | Principal Investigator |
| 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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| 30 days |
| Operative time | Operative time | 30 days |
| Length of stay | Length of stay at the hospital during primary operation and recovery | 30 days |
| Costs | Costs by materials used | 30 days |
| Total perineal healing time | Time to point when perineum is closed and healed | 30 days |
| Perineal sinus | Presence of perineal sinus at 30 days follow-up | 30 days |
| Perineal hernia | Perineal hernia by CT scan at 12 months follow-up | 12 months |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |