Incisional HerniaPhase 1NCT00891254
Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh
A Phase 1 study testing Implant of a prosthetic mesh in people with Incisional Hernia, run by Cirujanos la Serena at 1 site in Chile.
Trial summary
The intraperitoneal repair has been proven safe for the repair of incisional hernia and is accepted, together with the subfascial or retromuscular repair as the "gold-standard" for the repair of incisional hernia. However no studies have convincingly proven that this approach is better than the on-lay repair. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Implant of a prosthetic mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChile
- Study dates
- Jan 2009to Jul 2012
- Phase
- Phase 1
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with incisional hernia 5 cm of diameter or with an area of 25 square cm (cm2)
- First repair
- Older than 35 years of age and younger than 75 years of age
- Both genders
- Any BMI
- Only upper abdominal midline incisional hernias (supraumbilical)
- Patients submitted only to elective repair
Who cannot join
- Recurrent incisional hernia
- Emergency surgery
- Hernias with a diameter higher than 5 cm or more than 25 cm2 of area
- Lower midline abdominal incisional hernias
- Other hernias rather than midline incisional hernias
- Non-incisional hernias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study of Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh Versus On-lay Mesh Repair
The intraperitoneal repair has been proven safe for the repair of incisional hernia and is accepted, together with the subfascial or retromuscular repair as the "gold-standard" for the repair of incisional hernia. However no studies have convincingly proven that this approach is better than the on-lay repair.
The authors believe that the intraperitoneal repair performs better than the on-lay repair for incisional hernia.
- Conditions
- Incisional Hernia
- Being tested
- Implant of a prosthetic mesh
- Keywords
- Incisional hernia, Intraperitoneal mesh repair, On-lay repair, Prosthetic mesh, First repair (no recurrent hernia will be included), Recurrence, Complications
- Medical subject headings
- Incisional Hernia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant of a prosthetic meshDevice
A prosthetic mesh will be implanted either intraperitoneally or in the on-lay (supra-fascial) position depending on the arm of the study
| Study group | Role | What they receive |
|---|---|---|
| 1. Intraperitoneal repair | Active comparator | Patients with incisional hernia, 5 cm in diameter or with an area of 25 cm2, submitted to elective surgery Receives: Device: Implant of a prosthetic mesh |
| 2. On-Lay repair | Active comparator | Patients with incisional hernia, with a diameter of 5 cm or an area of 25 cm2, submitted to elective surgery Receives: Device: Implant of a prosthetic mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term recurrence
Measured: 5 years
Secondary outcomes (1)
Short-term complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cirujanos la Serena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARCELO A. BELTRAN, M.D., Cirujanos la Serena
- Investigators
- MARCELO A BELTRAN, M.D., Principal investigator, Hospital de La Serena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891254
- Sponsor's protocol ID
- HLS-2904009-03
- Status last verified
- Oct 2012
- First submitted
- 30 Apr 2009
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh Versus On-lay Mesh Repair
- ClinicalTrials.gov ID
- NCT00891254
- Acronym / sponsor ID
- HLS-2904009-03
- Conditions
- Incisional Hernia
- Keywords
- Incisional hernia, Intraperitoneal mesh repair, On-lay repair, Prosthetic mesh, First repair (no recurrent hernia will be included), Recurrence, Complications
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cirujanos la SerenaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 May 2009 (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 intraperitoneal repair has been proven safe for the repair of incisional hernia and is accepted, together with the subfascial or retromuscular repair as the "gold-standard" for the repair of incisional hernia. However no studies have convincingly proven that this approach is better than the on-lay repair.
The authors believe that the intraperitoneal repair performs better than the on-lay repair for incisional hernia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Intraperitoneal repair | Active comparator | Device: Implant of a prosthetic meshPatients with incisional hernia, 5 cm in diameter or with an area of 25 cm2, submitted to elective surgery |
| 2. On-Lay repair | Active comparator | Device: Implant of a prosthetic meshPatients with incisional hernia, with a diameter of 5 cm or an area of 25 cm2, submitted to elective surgery |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with incisional hernia 5 cm of diameter or with an area of 25 square cm (cm2)
- First repair
- Older than 35 years of age and younger than 75 years of age
- Both genders
- Any BMI
Key exclusion criteria (6 listed)
- Recurrent incisional hernia
- Emergency surgery
- Hernias with a diameter higher than 5 cm or more than 25 cm2 of area
- Lower midline abdominal incisional hernias
- Other hernias rather than midline incisional hernias
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 |
|---|---|---|
| Implant of a prosthetic meshA prosthetic mesh will be implanted either intraperitoneally or in the on-lay (supra-fascial) position depending on the arm of the study | Device | 1. Intraperitoneal repair, 2. On-Lay repair |
Primary outcome
Long-term recurrence
Time frame: 5 years
1 secondary outcome
Short-term complications
Time frame: 1 year
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 31 Oct 2012.
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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.
MARCELO A BELTRAN, M.D. principal investigator
Hospital de La Serena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Implant of a prosthetic mesh in people with Incisional Hernia, run by Cirujanos la Serena at 1 site in Chile.
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 7 inclusion and 6 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 31 Oct 2012. 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 Chile. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Long-term recurrence (time frame: 5 years). 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 31 Oct 2012.