Does Tension-Free Herniorrhaphy or Laparoscopic Herniorrhaphy Achieve Equal or Better Recurrence Rates and Lower Costs While Achieving Equivalent Outcomes for Hernia Patients?

Hernia Clinical Trial

Official title:

CSP #456 - Tension Free Inguinal Hernia Repair: Comparison of Open and Laparoscopic Surgical Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032448
• Other study ID #: 456
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2002
• Last updated: April 13, 2011
• Start date: October 1998
• Est. completion date: June 2004

Study information

• Verified date: April 2011
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 700,000 hernia repairs are performed in the U.S. each year, and this procedure accounts for 10% of all general surgery procedures in the Veterans Health Administration (VHA) (10,000 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.

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 700,000 hernia repairs are performed in the U.S. each year, and this procedure accounts for 10% of all general surgery procedures in the Veterans Health Administration (VHA) (10,000 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 3.5 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 2,165 patients of a targeted 2,200 had been enrolled at this point. All sites were notified of this within 24 hours of the action.

Main Manuscript:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2200
• Est. completion date: June 2004
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Men with inguinal hernia.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hernia

Intervention

Procedure:
• Standardized tension-free herniorrhaphy with prosthesis
Compare the effect of two typs of operative treatment of inguinal hernia.

Locations

Country	Name	City	State
United States	VA Maryland Health Care System, Baltimore	Baltimore	Maryland
United States	VA Medical Center, Birmingham	Birmingham	Alabama
United States	VA Medical Center, Jamaica Plain Campus	Boston	Massachusetts
United States	WJB Dorn Veterans Hospital, Columbia	Columbia	South Carolina
United States	VA North Texas Health Care System, Dallas	Dallas	Texas
United States	John D. Dingell VA Medical Center, Detroit	Detroit	Michigan
United States	VA Medical Center, Durham	Durham	North Carolina
United States	Michael E. DeBakey VA Medical Center (152)	Houston	Texas
United States	VA Medical Center, Memphis	Memphis	Tennessee
United States	Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock	No. Little Rock	Arkansas
United States	VA Salt Lake City Health Care System, Salt Lake City	Salt Lake City	Utah
United States	VA Medical Center, San Francisco	San Francisco	California
United States	James A. Haley Veterans Hospital, Tampa	Tampa	Florida
United States	VA Greater Los Angeles Healthcare System, West LA	West Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	American College of Surgeons

Country where clinical trial is conducted

United States, 

References & Publications (1)

Neumayer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons R Jr, Dunlop D, Gibbs J, Reda D, Henderson W; Veterans Affairs Cooperative Studies Program 456 Investigators. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med. 2004 Apr 29;350 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess recurrence rates, operative complications, pain, convalescent time, health-related quality of life, patient satisfaction, and health care utilization and costs.		Two years	No