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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| Slagelse Hospital | OTHER |
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This is a prospective, multicenter, single arm, observational pilot study to assess the clinical outcomes of Strattice Reconstructive Tissue Matrix for perineal reconstruction following eLAPE and simultaneous stoma reinforcement.
About 40 subjects will be enrolled from 4 centers over approx 24 months. Subjects will all be undergoing extralevator abdominoperineal excision with concomitant ostomy creation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strattice | eLAPE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strattice | Device | Perineal reconstruction and stoma reinforcement with Strattice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perineal wound healing | Perineal wound healing will be assessed using the Southamptom Wound Scoring System and perineal pain assessed using a visual analogue scale (VAS) daily during hospital stay and then POD 7, 30 and months 3, 6 and 12. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of perineal herniation | Incidence of perineal hernia | 24 months |
| Incidence of parastomal hernia | Stoma will be assessed for herniation at Months 3, 6, 12 and 24 |
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Inclusion Criteria:
Exclusion Criteria:
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patients with low rectal carcinoma
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| Name | Affiliation | Role |
|---|---|---|
| Baljit Singh, FRCS, FACS | University Hospital Leicester, UK | Principal Investigator |
| Sanjay Chaudhri, FRCS | University Hospital Leicester, UK | Principal Investigator |
| Per J Nilsson, MD | Karolinska Institutet | Principal Investigator |
| Pierre J Maina, MD | Slagelse Hospital, Denmark | Principal Investigator |
| W Bemelman, MD | Academic Medical Center, Amsterdam, Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Slagelse Hospital | Slagelse | Denmark | ||||
| Karolinska University Hospital |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 24 months |
| Stockholm |
| Sweden |
| University Hospitals Leicester | Leicester | LE5 4PW | United Kingdom |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |