NCT05504122

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

July 31, 2022

Last Update Submit

August 14, 2022

Conditions

Hernia, Inguinal

Keywords

hernialaparoscopicLichtenstein

Outcome Measures

Primary Outcomes (5)

  • postoperative complication status

    number of patients with complications

    up to the first 10 days postoperatively

  • early period complication status

    number of patients with complications

    up to the first 3 months postoperatively

  • late period complication status

    number of patients with complications

    Postoperative 3rd to 84th month

  • early recurrence rate

    number of patients with recurrence

    up to the first 3 months postoperatively

  • late recurrence rate

    number of patients with recurrence

    Postoperative 3rd to 84th month

Secondary Outcomes (4)

  • Visual Analog Score for pain

    postoperative 24th hour

  • total analgesic requirement

    postoperative 1 to 10 days

  • time to return to work after surgery

    Postoperative 3rd month

  • early complication status

    postoperative 1st month

Study Arms (2)

Laparoscopic Totally Extraperitoneal (TEP)

ACTIVE COMPARATOR

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

Procedure: inguinal hernia repair

Open tension-free mesh repair technique (Lichtenstein)

PLACEBO COMPARATOR

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

Procedure: inguinal hernia repair

Interventions

inguinal hernia repairPROCEDURE

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

Laparoscopic Totally Extraperitoneal (TEP)Open tension-free mesh repair technique (Lichtenstein)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 20395851BACKGROUND

  • 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.

    PMID: 19106673BACKGROUND

  • 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.

    PMID: 22470068BACKGROUND

MeSH Terms

Conditions

Hernia, InguinalHernia

Condition Hierarchy (Ancestors)

Hernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Murat Coskun, MD

    Kocaeli Derince Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Gastroenterological Surgery

Study Record Dates

First Submitted

July 31, 2022

First Posted

August 17, 2022

Study Start

January 1, 2012

Primary Completion

December 31, 2014

Study Completion

January 1, 2022

Last Updated

August 17, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share