Rectal Cancer Clinical Trial
— PRESSUROfficial title:
Perineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement
Verified date | December 2015 |
Source | University Hospitals, Leicester |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: National Health Service |
Study type | Observational |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Primary cancers undergoing curative surgery (R0) - Life expectancy > 2 yrs - Neoadjuvant radiotherapy with or without chemotherapy Exclusion Criteria: - Pelvic extenteration or extended resections - Previously irradiated patients (i.e. radiation therapy for a previous cancer) - Co-morbidities of: systemic infection, chronic liver failure, chronic renal failure, HIV, Hepatitis C, other advanced/metastatic cancer, collagen disorder - sensitivity to porcine derived products or polysorbate |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Denmark | Slagelse Hospital | Slagelse | |
Sweden | Karolinska University Hospital | Stockholm | |
United Kingdom | University Hospitals Leicester | Leicester |
Lead Sponsor | Collaborator |
---|---|
University Hospitals, Leicester | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Karolinska University Hospital, Slagelse Hospital |
Denmark, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | Incidence of perineal herniation | Incidence of perineal hernia | 24 months | Yes |
Secondary | Incidence of parastomal hernia | Stoma will be assessed for herniation at Months 3, 6, 12 and 24 | 24 months | Yes |
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