Clinical trial NCT05504122: Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique
Official title: Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique in Long-term Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Inguinal
Keywords: hernia
laparoscopic
Lichtenstein
Lead sponsor: Kocaeli Derince Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: postoperative complication status
timeFrame: up to the first 10 days postoperatively
measure: early period complication status
timeFrame: up to the first 3 months postoperatively
measure: late period complication status
timeFrame: Postoperative 3rd to 84th month
measure: early recurrence rate
timeFrame: up to the first 3 months postoperatively
measure: late recurrence rate
timeFrame: Postoperative 3rd to 84th month
Secondary outcomes:
measure: Visual Analog Score for pain
timeFrame: postoperative 24th hour
measure: total analgesic requirement
timeFrame: postoperative 1 to 10 days
measure: time to return to work after surgery
timeFrame: Postoperative 3rd month
measure: early complication status
timeFrame: postoperative 1st month
Other outcomes:
Locations:
Study officials:
affiliation: Kocaeli Derince Training and Research Hospital
name: Murat Coskun, MD
role: STUDY_DIRECTOR
References:
citation: Langeveld HR, van't Riet M, Weidema WF, Stassen LP, Steyerberg EW, Lange J, Bonjer HJ, Jeekel J. Total extraperitoneal inguinal hernia repair compared with Lichtenstein (the LEVEL-Trial): a randomized controlled trial. Ann Surg. 2010 May;251(5):819-24. doi: 10.1097/SLA.0b013e3181d96c32.
citation: Eklund AS, Montgomery AK, Rasmussen IC, Sandbue RP, Bergkvist LA, Rudberg CR. Low recurrence rate after laparoscopic (TEP) and open (Lichtenstein) inguinal hernia repair: a randomized, multicenter trial with 5-year follow-up. Ann Surg. 2009 Jan;249(1):33-8. doi: 10.1097/SLA.0b013e31819255d0.
citation: O'Reilly EA, Burke JP, O'Connell PR. A meta-analysis of surgical morbidity and recurrence after laparoscopic and open repair of primary unilateral inguinal hernia. Ann Surg. 2012 May;255(5):846-53. doi: 10.1097/SLA.0b013e31824e96cf.