Prophylactic mesh in urostomies does it help to prevent stoma hernia?
| ISRCTN | ISRCTN95093825 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95093825 |
| Protocol serial number | N/A |
| Sponsor | Thelma Zoega Foundation (Sweden) |
| Funders | Stig and Ragna Gorthon Foundation (Sweden) No 86485, Thelma Zoega Foundation (Sweden) No 86476 |
- Submission date
- 22/10/2013
- Registration date
- 11/12/2013
- Last edited
- 19/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Removal of the bladder (called cystectomy) is sometimes necessary, for example when serious forms of bladder cancer are diagnosed. After a bladder removal, the urine must be collected somehow. The most common way to do that is via a urostomy, when a section of the small intestine is drawn through the abdominal wall and a plastic bag is placed at the end on the skin in order to collect urine. A urostomy may cause a hernia and a 50% risk has been seen in some studies. Abdominal content (fat or small intestine) will bulge out and make the attachment of the plastic bag difficult. A hernia can also cause pain, discomfort or bowel obstruction (called ileus) and an operation will be needed. One way to prevent the formation of a hernia is to put a mesh (a plastic net) around the urostomy. The aim of the study is to assess whether using such a mesh will reduce the number of hernias.
Who can participate?
All patients undergoing cystectomy who are above 18 and have not had a stoma (opening of the abdomen) or hernia before.
What does the study involve?
Half of them will be operated the new way, with a mesh and the other half will be operated the old way, without. All patients above the age of 18 and not having a stoma or hernia before, can participate. We will check the patients with clinical examination and computed tomography (CT) 3, 6, 12 and 24 months after operation and look for hernias, complications of the mesh and evaluate how easy it is to bandage the urostomy. We want to include 200 patients in the study.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
The study is led from Helsingborg (Sweden) and there are three sites.
When is the study starting and how long is it expected to run for?
The study started in May 2012 and the aim is to include 200 patients by 2015. The final results are expected to be published in 2017-2018.
Who is funding the study?
Stig and Ragna Gorthon Foundation and Thelma Zoega Foundation (Sweden).
Who is the main contact?
Dr Petter Kollberg
petter.kollberg@skane.se
Contact information
Scientific
Sodra Vallgatan 5
Helsingborg
25437
Sweden
| mats.blackberg@skane.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomized multicenter trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Prophylactic mest at Bricker urostmy - a prospective randomized multicenter trial regarding stoma hernia with or without mesh |
| Study objectives | Parastomal mesh lower the frequency of parastomal hernias. |
| Ethics approval(s) | Ethics Committee Etikprövningsnämnden aprroval on 22/05/2012, reference 2012/236 |
| Health condition(s) or problem(s) studied | Abdominal wall hernia |
| Intervention | Application of a retromuscular parastomal composite net versus no net. We randomize patients to either have a stoma mesh or not. The mesh is applied around the stoma, in the abdominal wall behind the rectus muscle. Those operated without a mesh are operated using the standard procedure. All participants will be followed for 24 months and undergo at computerized tomography (CT) at 6, 12 and 24 months. |
| Intervention type | Other |
| Primary outcome measure(s) |
Number of parastomal hernia at 6, 12 and 24 months postoperatively |
| Key secondary outcome measure(s) |
1. Infection frequency at 30 days postoperatively |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Total final enrolment | 242 |
| Key inclusion criteria | 1. Patient planned for cystectomy with Bricker conductor 2. Patient age above age of 18 |
| Key exclusion criteria | 1. History of former abdominal stoma 2. Present abdominal stoma 3. Former or present abdominal wall hernia |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- Sweden
Study participating centre
25437
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2020 | 19/08/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/08/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
