Hernia, VentralNCT00240188
A Study to Compare Ventral Incisional Hernia by Laparoscopic vs Open Repair With Mesh
A study testing Open mesh repair of ventral incisional hernia and Laparoscopic mesh repair of ventral incisional hernia in people with Hernia, Ventral, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this research is to compare open ventral incisional hernia repair to the laparoscopic repair with respect to complications, recurrence, pain, return to normal activities of daily living, and return to work. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Ventral
- What is being tested?
- Open mesh repair of ventral incisional hernia and Laparoscopic mesh repair of ventral incisional hernia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Dec 2006
- 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 will be eligible for enrollment into the study if they meet the following criteria: -Are 18 years of age or older -Have a diagnosis of ventral primary incisional hernia 9-225 cm2 in size. -Give informed consent for randomization - Have a negative pregnancy test. (Women)
Who cannot join
- Patients will be excluded for the following reasons: -Hernia cannot be detected on physical examination - Primary ventral or umbilical hernia - Small hernia defined as less than 9 cm2 - Giant hernia defined as greater than 225 cm2 in size - ASA class 4 or 5, or contraindications to general anesthesia - Severe co morbid conditions likely to limit survival to less than 3 years - History of malignancy within the past 5 years except for non-melanoma skin cancer - Cirrhosis with or without ascites - Presence of bowel obstruction( partial or intermittent), strangulation, peritonitis, or perforation. - Presence of local or systemic infection - Participation in another clinical trial - Emergency operation - Prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System, Boston
Boston, Massachusetts, 02130
About this study
Official title: Ventral Incisional Hernia Repair: Comparison Of Laparoscopic and Open Repair With Mesh
The purpose of this research is to compare open ventral incisional hernia repair to the laparoscopic repair with respect to complications, recurrence, pain, return to normal activities of daily living, and return to work.
Read the detailed description
The appearance of ventral incisional hernia (VIH) following an open abdominal operation is an important postoperative problem. While advances in anesthesia techniques, better methods to prevent surgical infections, and improved treatment of infection, and the use of new suture materials have reduced the incidence of incisional hernias, incisional hernias still occurs in 0.5-11% of all open abdominal surgical procedures performed.
Overview of study design: We are conducting a 4 center randomized clinical trial to compare the outcomes of two methods of surgical management of ventral incisional hernia. Patients presenting to a physician with a ventral incisional hernia will be considered for the trial. The study is designed to compare the rate of complications, pain, time to return to normal activities, Health related quality of life (HRQoL) and patient satisfaction between laparoscopic and open mesh repair for ventral incisional hernia. The rate of recurrence of the hernia at 1-2 years will be evaluated as a secondary outcome. Four VA medical centers with the capability of enrolling 40-50 patients a year have been selected based on volume, experience with open and laparoscopic ventral herniorrhaphy and experience in the conduct of clinical trials. Patients are recruited by physicians at each site and referred to the site coordinator who screens them for eligibility. The trial is randomized but not blinded. The randomization scheme takes into consideration that random allocation of patients to each study group is made within each center. In addition to the participating center, the other baseline variables that serve as stratification factors are first time or recurrent ventral incisional hernia and patient with a body mass index greater or less than 35arm.
Timeline: The trial consists of 3 phases: Implementation, Patient intake and follow-up, closeout and final analysis. 1-Implementation (2 months): The implementation which will include funding, recruitment of the nurse coordinators and review of the study protocol and techniques of operation was 2 months in duration. 2-Patient intake and follow up (32 months): All study patients are recruited during that period of time. Follow-up will occur simultaneously and will end at close out. The range of follow-up is expected to range from 8 weeks to 34 months. 4-Final analysis and closeout: The participating centers will be given 2 months of funding to close out the data collection. During this period, all final follow-up visits and data collection will be completed. Final analysis will run concurrently with closeout.
- Conditions
- Hernia, Ventral
- Being tested
- Open mesh repair of ventral incisional hernia, Laparoscopic mesh repair of ventral incisional hernia
- Keywords
- Hernia, Incisional, Laparoscopic, Mesh, Repair, Ventral
- Medical subject headings
- Hernia, Ventral, Hernia, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open mesh repair of ventral incisional herniaProcedure or surgery
For the open procedure, the technique, as described by Chevrel and others was adopted.
Laparoscopic mesh repair of ventral incisional herniaProcedure or surgery
For the laparoscopic repair, the method of Gagner was adopted
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Procedure: Open mesh repair of ventral incisional hernia; Procedure: Laparoscopic mesh repair of ventral incisional hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall complication rates at eight weeks and the odds of complications, adjusted for study site, body mass index, and hernia type
Measured: Eight (8) weeks post-operatively
Secondary outcomes (1)
Compare pain, return to normal activities of daily living, and return to work. Health related quality of life, and recurrence.
Measured: One (1) and two (2) years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startFeb 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hernia, VentralStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Kamal Itani, MD, Principal investigator, VA Boston Healthcare System, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240188
- Sponsor's protocol ID
- CLIN-011-03S
- Status last verified
- Sep 2010
- First submitted
- 30 Aug 2005
- Last updated
- 16 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kaafarani HM, Hur K, Campasano M, Reda DJ, Itani KM. Classification and valuation of postoperative complications in a randomized trial of open versus laparoscopic ventral herniorrhaphy. Hernia. 2010 Jun;14(3):231-5. doi: 10.1007/s10029-009-0593-z. Epub 2010 Mar 6.
PubMed 20213456Kaafarani HM, Kaufman D, Reda D, Itani KM. Predictors of surgical site infection in laparoscopic and open ventral incisional herniorrhaphy. J Surg Res. 2010 Oct;163(2):229-34. doi: 10.1016/j.jss.2010.03.019. Epub 2010 Apr 1.
PubMed 20605590Itani KM, Neumayer L, Reda D, Kim L, Anthony T. Repair of ventral incisional hernia: the design of a randomized trial to compare open and laparoscopic surgical techniques. Am J Surg. 2004 Dec;188(6A Suppl):22S-29S. doi: 10.1016/j.amjsurg.2004.09.006.
PubMed 15610889Kaafarani HM, Hur K, Hirter A, Kim LT, Thomas A, Berger DH, Reda D, Itani KM. Seroma in ventral incisional herniorrhaphy: incidence, predictors and outcome. Am J Surg. 2009 Nov;198(5):639-44. doi: 10.1016/j.amjsurg.2009.07.019.
PubMed 19887192Itani KM, Hur K, Kim LT, Anthony T, Berger DH, Reda D, Neumayer L; Veterans Affairs Ventral Incisional Hernia Investigators. Comparison of laparoscopic and open repair with mesh for the treatment of ventral incisional hernia: a randomized trial. Arch Surg. 2010 Apr;145(4):322-8; discussion 328. doi: 10.1001/archsurg.2010.18.
PubMed 20404280
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventral Incisional Hernia Repair: Comparison Of Laparoscopic and Open Repair With Mesh
- ClinicalTrials.gov ID
- NCT00240188
- Acronym / sponsor ID
- CLIN-011-03S
- Conditions
- Hernia, Ventral
- Keywords
- Hernia, Incisional, Laparoscopic, Mesh, Repair, Ventral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Feb 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 17 Oct 2005 (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 purpose of this research is to compare open ventral incisional hernia repair to the laparoscopic repair with respect to complications, recurrence, pain, return to normal activities of daily living, and return to work.
Detailed description
The appearance of ventral incisional hernia (VIH) following an open abdominal operation is an important postoperative problem. While advances in anesthesia techniques, better methods to prevent surgical infections, and improved treatment of infection, and the use of new suture materials have reduced the incidence of incisional hernias, incisional hernias still occurs in 0.5-11% of all open abdominal surgical procedures performed.
Overview of study design: We are conducting a 4 center randomized clinical trial to compare the outcomes of two methods of surgical management of ventral incisional hernia. Patients presenting to a physician with a ventral incisional hernia will be considered for the trial. The study is designed to compare the rate of complications, pain, time to return to normal activities, Health related quality of life (HRQoL) and patient satisfaction between laparoscopic and open mesh repair for ventral incisional hernia. The rate of recurrence of the hernia at 1-2 years will be evaluated as a secondary outcome. Four VA medical centers with the capability of enrolling 40-50 patients a year have been selected based on volume, experience with open and laparoscopic ventral herniorrhaphy and experience in the conduct of clinical trials. Patients are recruited by physicians at each site and referred to the site coordinator who screens them for eligibility. The trial is randomized but not blinded. The randomization scheme takes into consideration that random allocation of patients to each study group is made within each center. In addition to the participating center, the other baseline variables that serve as stratification factors are first time or recurrent ventral incisional hernia and patient with a body mass index greater or less than 35arm.
