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Brief Title: Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement
Official Title: Perineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement
Study ID: NCT01670851
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Slagelse Hospital, Slagelse, , Denmark
Karolinska University Hospital, Stockholm, , Sweden
University Hospitals Leicester, Leicester, , United Kingdom
Name: Baljit Singh, FRCS, FACS
Affiliation: University Hospital Leicester, UK
Role: PRINCIPAL_INVESTIGATOR
Name: Sanjay Chaudhri, FRCS
Affiliation: University Hospital Leicester, UK
Role: PRINCIPAL_INVESTIGATOR
Name: Per J Nilsson, MD
Affiliation: Karolinska Institutet
Role: PRINCIPAL_INVESTIGATOR
Name: Pierre J Maina, MD
Affiliation: Slagelse Hospital, Denmark
Role: PRINCIPAL_INVESTIGATOR
Name: W Bemelman, MD
Affiliation: Academic Medical Center, Amsterdam, Netherlands
Role: PRINCIPAL_INVESTIGATOR