Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00240188
Status:
COMPLETED
Last Update Posted:
2010-09-16
First Post:
2005-08-30
Brief Title:
A Study to Compare Ventral Incisional Hernia by Laparoscopic vs Open Repair With Mesh
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Ventral Incisional Hernia Repair Comparison Of Laparoscopic and Open Repair With Mesh
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 05-11 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None