Condition category
Digestive System
Date applied
22/10/2013
Date assigned
11/12/2013
Last edited
11/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mats Blackberg

ORCID ID

Contact details

Sodra Vallgatan 5
Helsingborg
25437
Sweden
mats.blackberg@skane.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Prophylactic mest at Bricker urostmy - a prospective randomized multicenter trial regarding stoma hernia with or without mesh

Acronym

Study hypothesis

Parastomal mesh lower the frequency of parastomal hernias.

Ethics approval

Ethics Committee Etikprövningsnämnden aprroval on 22/05/2012, reference 2012/236

Study design

Prospective randomized multicenter trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Number of parastomal hernia at 6, 12 and 24 months postoperatively

Secondary outcome measures

1. Infection frequency at 30 days postoperatively
2. Net related complications during 24 months postoperatively
3. Cost of stomal bandaging 24 months postoperatively

Overall trial start date

01/06/2012

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient planned for cystectomy with Bricker conductor
2. Patient age above age of 18

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. History of former abdominal stoma
2. Present abdominal stoma
3. Former or present abdominal wall hernia

Recruitment start date

01/06/2012

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Sweden

Trial participating centre

Sodra Vallgatan 5
Helsingborg
25437
Sweden

Sponsor information

Organisation

Thelma Zoega Foundation (Sweden)

Sponsor details

Box 117
Lund
22100
Sweden
matilda.wadenbaeck@eken.lu.se

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Stig and Ragna Gorthon Foundation (Sweden) No 86485

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Thelma Zoega Foundation (Sweden) No 86476

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes