Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique

NCT ID: NCT05504122

Last Updated: 2022-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-01

Study Completion Date

2022-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hernia, Inguinal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laparoscopic Totally Extraperitoneal (TEP)

Patients who underwent Laparoscopic Totally Extraperitoneal (TEP) will be included in this group.

Group Type ACTIVE_COMPARATOR

inguinal hernia repair

Intervention Type PROCEDURE

Patients who will undergo inguinal hernia repair will be divided into two groups(TEP versus Lichtenstein) according to the technique to be applied

Open tension-free mesh repair technique (Lichtenstein)

Patients with open tension-free inguinal hernia(Lichtenstein) repair will be included in this group.

Group Type PLACEBO_COMPARATOR

inguinal hernia repair

Intervention Type PROCEDURE

Patients who will undergo inguinal hernia repair will be divided into two groups(TEP versus Lichtenstein) according to the technique to be applied

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kocaeli Derince Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Adem Yuksel

Head of Gastroenterological Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Murat Coskun, MD

Role: STUDY_DIRECTOR

Kocaeli Derince Training and Research Hospital

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20395851 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19106673 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22470068 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KOU KAEK 2012/161-17/14

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Laparoscopic Inguinal Hernia Repair TEP vs TAPP
NCT07108972 ACTIVE_NOT_RECRUITING NA