Parastomal HerniaNCT00691860
Use of a Mesh to Prevent Parastomal Hernia
A study testing Mesh (Ultrapro ®) and Conventional sigmoid end colostomy in people with Parastomal Hernia, run by Corporacion Parc Tauli.
Trial summary
Randomized, controlled, prospective study of 54 patients receiving surgery for cancer of the lower third of the rectum with a permanent end colostomy. The aim of the study was to reduce parastomal hernia (PH) occurrence by implanting a lightweight mesh in the sublay position. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- Mesh (Ultrapro ®) and Conventional sigmoid end colostomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for permanent end colostomy to treat cancer of the lower third of the rectum,
- Aged over 18,
- Charlson comorbidity index below 7
- Elective surgery
- Radical surgery
Who cannot join
- Loop colostomies,
- Emergency surgery,
- Body mass index above 35 kg/sq.m.,
- Palliative surgery,
- Hepatic cirrhosis,
- Severe COPD (requiring home oxygen treatment),
- Corticoid treatment
About this study
Official title: Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia
Randomized, controlled, prospective study of 54 patients receiving surgery for cancer of the lower third of the rectum with a permanent end colostomy. The aim of the study was to reduce parastomal hernia (PH) occurrence by implanting a lightweight mesh in the sublay position. Patients were followed up a) clinically and b) radiologically by means of abdominal CT. In the clinical follow-up, hernias were observed in four out of 27 patients (14.8%) in the study group and in eleven out of 27 (40.7%) in the control group (p=0.03). The implantation of the mesh reduces the appearance of PH, is well tolerated, and does not increase morbidity
- Conditions
- Parastomal Hernia
- Being tested
- Mesh (Ultrapro ®), Conventional sigmoid end colostomy
- Keywords
- Parastomal hernias, Tolerance of lightweight meshes, Paracolostomy hernias, Peristomal hernias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh (Ultrapro ®)Device
Also called Ultrapro ®
In the mesh group, the mesh was placed in the sublay position, above the peritoneum and the posterior rectus sheath of the rectus abdominis muscles, with a minimum of 5 cm of mesh around the colostomy
Conventional sigmoid end colostomyProcedure or surgery
Patients receiving conventional sigmoid end colostomy, without mesh
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients receiving conventional sigmoid end colostomy plus a lightweight mesh Ultrapro® Receives: Device: Mesh (Ultrapro ®); Procedure: Conventional sigmoid end colostomy |
| 2 | Other | Patients receiving conventional sigmoid end colostomy, without mesh Receives: Procedure: Conventional sigmoid end colostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the reduction in the incidence of Parastomal Hernia after the mesh placement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startApr 2006
- Primary completionJan 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parastomal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Investigators
- Salvador Navarro-Soto, MD, Study chair, Corporacio Sanitaria Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691860
- Sponsor's protocol ID
- CSPT-SerraA-01
- Status last verified
- Jun 2008
- First submitted
- 4 Jun 2008
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia
- ClinicalTrials.gov ID
- NCT00691860
- Acronym / sponsor ID
- CSPT-SerraA-01
- Conditions
- Parastomal Hernia
- Keywords
- Parastomal hernias, Tolerance of lightweight meshes, Paracolostomy hernias, Peristomal hernias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, controlled, prospective study of 54 patients receiving surgery for cancer of the lower third of the rectum with a permanent end colostomy. The aim of the study was to reduce parastomal hernia (PH) occurrence by implanting a lightweight mesh in the sublay position. Patients were followed up a) clinically and b) radiologically by means of abdominal CT. In the clinical follow-up, hernias were observed in four out of 27 patients (14.8%) in the study group and in eleven out of 27 (40.7%) in the control group (p=0.03). The implantation of the mesh reduces the appearance of PH, is well tolerated, and does not increase morbidity
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Mesh (Ultrapro ®), Procedure: Conventional sigmoid end colostomyPatients receiving conventional sigmoid end colostomy plus a lightweight mesh Ultrapro® |
| 2 | Other | Procedure: Conventional sigmoid end colostomyPatients receiving conventional sigmoid end colostomy, without mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients scheduled for permanent end colostomy to treat cancer of the lower third of the rectum,
- Aged over 18,
- Charlson comorbidity index below 7
- Elective surgery
- Radical surgery
Key exclusion criteria (7 listed)
- Loop colostomies,
- Emergency surgery,
- Body mass index above 35 kg/sq.m.,
- Palliative surgery,
- Hepatic cirrhosis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesh (Ultrapro ®)Also: Ultrapro ®In the mesh group, the mesh was placed in the sublay position, above the peritoneum and the posterior rectus sheath of the rectus abdominis muscles, with a minimum of 5 cm of mesh around the colostomy | Device | 1 |
| Conventional sigmoid end colostomyPatients receiving conventional sigmoid end colostomy, without mesh | Procedure or surgery | 1, 2 |
Primary outcome
the reduction in the incidence of Parastomal Hernia after the mesh placement
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvador Navarro-Soto, MD study chair
Corporacio Sanitaria Parc Tauli
Questions about this trial
What is this clinical trial studying?
A study testing Mesh (Ultrapro ®) and Conventional sigmoid end colostomy in people with Parastomal Hernia, run by Corporacion Parc Tauli.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the reduction in the incidence of Parastomal Hernia after the mesh placement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2015.