Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique

Not Applicable

Completed

• Conditions: Hernia, Inguinal

• Registration Number: NCT05504122
• Lead Sponsor: Kocaeli Derince Education and Research Hospital

Brief Summary

Open tension-free mesh repair (Lichtenstein) and laparoscopic totally extraperitoneal (TEP) repair are the most commonly preferred techniques for inguinal hernia surgery. There's still a debate going on about which of these two techniques (open versus laparoscopic) is effective. This prospective randomized study aimed at comparing the early and long-term results of these two techniques (TEP vs. Lichtenstein).

Detailed Description

Various studies comparing the laparoscopic totally extraperitoneal (TEP) and Lichtenstein techniques have been reported. These studies have shown that TEP repair is associated with less postoperative pain and faster recovery. However, there are different views on the long-term (recurrence, chronic pain, etc.) results of the two techniques. This study was designed to compare the short- and long-term outcomes of open tension-free mesh repair technique(Lichtenstein) and laparoscopic repair technique(TEP).

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2014-12-31
• Study Completion: 2022-01-01
• Study First Submitted: 2022-07-31
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-14
• Last Update Submitted: 2022-08-14
• Study First Posted: 2022-08-17
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Patients who were diagnosed with inguinal hernia (primary, recurrent, unilateral, bilateral)
• American Society of Anesthesiologists (ASA) score of I and II
• Gave informed consent to participate in the study

Exclusion Criteria

• Patients with scrotal, strangulated, or obstructed hernia
• Periumbilical or subumbilical incision scar (median, right or left paramedian)
• Undergoing prostatectomy or abdominal bladder surgery
• Pfannenstiel incision scar
• ASA score >3

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
early recurrence rate	up to the first 3 months postoperatively	number of patients with recurrence
late recurrence rate	Postoperative 3rd to 84th month	number of patients with recurrence
postoperative complication status	up to the first 10 days postoperatively	number of patients with complications
early period complication status	up to the first 3 months postoperatively	number of patients with complications
late period complication status	Postoperative 3rd to 84th month	number of patients with complications

Secondary Outcome Measures

Name	Time	Method
Visual Analog Score for pain	postoperative 24th hour	Units on a Scale; 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-9: severe pain, 10: worst pain possible.
time to return to work after surgery	Postoperative 3rd month	day
total analgesic requirement	postoperative 1 to 10 days	the number of analgesics used.
early complication status	postoperative 1st month	Number of patients with complications