Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Laparoscopic Totally Extraperitoneal (TEP) Patients who underwent Laparoscopic Totally Extraperitoneal (TEP) will be included in this group. |
Procedure: inguinal hernia repair
Patients who will undergo inguinal hernia repair will be divided into two groups(TEP versus Lichtenstein) according to the technique to be applied
|
| Placebo Comparator: Open tension-free mesh repair technique (Lichtenstein) Patients with open tension-free inguinal hernia(Lichtenstein) repair will be included in this group. |
Procedure: inguinal hernia repair
Patients who will undergo inguinal hernia repair will be divided into two groups(TEP versus Lichtenstein) according to the technique to be applied
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Secondary Outcome Measures
- 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.
- total analgesic requirement [postoperative 1 to 10 days]
the number of analgesics used.
- time to return to work after surgery [Postoperative 3rd month]
day
- early complication status [postoperative 1st month]
Number of patients with complications
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who were diagnosed with inguinal hernia (primary, recurrent, unilateral, bilateral)
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American Society of Anesthesiologists (ASA) score of I and II
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Gave informed consent to participate in the study
Exclusion Criteria:
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Patients with scrotal, strangulated, or obstructed hernia
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Periumbilical or subumbilical incision scar (median, right or left paramedian)
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Undergoing prostatectomy or abdominal bladder surgery
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Pfannenstiel incision scar
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ASA score >3
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kocaeli Derince Education and Research Hospital
Investigators
- Study Director: Murat Coskun, MD, Kocaeli Derince Training and Research Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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. Erratum in: Ann Surg. 2012 Aug;256(2):393.
- KOU KAEK 2012/161-17/14