Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032448
Status:
COMPLETED
Last Update Posted:
2011-04-14
First Post:
2002-03-20
Brief Title:
Does Tension-Free Herniorrhaphy or Laparoscopic Herniorrhaphy Achieve Equal or Better Recurrence Rates and Lower Costs While Achieving Equivalent Outcomes for Hernia Patients
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 456 - Tension Free Inguinal Hernia Repair Comparison of Open and Laparoscopic Surgical Techniques
Status:
COMPLETED
Status Verified Date:
2011-04
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:
Inguinal hernia is one of the most common worldwide afflictions of men The presence of an inguinal hernia is indication for its repair Approximately 700000 hernia repairs are performed in the US each year and this procedure accounts for 10 of all general surgery procedures in the Veterans Health Administration VHA 10000 inguinal herniorrhaphies performed per year There are many different techniques currently in use for repairing inguinal hernias and with the advent of laparoscopy yet another technique is being advocated Laparoscopic repair has been reported in some studies to be superior to open repair because of less pain and earlier return to work However laparoscopic repair requires a general or regional anesthetic and expensive equipment and supplies to perform There is also evidence that open tension-free mesh repair may have results similar to laparoscopic repair for these patient centered outcome measures The general acceptance of this procedure especially in the VHA has not been uniform Furthermore no randomized trial of sufficient size and power to be conclusive has been done to set forth the operative gold standard for hernia repair
Detailed Description:
Primary Hypothesis Open tension-free herniorrhaphy when compared with laparoscopic herniorrhaphy will achieve equal or better recurrence rates and lower costs while achieving equivalent outcomes for patient-centered measures
Secondary Hypotheses
Intervention Patients randomized to open repair will undergo a standardized tension-free herniorrhaphy with prosthesis method of Lichtenstein Patients randomized to laparoscopic herniorrhaphy will undergo a standardized preperitoneal repair with prosthesis using either a transperitoneal or extraperitoneal approach During the implementation period of the trial a preliminary laboratory session will be conducted with all site PIs to standardize herniorrhaphy techniques reach consensus on all aspects of perioperative patient management including postoperative patient instructions follow-up schedules definitions of recurrence and complications and to ensure that the site PI is thoroughly familiar with the protocol
Each site will be visited by one of two expert surgeons the Study Chair or a Co-PI surgeon to observe the operative procedures and ensure that participating surgeons adhere to the protocol in all respects The first visit will take place in the first 6 months of the study and then as needed thereafter based on routine examination of operative records randomly selected from each site 5 open and 5 laparoscopic herniorrhaphies and if appropriate viewing of videotapes of the laparoscopic procedures
Primary Outcomes Hernia recurrence rate
Study Abstract
Background Inguinal hernia is one of the most common worldwide afflictions of men The presence of an inguinal hernia is indication for its repair Approximately 700000 hernia repairs are performed in the US each year and this procedure accounts for 10 of all general surgery procedures in the Veterans Health Administration VHA 10000 inguinal herniorrhaphies performed per year There are many different techniques currently in use for repairing inguinal hernias and with the advent of laparoscopy yet another technique is being advocated Laparoscopic repair has been reported in some studies to be superior to open repair because of less pain and earlier return to work However laparoscopic repair requires a general or regional anesthetic and expensive equipment and supplies to perform There is also evidence that open tension-free mesh repair may have results similar to laparoscopic repair for these patient centered outcome measures The general acceptance of this procedure especially in the VHA has not been uniform Furthermore no randomized trial of sufficient size and power to be conclusive has been done to set forth the operative gold standard for hernia repair
Objectives To determine whether open tension-free herniorrhaphy when compared with laparoscopic herniorrhaphy can achieve equal or better recurrence rates and lower costs while achieving equivalent outcomes for patient-centered measures
