Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement (PRESSUR)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Perineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement|
- Perineal wound healing [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]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.
- Incidence of perineal herniation [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Incidence of perineal hernia
- Incidence of parastomal hernia [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Stoma will be assessed for herniation at Months 3, 6, 12 and 24
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Perineal reconstruction and stoma reinforcement with Strattice
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.
|Slagelse Hospital||Not yet recruiting|
|Academic Medical Centre||Not yet recruiting|
|Karolinska University Hospital||Not yet recruiting|
|University Hospitals Leicester||Not yet recruiting|
|Leicester, United Kingdom, LE5 4PW|
|Contact: Baljit Singh, FRCS, FACS|
|Principal Investigator:||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|