Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique

Hernia, Inguinal Clinical Trial

Official title:

Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique in Long-term Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05504122
• Other study ID #: KOU KAEK 2012/161-17/14
• Status: Completed
• Phase: N/A
• Start date: January 1, 2012
• Est. completion date: January 1, 2022

Study information

• Verified date: August 2022
• Source: Kocaeli Derince Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 1, 2022
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli Derince Education and Research Hospital

References & Publications (3)

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. — View 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. — View 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. Erratum in: Ann Surg. 2012 Aug;256(2):393. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative complication status	number of patients with complications	up to the first 10 days postoperatively
Primary	early period complication status	number of patients with complications	up to the first 3 months postoperatively
Primary	late period complication status	number of patients with complications	Postoperative 3rd to 84th month
Primary	early recurrence rate	number of patients with recurrence	up to the first 3 months postoperatively
Primary	late recurrence rate	number of patients with recurrence	Postoperative 3rd to 84th month
Secondary	Visual Analog Score for pain	Units on a Scale; 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-9: severe pain, 10: worst pain possible.	postoperative 24th hour
Secondary	total analgesic requirement	the number of analgesics used.	postoperative 1 to 10 days
Secondary	time to return to work after surgery	day	Postoperative 3rd month
Secondary	early complication status	Number of patients with complications	postoperative 1st month