Port-site HerniaPhase 3NCT01802229
Prevention of Umbilical Port-site Hernia After Laparoscopic Cholecystectomy Using a Prosthetic Mesh Versus Simple Suture
A Phase 3 study testing Prophylactic mesh placement and Fascial suture in people with Port-site Hernia, run by Hospital General Universitario Elche at 1 site in Spain.
Trial summary
The incidence of port-site hernia in patients with risk factors (obesity, elderly, diabetes and lung disorders) can be reduced by the use of a prophylactic mesh in the closure of umbilical port site. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Port-site Hernia
- What is being tested?
- Prophylactic mesh placement and Fascial suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Dec 2012
- Phase
- Phase 3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 65 years
- BMI > 30 Kg/m2
- Diabetes mellitus
- Lung disease
- Elective laparoscopic cholecystectomy
Who cannot join
- Umbilical hernia
- Previous laparotomy
- Conversion to open procedure
- Loss during the follow up
Trial locations and contacts
1 site in 1 country.
About this study
The incidence of port-site hernia in patients with risk factors (obesity, elderly, diabetes and lung disorders) can be reduced by the use of a prophylactic mesh in the closure of umbilical port site.
- Conditions
- Port-site Hernia
- Being tested
- Prophylactic mesh placement, Fascial suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic mesh placementProcedure or surgery
Placement of a Omega 3 mesh, fixed to the border of the fascia
Fascial sutureProcedure or surgery
The port-site hole is closed with simple suture of the fascia
| Study group | Role | What they receive |
|---|---|---|
| Suture | Active comparator | Umbilical port-site closure with simple suture of the fascia. Receives: Procedure: Fascial suture |
| Prophylactic mesh | Experimental | Umbilical port-site closure with mesh placement Receives: Procedure: Prophylactic mesh placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of port-site hernia
Comparison of incidence of port-site hernia between patiensts with and without prophylactic mesh placement
Measured: 12 months
Secondary outcomes (1)
Postoperative pain
Evaluation of different pain perception in patients with and without prophylactic mesh placement, determined in the postoperative course and at 1, 6 and 12 months after surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Port-site 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802229
- Sponsor's protocol ID
- 2013-002
- Status last verified
- Feb 2013
- First submitted
- 27 Feb 2013
- Last updated
- 1 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Umbilical Port-site Hernia After Laparoscopic Cholecystectomy Using a Prosthetic Mesh Versus Simple Suture
- ClinicalTrials.gov ID
- NCT01802229
- Acronym / sponsor ID
- 2013-002
- Conditions
- Port-site Hernia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Mar 2013 (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.
The incidence of port-site hernia in patients with risk factors (obesity, elderly, diabetes and lung disorders) can be reduced by the use of a prophylactic mesh in the closure of umbilical port site.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suture | Active comparator | Procedure: Fascial sutureUmbilical port-site closure with simple suture of the fascia. |
| Prophylactic mesh | Experimental | Procedure: Prophylactic mesh placementUmbilical port-site closure with mesh placement |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 65 years
- BMI > 30 Kg/m2
- Diabetes mellitus
- Lung disease
- Elective laparoscopic cholecystectomy
Key exclusion criteria (4 listed)
- Umbilical hernia
- Previous laparotomy
- Conversion to open procedure
- Loss during the follow up
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 |
|---|---|---|
| Prophylactic mesh placementPlacement of a Omega 3 mesh, fixed to the border of the fascia | Procedure or surgery | Prophylactic mesh |
| Fascial sutureThe port-site hole is closed with simple suture of the fascia | Procedure or surgery | Suture |
Primary outcome
Incidence of port-site hernia
Time frame: 12 months
Comparison of incidence of port-site hernia between patiensts with and without prophylactic mesh placement
1 secondary outcome
Postoperative pain
Time frame: 12 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 1 Mar 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prophylactic mesh placement and Fascial suture in people with Port-site Hernia, run by Hospital General Universitario Elche at 1 site in Spain.
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 4 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 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of port-site hernia (time frame: 12 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 1 Mar 2013.