Reinforcement of closure of stoma site using a biological mesh

A randomised controlled trial of Reinforcement Of Closure of Stoma Site using a biological mesh

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN46330337

Enrollment

790

Registered

2012-11-30

Start date

2012-11-20

Completion date

Unknown

Last updated

2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Oral and Gastrointestinal, Generic Health Relevance and Cross Cutting Themes

Interventions

Reinforcement of the stoma closure site using the Strattice® collagen mesh.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients to be included in the study must: 1. Require an elective closure of stoma site 2. Have given written informed consent 3. Male & Female, aged 18 or over 4. Agree to the randomised procedure

Exclusion criteria

Exclusion criteria: 1. Patients taking part in another clinical study which directly relates to the surgical procedure 2. Allergic to any porcine or collagen products 3. Unable or unwilling to provide written informed consent Added 03/06/2015: 4. History of familial adenomatous polyposis, due to increased risk of desmoid tumours 5. The surgeon determines that a mesh repair will definitely be required e.g. due to large parastomal hernia

Design outcomes

Primary

Measure	Time frame
Recruitment at 12 months Added 03/06/2015: Full phase III: Rate of clinically detectable hernias at two years post-randomisation.	—

Secondary

Measure	Time frame
Added 03/06/2015: Full phase III: 1. Radiological hernia rate at 1 year post-randomisation. An exploratory analysis will also compare radiological hernia rate at 1 year with clinical hernia rate at 2 years to assess the value of using a CT scan as an early diagnostic tool of incisional hernias 2. Incidence of developing a symptomatic hernia evaluated at 12 and 24 months post-randomisation. The clinical detection of hernias defined by palpable fascial defects, and global weaknesses around closed stoma sites without palpable fascial defects, will be recorded. Patient-reported hernia symptoms including a local lump or pain at the site of the stoma closure will also be collected 3. Surgical re-intervention rates at 2 years post-randomisation 4. Surgical complications, including wound infections and seroma formation, at 30 days post-operatively and at 1 year post-randomisation 5. Quality of life assessed using EuroQol EQ-5D at baseline, 30 days post-operatively, 12 and 24 months post-randomisation 6. Pain assessed using a 100-point visual analogue scale at baseline, 30 days post-operatively, 12 and 24 months post-randomisation Added 10/01/2017: 7. Costs per hernia clinically detected at 2 years post-randomisation 8. Two-year and long-term costs per additional quality adjusted life (QALY) year gained	—

Measure

Time frame

Added 03/06/2015: Full phase III: 1. Radiological hernia rate at 1 year post-randomisation. An exploratory analysis will also compare radiological hernia rate at 1 year with clinical hernia rate at 2 years to assess the value of using a CT scan as an early diagnostic tool of incisional hernias 2. Incidence of developing a symptomatic hernia evaluated at 12 and 24 months post-randomisation. The clinical detection of hernias defined by palpable fascial defects, and global weaknesses around closed stoma sites without palpable fascial defects, will be recorded. Patient-reported hernia symptoms including a local lump or pain at the site of the stoma closure will also be collected 3. Surgical re-intervention rates at 2 years post-randomisation 4. Surgical complications, including wound infections and seroma formation, at 30 days post-operatively and at 1 year post-randomisation 5. Quality of life assessed using EuroQol EQ-5D at baseline, 30 days post-operatively, 12 and 24 months post-randomisation 6. Pain assessed using a 100-point visual analogue scale at baseline, 30 days post-operatively, 12 and 24 months post-randomisation Added 10/01/2017: 7. Costs per hernia clinically detected at 2 years post-randomisation 8. Two-year and long-term costs per additional quality adjusted life (QALY) year gained

—

Countries

Denmark, Netherlands, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026