Timeline: The trial consists of 3 phases: Implementation, Patient intake and follow-up, closeout and final analysis. 1-Implementation (2 months): The implementation which will include funding, recruitment of the nurse coordinators and review of the study protocol and techniques of operation was 2 months in duration. 2-Patient intake and follow up (32 months): All study patients are recruited during that period of time. Follow-up will occur simultaneously and will end at close out. The range of follow-up is expected to range from 8 weeks to 34 months. 4-Final analysis and closeout: The participating centers will be given 2 months of funding to close out the data collection. During this period, all final follow-up visits and data collection will be completed. Final analysis will run concurrently with closeout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Open mesh repair of ventral incisional hernia, Procedure: Laparoscopic mesh repair of ventral incisional hernia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will be eligible for enrollment into the study if they meet the following criteria: -Are 18 years of age or older -Have a diagnosis of ventral primary incisional hernia 9-225 cm2 in size. -Give informed consent for randomization - Have a negative pregnancy test. (Women)
Key exclusion criteria (1 listed)
- Patients will be excluded for the following reasons: -Hernia cannot be detected on physical examination - Primary ventral or umbilical hernia - Small hernia defined as less than 9 cm2 - Giant hernia defined as greater than 225 cm2 in size - ASA class 4 or 5, or contraindications to general anesthesia - Severe co morbid conditions likely to limit survival to less than 3 years - History of malignancy within the past 5 years except for non-melanoma skin cancer - Cirrhosis with or without ascites - Presence of bowel obstruction( partial or intermittent), strangulation, peritonitis, or perforation. - Presence of local or systemic infection - Participation in another clinical trial - Emergency operation - Prisoner
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 |
|---|---|---|
| Open mesh repair of ventral incisional herniaFor the open procedure, the technique, as described by Chevrel and others was adopted. | Procedure or surgery | 1 |
| Laparoscopic mesh repair of ventral incisional herniaFor the laparoscopic repair, the method of Gagner was adopted | Procedure or surgery | 1 |
Primary outcome
Overall complication rates at eight weeks and the odds of complications, adjusted for study site, body mass index, and hernia type
Time frame: Eight (8) weeks post-operatively
1 secondary outcome
Compare pain, return to normal activities of daily living, and return to work. Health related quality of life, and recurrence.
Time frame: One (1) and two (2) years post-operatively
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 16 Sep 2010.
- Results publication: PubMed 20213456Kaafarani HM, Hur K, Campasano M, Reda DJ, Itani KM. Classification and valuation of postoperative complications in a randomized trial of open versus laparoscopic ventral herniorrhaphy. Hernia. 2010 Jun;14(3):231-5. doi: 10.1007/s10029-009-0593-z. Epub 2010 Mar 6.
- Results publication: PubMed 20605590Kaafarani HM, Kaufman D, Reda D, Itani KM. Predictors of surgical site infection in laparoscopic and open ventral incisional herniorrhaphy. J Surg Res. 2010 Oct;163(2):229-34. doi: 10.1016/j.jss.2010.03.019. Epub 2010 Apr 1.
- Results publication: PubMed 15610889Itani KM, Neumayer L, Reda D, Kim L, Anthony T. Repair of ventral incisional hernia: the design of a randomized trial to compare open and laparoscopic surgical techniques. Am J Surg. 2004 Dec;188(6A Suppl):22S-29S. doi: 10.1016/j.amjsurg.2004.09.006.
- Results publication: PubMed 19887192Kaafarani HM, Hur K, Hirter A, Kim LT, Thomas A, Berger DH, Reda D, Itani KM. Seroma in ventral incisional herniorrhaphy: incidence, predictors and outcome. Am J Surg. 2009 Nov;198(5):639-44. doi: 10.1016/j.amjsurg.2009.07.019.
- Results publication: PubMed 20404280Itani KM, Hur K, Kim LT, Anthony T, Berger DH, Reda D, Neumayer L; Veterans Affairs Ventral Incisional Hernia Investigators. Comparison of laparoscopic and open repair with mesh for the treatment of ventral incisional hernia: a randomized trial. Arch Surg. 2010 Apr;145(4):322-8; discussion 328. doi: 10.1001/archsurg.2010.18.
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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.
Kamal Itani, MD principal investigator
VA Boston Healthcare System, Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open mesh repair of ventral incisional hernia and Laparoscopic mesh repair of ventral incisional hernia in people with Hernia, Ventral, run by US Department of Veterans Affairs at 1 site in United States.
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 1 inclusion and 1 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 16 Sep 2010. 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 United States. 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.
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?
Overall complication rates at eight weeks and the odds of complications, adjusted for study site, body mass index, and hernia type (time frame: Eight (8) weeks post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00240188, which also lists 5 linked publications.
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 16 Sep 2010.