Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique
Primary Purpose
Hernia, Inguinal
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
inguinal hernia repair
Sponsored by
About this trial
This is an interventional treatment trial for Hernia, Inguinal focused on measuring hernia, laparoscopic, Lichtenstein
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Laparoscopic Totally Extraperitoneal (TEP)
Open tension-free mesh repair technique (Lichtenstein)
Arm Description
Patients who underwent Laparoscopic Totally Extraperitoneal (TEP) will be included in this group.
Patients with open tension-free inguinal hernia(Lichtenstein) repair will be included in this group.
Outcomes
Primary Outcome Measures
postoperative complication status
number of patients with complications
early period complication status
number of patients with complications
late period complication status
number of patients with complications
early recurrence rate
number of patients with recurrence
late recurrence rate
number of patients with recurrence
Secondary Outcome Measures
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.
total analgesic requirement
the number of analgesics used.
time to return to work after surgery
day
early complication status
Number of patients with complications
Full Information
NCT ID
NCT05504122
First Posted
July 31, 2022
Last Updated
August 14, 2022
Sponsor
Kocaeli Derince Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05504122
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2012 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kocaeli Derince Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
Keywords
hernia, laparoscopic, Lichtenstein
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic Totally Extraperitoneal (TEP)
Arm Type
Active Comparator
Arm Description
Patients who underwent Laparoscopic Totally Extraperitoneal (TEP) will be included in this group.
Arm Title
Open tension-free mesh repair technique (Lichtenstein)
Arm Type
Placebo Comparator
Arm Description
Patients with open tension-free inguinal hernia(Lichtenstein) repair will be included in this group.
Intervention Type
Procedure
Intervention Name(s)
inguinal hernia repair
Intervention Description
Patients who will undergo inguinal hernia repair will be divided into two groups(TEP versus Lichtenstein) according to the technique to be applied
Primary Outcome Measure Information:
Title
postoperative complication status
Description
number of patients with complications
Time Frame
up to the first 10 days postoperatively
Title
early period complication status
Description
number of patients with complications
Time Frame
up to the first 3 months postoperatively
Title
late period complication status
Description
number of patients with complications
Time Frame
Postoperative 3rd to 84th month
Title
early recurrence rate
Description
number of patients with recurrence
Time Frame
up to the first 3 months postoperatively
Title
late recurrence rate
Description
number of patients with recurrence
Time Frame
Postoperative 3rd to 84th month
Secondary Outcome Measure Information:
Title
Visual Analog Score for pain
Description
Units on a Scale; 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-9: severe pain, 10: worst pain possible.
Time Frame
postoperative 24th hour
Title
total analgesic requirement
Description
the number of analgesics used.
Time Frame
postoperative 1 to 10 days
Title
time to return to work after surgery
Description
day
Time Frame
Postoperative 3rd month
Title
early complication status
Description
Number of patients with complications
Time Frame
postoperative 1st month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat Coskun, MD
Organizational Affiliation
Kocaeli Derince Training and Research Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20395851
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.
Results Reference
background
PubMed Identifier
19106673
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.
Results Reference
background
PubMed Identifier
22470068
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.
Results Reference
background
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Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique
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