Reinforcement of Closure of Stoma Site

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02238964
• Date of registration: 10/09/2014
• Prospective Registration: No
• Primary sponsor: University of Birmingham
• Public title: Reinforcement of Closure of Stoma Site ROCSS
• Scientific title: A Randomised Controlled Trial of Reinforcement of Closure of Stoma Site Using a Biological Mesh.
• Date of first enrolment: November 2012
• Target sample size: 790
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02238964
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Denmark, Netherlands, United Kingdom

Contacts

• Name: Dion G Morton, MD
• Affiliation: Professor of Colorectal Surgery

Key inclusion & exclusion criteria

Inclusion Criteria:

- Require an elective closure of an ileostomy or a colostomy.

- Able and willing to provide written informed consent.

- Aged 18 years or over.

Exclusion Criteria:

- Taking part in another clinical study which is related to the surgical procedure.

- Allergic to any porcine or collagen products.

- History of familial adenomatous polyposis, due to increased risk of desmoid tumours.

- The surgeon determines that a mesh repair will definitely be required e.g. due to
large parastomal hernia.

- Unable or unwilling to provide written informed consent.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hernia

Intervention(s)

Device: Strattice™ Reconstructive Tissue Matrix

Procedure: Standard Closure

Primary Outcome(s)

Rate of clinically detectable hernias at two years post-randomisation. [Time Frame: Two years post-randomisation.]

Secondary Outcome(s)

Two-year and long-term costs per additional quality adjusted life (QALY) year gained. [Time Frame: Two-year post-randomisation]

Quality of life assessed using EuroQol EQ-5D at baseline, 30 days post-operatively, 12 and 24 months post-randomisation. [Time Frame: Baseline, 30 days post-operatively, one and two years post-randomisation]

Pain assessed using a 100 point visual analogue scale at baseline, 30 days postoperatively, 12 and 24 months post-randomisation. [Time Frame: Baseline, 30 days post-operatively, one and two years post-randomisation]

Incidence of developing a symptomatic hernia evaluated at 12 and 24 months postrandomisation. [Time Frame: One and two years post-randomisation.]

Surgical complications, including wound infections and seroma formation, at 30 days postoperatively and at 1 year post-randomisation. [Time Frame: 30 days postoperatively, 1 year post randomisation]

Surgical re-intervention rates at 2 years post-randomisation. [Time Frame: Two years post-randomisation.]

Costs per hernia clinically detected at 2 years post-randomisation. [Time Frame: Two years post-randomisation.]

Radiological hernia rate at one year post-randomisation. [Time Frame: One year post-randomisation.]

Secondary ID(s)

RG_11-186

13461

12/WM/0187

46330337

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

LifeCell