Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement

Completed

• Conditions: Rectal Cancer
• Interventions: Device: Strattice

• Registration Number: NCT01670851
• Lead Sponsor: University Hospitals, Leicester

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.

Study Timeline

• Study First Submitted: 2012-08-19
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-22
• Study Start: 2013-03
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-07
• Last Update Posted: 2015-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Strattice	Strattice	eLAPE

Primary Outcome Measures

Name	Time	Method
Perineal wound healing	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of parastomal hernia	24 months	Stoma will be assessed for herniation at Months 3, 6, 12 and 24
Incidence of perineal herniation	24 months	Incidence of perineal hernia

Trial Locations

Locations (3)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

University Hospitals Leicester; 🇬🇧 Leicester, United Kingdom

Slagelse Hospital; 🇩🇰 Slagelse, Denmark