OBJECTIVE: To compare laparoscopic with open hernia repair in a randomized clinical trial at a median follow-up of 5 years. SUMMARY BACKGROUND DATA: Follow-up of patients in clinical trials evaluating laparoscopic hernia repair has been short. METHODS: Of 379 consecutive patients admitted for surgery under the care of one surgeon, 300 were randomized tototally extraperitoneal hernia repair or open repair, with the open operation individualized to the patient's age and hernia type. All patients, both randomized and nonrandomized, were followed up by clinical examination annually by an independent observer. RESULTS:Recurrence rates were similar for both randomized groups. In 1 of the 79 nonrandomized patients, a recurrent hernia developed. Groin or testicular pain was the most common symptom on follow-up of randomized patients. The most common reason for reoperation was development of a contralateral hernia, which was noted in 9% of patients; 11% of all patients died on follow-up, mainly as a result of cardiovascular disease or cancer. CONCLUSIONS: These data show a similar outcome for laparoscopic and open hernia repair, and both procedures have a place in managing this common problem.
RCT Entities:
OBJECTIVE: To compare laparoscopic with open hernia repair in a randomized clinical trial at a median follow-up of 5 years. SUMMARY BACKGROUND DATA: Follow-up of patients in clinical trials evaluating laparoscopic hernia repair has been short. METHODS: Of 379 consecutive patients admitted for surgery under the care of one surgeon, 300 were randomized to totally extraperitoneal hernia repair or open repair, with the open operation individualized to the patient's age and hernia type. All patients, both randomized and nonrandomized, were followed up by clinical examination annually by an independent observer. RESULTS: Recurrence rates were similar for both randomized groups. In 1 of the 79 nonrandomized patients, a recurrent hernia developed. Groin or testicular pain was the most common symptom on follow-up of randomized patients. The most common reason for reoperation was development of a contralateral hernia, which was noted in 9% of patients; 11% of all patients died on follow-up, mainly as a result of cardiovascular disease or cancer. CONCLUSIONS: These data show a similar outcome for laparoscopic and open hernia repair, and both procedures have a place in managing this common problem.