Reinforcement of closure of stoma site using a biological mesh

ISRCTN	ISRCTN46330337
DOI	https://doi.org/10.1186/ISRCTN46330337
ClinicalTrials.gov (NCT)	NCT02238964
Protocol serial number	13461
Sponsor	University of Birmingham (UK)
Funders	LifeCell, Research for Patient Benefit - NIHR

Submission date: 28/11/2012
Registration date: 30/11/2012
Last edited: 24/03/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
An incisional hernia forms when a surgical wound fails to heal and a defect remains in the muscle wall. Closure of a stoma wound (stomas are formed when the bowel is brought to the tummy skin) is a frequent cause of incisional hernia, occurring in over 1,000 UK patients every year. Surgical repair of these hernias is hazardous and up to 1 in 2 repairs will fail. These patients can be elderly with multiple medical problems, so further attempts at repair may be too risky, meaning they must tolerate the symptoms of pain, swelling and discomfort and live with the risk of life-threatening complications. A treatment that reduces the occurrence of hernias after stoma closure would improve patients’ quality of life, reduce surgical complications and remove the need for further operations. This study seeks to address this problem by the use of a mesh to support the wound while it heals. Meshes are widely used in hernia repair to support the muscles while they heal. However, the mesh increases the problems of infection when the wound is contaminated by bacteria (as is the case in stoma closure). We are using a type of ‘biological’ mesh made from animal tissue which is incorporated into the body tissues. Animal and human studies indicate that long-term infection problems are, as a consequence, reduced. Our preliminary study of 90 patients has shown this procedure can be performed safely. This study will test this new mesh against the standard procedure.

Who can participate?
Patients aged 18 or over undergoing an operation on their bowel to close their stoma.

What does the study involve?
Most of the treatment you receive will be the same as you would have received even if you were not in a study. There are no extra blood tests or operations required beyond your normal care and there are no additional clinic visits. You will also be asked to complete a short questionnaire about your quality of life before your operation, as well as a further questionnaire at 1, 12 and 24 months after your operation. You will then have your operation and will be randomly allocated to either have a mesh inserted at the time of surgery or have a standard stoma closure. You will not be told which group you are in so as not to influence the results in any way. After your operation you will receive the normal postoperative care, regardless of which group you are in. Once you have had your surgery we will need to collect information about the operation and any complications (e.g. how long the operation took, if there was any excess bleeding after the operation, if you had any unexpected pain). You will be followed up in clinic and examined by a doctor to assess whether a hernia has developed. Most of this information will be collected at routine out-patient appointments. You will receive one follow-up telephone call around 9 months after the operation date to see how you are recovering and make sure you have not had any problems with wound infection or any other side effect. All information collected will be strictly confidential in the same way as your other medical records.

What are the possible benefits and risks of participating?
As part of the study, we will ask you to undergo a CT scan at 12 months after surgery. This CT scan is to assess if a hernia has developed which may not have been picked up by a routine clinical examination. This CT scan would be routine for some patients taking part in the study but will be additional for others. The scan involves radiation. The dose from a single CT scan is equivalent to about 3 years of natural background radiation. Any radiation is associated with an increased risk of developing cancer. However, the risk associated with a single CT scan is very small (about 1 in 3000) and negligible when compared with the 1 in 4 lifetime risk of cancer.

Where is the study run from?
Queen Elizabeth Hospital and 34 other hospitals in the UK, Netherlands and Denmark.

When is the study starting and how long is it expected to run for?
From October 2012 to August 2018

Who is funding the study?
LifeCell (USA).

Who is the main contact?
Prof Dion Morton
dion.morton@uhb.nhs.uk

Contact information

Prof Dion Morton
Scientific

Academic Department of Surgery
School of Medicine
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom

Email	dion.morton@uhb.nhs.uk

Dr ROCSS Trial Office -
Scientific

Birmingham Clinical Trials Unit (BCTU)
School of Health & Population Sciences
Public Health Building
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)121 415 9965
Email	rocss@trials.bham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised controlled trial of Reinforcement Of Closure of Stoma Site using a biological mesh
Study acronym	ROCSS
Study objectives	Abdominal wall hernias are common and are a significant cause of morbidity. Incisional hernias form following closure of the abdominal wall musculature. Incisional hernias at the site of stoma closure are not an infrequent problem, occurring in up to 30% of cases. Not only are they associated with adverse effects on patient's quality of life but in up to 10 % of cases, patients require complex reoperation associated with a high complication rate. It is for this reason that many patients choose to live with the hernia rather than undergo further surgery. Techniques that prevent the hernia from developing would improve the patient's quality of life and reduce the costs associated with redo surgery. Repair of incisional hernia commonly employs prosthetic meshes that reinforce and aid the tissue healing process. It is inappropriate to use synthetic mesh at site of previous stomas as there has been leakage of bowel contents that would infect the mesh and further compound the healing process. Many surgeons therefore choose to close the defect with sutures rather than using mesh. This may be a contributory factor in the subsequent development of hernias. Biological mesh implants may be more suitable in these circumstances. There is no evidence regarding the benefits of using biological mesh to prevent hernias at site of stoma closure. The balance of risks and benefits has not been reliably assessed in a randomised control trial. 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. More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13461 Protocol can be found at: http://www.birmingham.ac.uk/Documents/college-mds/trials/bctu/rocss/ROCSS-Protocol-v4-08Oct2014.pdf
Ethics approval(s)	NRES Committee West Midlands - Coventry & Warwickshire; conditional approval was given on 04/07/2012 with confirmation of compliance with the conditions received on 07/08/2012, ref: 12/WM/0187
Health condition(s) or problem(s) studied	Topic: Oral and Gastrointestinal, Generic Health Relevance and Cross Cutting Themes; Subtopic: Oral and Gastrointestinal (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Gastrointestinal, Surgery
Intervention	Reinforcement of the stoma closure site using the Strattice® collagen mesh.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Recruitment at 12 months Added 03/06/2015: Full phase III: Rate of clinically detectable hernias at two years post-randomisation.
Key secondary outcome measure(s)	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
Completion date	01/08/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	790
Total final enrolment	790
Key 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
Key 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
Date of first enrolment	20/11/2012
Date of final enrolment	30/10/2015

Locations

Countries of recruitment

United Kingdom
England
Denmark
Netherlands

Study participating centres

Queen Elizabeth Hospital

Birmingham
B15 2TH
United Kingdom

34 other hospitals

-
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	feasibility study results	01/09/2016	10/04/2019	Yes	No
Results article		08/02/2020	24/03/2021	Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

24/03/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
10/04/2019: Publication reference added.
10/01/2017: the following changes were made to the trial record:
1. The overall trial end date was changed from 31/10/2017 to 01/08/2018.
2. Research for Patient Benefit - NIHR was added to the list of funders.
18/09/2015: the overall trial end date was changed from 30/09/2017 to 31/10/2017.
03/06/2015: the following changes were made to the trial record:
1. The target number of participants was changed from 90 to 790.
2. The overall trial end date was changed from 29/10/2013 to 30/09/2017.
3. Denmark and The Netherlands were added to the countries of recruitment.
The registration was initiated on 09/11/2012 and finalised on 30/11/2012. Following the prospective submission on 09/11/2012, there were no subsequent changes to the protocol.