Methods This multi-center VA cooperative study is enrolling 2200 men with inguinal hernia and randomizing them to one of two operative techniques open tension-free Lichtenstein repair or laparoscopic preperitoneal repair The primary outcome measure is recurrence at two years Secondary outcome measures are complications pain time to return to normal activities health-related quality of life patient satisfaction caregiver burden and cost The role of comorbidity in the outcome will also be determined The sample size will permit at least 80 power to detect a difference of 3 in 2-year recurrence rates between the two surgical procedures Fourteen VAMCs are randomizing the 2200 patients over a 3-year accrual period The study will also have a 2-year follow-up period All patients will be followed to the end of the study so that follow-up will range from 2-5 years average 35 years
On November 29 2001 the Hines Cooperative Studies Human Rights Committee and the Data and Safety Monitoring Board met to review the data from CSP 456 Both committees determined that there were sufficient data to complete the trial without enrolling any additional patients and recommended that enrollment be stopped There were no safety concerns Approximately 2165 patients of a targeted 2200 had been enrolled at this point All sites were notified of this within 24 hours of the action
Main Manuscript
Secondary Hypotheses
Intervention Patients randomized to open repair will undergo a standardized tension-free herniorrhaphy with prosthesis method of Lichtenstein Patients randomized to laparoscopic herniorrhaphy will undergo a standardized preperitoneal repair with prosthesis using either a transperitoneal or extraperitoneal approach During the implementation period of the trial a preliminary laboratory session will be conducted with all site PIs to standardize herniorrhaphy techniques reach consensus on all aspects of perioperative patient management including postoperative patient instructions follow-up schedules definitions of recurrence and complications and to ensure that the site PI is thoroughly familiar with the protocol
Each site will be visited by one of two expert surgeons the Study Chair or a Co-PI surgeon to observe the operative procedures and ensure that participating surgeons adhere to the protocol in all respects The first visit will take place in the first 6 months of the study and then as needed thereafter based on routine examination of operative records randomly selected from each site 5 open and 5 laparoscopic herniorrhaphies and if appropriate viewing of videotapes of the laparoscopic procedures
Primary Outcomes Hernia recurrence rate
Study Abstract
Background Inguinal hernia is one of the most common worldwide afflictions of men The presence of an inguinal hernia is indication for its repair Approximately 700000 hernia repairs are performed in the US each year and this procedure accounts for 10 of all general surgery procedures in the Veterans Health Administration VHA 10000 inguinal herniorrhaphies performed per year There are many different techniques currently in use for repairing inguinal hernias and with the advent of laparoscopy yet another technique is being advocated Laparoscopic repair has been reported in some studies to be superior to open repair because of less pain and earlier return to work However laparoscopic repair requires a general or regional anesthetic and expensive equipment and supplies to perform There is also evidence that open tension-free mesh repair may have results similar to laparoscopic repair for these patient centered outcome measures The general acceptance of this procedure especially in the VHA has not been uniform Furthermore no randomized trial of sufficient size and power to be conclusive has been done to set forth the operative gold standard for hernia repair
Objectives To determine whether open tension-free herniorrhaphy when compared with laparoscopic herniorrhaphy can achieve equal or better recurrence rates and lower costs while achieving equivalent outcomes for patient-centered measures
Methods This multi-center VA cooperative study is enrolling 2200 men with inguinal hernia and randomizing them to one of two operative techniques open tension-free Lichtenstein repair or laparoscopic preperitoneal repair The primary outcome measure is recurrence at two years Secondary outcome measures are complications pain time to return to normal activities health-related quality of life patient satisfaction caregiver burden and cost The role of comorbidity in the outcome will also be determined The sample size will permit at least 80 power to detect a difference of 3 in 2-year recurrence rates between the two surgical procedures Fourteen VAMCs are randomizing the 2200 patients over a 3-year accrual period The study will also have a 2-year follow-up period All patients will be followed to the end of the study so that follow-up will range from 2-5 years average 35 years
On November 29 2001 the Hines Cooperative Studies Human Rights Committee and the Data and Safety Monitoring Board met to review the data from CSP 456 Both committees determined that there were sufficient data to complete the trial without enrolling any additional patients and recommended that enrollment be stopped There were no safety concerns Approximately 2165 patients of a targeted 2200 had been enrolled at this point All sites were notified of this within 24 hours of the action
Main Manuscript
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