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.
Study Type
OBSERVATIONAL
Enrollment
20
Perineal reconstruction and stoma reinforcement with Strattice
Slagelse Hospital
Slagelse, Denmark
Karolinska University Hospital
Stockholm, Sweden
University Hospitals Leicester
Leicester, United Kingdom
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.
Time frame: 12 months
Incidence of perineal herniation
Incidence of perineal hernia
Time frame: 24 months
Incidence of parastomal hernia
Stoma will be assessed for herniation at Months 3, 6, 12 and 24
Time frame: 24 months
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