Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement (PRESSUR)

NHS Trust

Status: Completed

Conditions: Rectal Cancer

Treatments: Device: Strattice

Study type: Observational

Funder types: Other

Identifiers

NCT01670851

ISIS.11.01.06.BS/SC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Strattice

Description:

eLAPE

Treatment:

Device: Strattice