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.
ID
Source
Brief title
Condition
- Abdominal hernias and other abdominal wall conditions
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Occurrence of clinically detectable hernias at two years post closure
Secondary outcome
1. Radiological hernia rate at one year post closure. 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.
2. Surgical re-intervention rate.
3. Surgical complications at 30 days and 1 year.
4. Quality of life and post-operative pain.
5. Cost-benefit analysis.
Background summary
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.
Study objective
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.
Study design
The intervention in the experimental arm consists of suturing an acellular
biological mesh derived from porcine dermis in the abdominal wall, followed by
normal abdominal closure similar to the control arm. 560 patients will be
randomised over 2 years from at least 30 centres. ROCSS will be a single 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.
Intervention
The intervention in the experimental arm consists of suturing an acellular
biological mesh derived from porcine dermis in the abdominal wall defect,
followed by closure of the skin, fascia and subcutis similar to the control
arm.
Study burden and risks
Potential additional risk related to the use of biological mesh is increased
postoperative pain and seroma formation, which is mostly transient and does not
require invasive treatment. The extra burden of participation consists of
additional radiation exposure, outpatient clinic visits and questionnaires.
Birmingham B152TT
Amsterdam 1105AZ
NL
Birmingham B152TT
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Require an elective closure of an ileostomy or a colostomy. Those patients undergoing a
Stoma closure involving both a colostomy and an ileostomy element are eligible and should be
Stratified as colostomy patients.
Be able and willing to provide written informed consent for the study
Be 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.
Unable or unwilling to provide written informed consent.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47356.018.13 |