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NCT01670851 Clinical Trial

Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement

Rectal Cancer Clinical Trial

— PRESSUR  

Official title:
Perineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01670851
Other study ID # ISIS.11.01.06.BS/SC
Secondary ID
Status Completed
Phase N/A
First received August 19, 2012
Last updated December 7, 2015
Start date March 2013
Est. completion date September 2015

Study information
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

Clinical Trial 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.

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.

Recruitment information / eligibility
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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Strattice
Perineal reconstruction and stoma reinforcement with Strattice

Locations
Country Name City State
Denmark Slagelse Hospital Slagelse
Sweden Karolinska University Hospital Stockholm
United Kingdom University Hospitals Leicester Leicester

Sponsors (4)
Lead Sponsor Collaborator
University Hospitals, Leicester Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Karolinska University Hospital, Slagelse Hospital

Countries where clinical trial is conducted

Denmark,  Sweden,  United Kingdom, 

Outcome
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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