Reinforcement of Closure of Stoma Site

Hernia Clinical Trial

— ROCSS  

Official title:

A Randomised Controlled Trial of Reinforcement of Closure of Stoma Site Using a Biological Mesh.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238964
• Other study ID #: RG_11-186
• Secondary ID: 463303371346112/
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2012
• Est. completion date: May 18, 2018

Study information

• Verified date: October 2018
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

ROCSS is a randomised controlled trial of the placement of a biological mesh at the site of stoma closure. Our hypothesis is that reinforcing the stoma closure site with a collagen mesh (Strattice®) is superior to the standard technique in preventing herniation at 2 years.

Description:

Closure of complex and contaminated abdominal wounds is challenging and carries risks, including wound dehiscence and incisional hernias. Use of biological meshes in these situations may provide a safe method of reducing these complications, especially long-term incisional hernias. ROCSS will use stoma site closure as a model for biological mesh placement during any difficult contaminated abdominal wall closures.

Hernia at the site of stoma closure occurs in up to 30% of patients and is associated with adverse effects on quality of life. In up to 10% of cases, patients are submitted to complex re-operation which carries significant morbidity. Not all patients will report symptoms or undergo repair, as they do not wish to have a further major operation. Incisional hernias at the site of stomas closure form an important and well defined subgroup. If there is a measurable benefit from mesh insertion, elective use of a collagen mesh would warrant consideration in the closure of other difficult, contaminated abdominal wounds. This study will also provide useful information on the value of using a CT scan as an early diagnostic tool of herniation, which could then be used in future abdominal wall studies as a surrogate endpoint for clinical hernia.

ROCSS aims to assess whether a biological mesh (collagen tissue matrix) reduces the incidence of clinically detectable stoma closure site hernias at two years compared to standard closure techniques. The primary outcome is Occurrence of clinically detectable hernias at two years post randomisation. Other outcomes include surgical re-intervention rate, surgical complications at 30 days post-operation and 1 year post-randomisation, quality of life and post-operative pain, cost-benefit analysis and radiological hernia rate at one year post-randomisation (an exploratory analysis will 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).

Randomisation is 1:1 between Strattice® mesh vs. standard closure. The sample size for the trial is 560 (80% power, 10% dropout/crossover, 40% proportional reduction - 25% to 15%) and recruitment will be over 2 years from at least 30 centres. ROCSS will be a double blind (observer blind) randomised controlled trial with a CT scan at one year and clinical follow up at 2 years. Cost benefit analysis and quality of life analysis will be performed at 2 years. The sample size will be reviewed prior to reaching target and may be increased 790 (90% power, 20% dropout/crossover, 40% proportional reduction - 25% to 15%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 790
• Est. completion date: May 18, 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia

Intervention

Device:
• Strattice™ Reconstructive Tissue Matrix
The protocol preference is for the mesh to be placed intra-peritoneally fashion (i.e. below the peritoneum). Anchoring bites will be taken in four to six sites of peritoneum (e.g. using 2-0 PDS) and the mesh will be 'parachuted' into place. Once correctly placed, the fascia above will be closed using Prolene, PDS or Nylon (surgeon preference, but excluding Vicryl). Infiltration of up to 40ml 0.25% Marcaine for infiltration into the fascial layer is recommended. The remainder of the closure will be at the surgeon's discretion.

Procedure:
• Standard Closure
The non-intervention arm for fascial closure will be the preferred technique of the surgeon without mesh reinforcement. The fascia should be closed with Prolene, PDS or nylon sutures; Vicryl should not be used for the fascia. The remainder of the closure will be at the surgeon's discretion.

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Copenhagen
Netherlands	Academisch Medisch Centrum	Amsterdam
United Kingdom	Tameside General Hospital	Ashton-under-Lyne
United Kingdom	Royal United Hospital Bath	Bath
United Kingdom	Heart of England NHS Foundation Trust	Birmingham
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Sandwell General Hospital	Birmingham
United Kingdom	Pilgrim Hospital	Boston
United Kingdom	Bristol Royal Infirmary	Bristol
United Kingdom	Broomfield Hospital	Chelmsford
United Kingdom	St Peters Hospital	Chertsey
United Kingdom	Chesterfield Royal Hospital	Chesterfield
United Kingdom	Western Sussex Hospitals NHS Foundation Trust	Chichester
United Kingdom	University Hospital Coventry	Coventry
United Kingdom	Doncaster Royal Infirmary	Doncaster
United Kingdom	Dorset Country Hospital	Dorchester
United Kingdom	James Paget University Hospital	Great Yarmouth
United Kingdom	St Marks Hospital	Harrow
United Kingdom	Raigmore Hospital	Inverness
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester
United Kingdom	Macclesfield District General Hospital	Macclesfield
United Kingdom	Queen Elizabeth the Queen Mother Hospital	Margate
United Kingdom	Norfolk & Norwich University Hospital	Norwich
United Kingdom	Queens Medical Centre	Nottingham
United Kingdom	Salisbury District Hospital	Salisbury
United Kingdom	University Hospital of North Tees	Stockton-on-Tees
United Kingdom	Royal Stoke University Hospital	Stoke-on-Trent
United Kingdom	Kings Mill Hospital	Sutton in Ashfield
United Kingdom	Manor Hospital	Walsall
United Kingdom	Royal Albert Edward Infirmary	Wigan
United Kingdom	New Cross Hosptial	Wolverhampton
United Kingdom	Worcestershire Royal Hospital	Worcester
United Kingdom	Wythenshawe Hosptial	Wythenshawe
United Kingdom	Yeovil District Hospital	Yeovil
United Kingdom	York Hospital	York

Sponsors (2)

Lead Sponsor	Collaborator
University of Birmingham	LifeCell

Countries where clinical trial is conducted

Denmark,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinically detectable hernias at two years post-randomisation.		Two years post-randomisation.
Secondary	Radiological hernia rate at one 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.	One year post-randomisation.
Secondary	Incidence of developing a symptomatic hernia evaluated at 12 and 24 months postrandomisation.	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.	One and two years post-randomisation.
Secondary	Surgical re-intervention rates at 2 years post-randomisation.		Two years post-randomisation.
Secondary	Surgical complications, including wound infections and seroma formation, at 30 days postoperatively and at 1 year post-randomisation.		30 days postoperatively, 1 year post randomisation
Secondary	Quality of life assessed using EuroQol EQ-5D at baseline, 30 days post-operatively, 12 and 24 months post-randomisation.		Baseline, 30 days post-operatively, one and two years post-randomisation
Secondary	Pain assessed using a 100 point visual analogue scale at baseline, 30 days postoperatively, 12 and 24 months post-randomisation.		Baseline, 30 days post-operatively, one and two years post-randomisation
Secondary	Costs per hernia clinically detected at 2 years post-randomisation.		Two years post-randomisation.
Secondary	Two-year and long-term costs per additional quality adjusted life (QALY) year gained.		Two-year post-randomisation

External Links

•   Trial website