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

NCT ID: NCT00032448

Last Updated: 2011-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-10-31
• Study Completion Date: 2004-06-30

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 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.

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 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:

Conditions

Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

1

Open and laparoscopic herniorrhaphy

Group Type: OTHER

Standardized tension-free herniorrhaphy with prosthesis

Intervention Type: PROCEDURE

Compare the effect of two typs of operative treatment of inguinal hernia.

Interventions

Standardized tension-free herniorrhaphy with prosthesis

Compare the effect of two typs of operative treatment of inguinal hernia.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Men with inguinal hernia.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

American College of Surgeons

OTHER

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Department of Veterans Affairs

Principal Investigators

Leigh A. Neumayer

Role: STUDY_CHAIR

VA Salt Lake City Health Care System, Salt Lake City

Locations

VA Medical Center, Birmingham

Birmingham, Alabama, United States

Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

No. Little Rock, Arkansas, United States

VA Medical Center, San Francisco

San Francisco, California, United States

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, United States

James A. Haley Veterans Hospital, Tampa

Tampa, Florida, United States

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, United States

VA Medical Center, Jamaica Plain Campus

Boston, Massachusetts, United States

John D. Dingell VA Medical Center, Detroit

Detroit, Michigan, United States

VA Medical Center, Durham

Durham, North Carolina, United States

WJB Dorn Veterans Hospital, Columbia

Columbia, South Carolina, United States

VA Medical Center, Memphis

Memphis, Tennessee, United States

VA North Texas Health Care System, Dallas

Dallas, Texas, United States

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, United States

VA Salt Lake City Health Care System, Salt Lake City

Salt Lake City, Utah, United States

Countries

United States

References

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(18):1819-27. doi: 10.1056/NEJMoa040093. Epub 2004 Apr 25.

Reference Type: RESULT

PMID: 15107485 (View on PubMed)

Other Identifiers

456

Identifier Type: -

Identifier Source: org_study_id