Lichtenstein Versus TAPP and TEP in Groin Hernioplasty
TAPP&TEP
Comparison of Lichtenstein Versus TAPP and TEP Techniques for Inguinal Hernia Repair
1 other identifier
interventional
150
0 countries
N/A
Brief Summary
The aim of the study is to evaluate the effectiveness of various methods of inguinal hernia repair and to evaluate techniques of synthetic mesh fixation during laparoscopic and open hernia repair.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2016
CompletedFirst Posted
Study publicly available on registry
October 10, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedOctober 10, 2016
October 1, 2016
1.4 years
October 6, 2016
October 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-operative complications associated with wound
Wound infection with or without the need to remove the mesh, Wound necrosis, Hematoma or seroma in the wound.
30 days after surgery
Secondary Outcomes (1)
The frequency of conversions (from laparoscopic to open approach)
1 year
Other Outcomes (2)
Evaluation of the severity of pain according to VAS (visual analogue scale)
1 year after surgery
Quality of life.
Prior to surgery, 1 and 6 months after the operation using SF-36 questionnaire.
Study Arms (3)
Lichtenstein technique
ACTIVE COMPARATORLichtenstein inguinal hernia repair
TAPP
ACTIVE COMPARATORTransabdominal preperitoneal (TAPP) approach for inguinal hernia repair
TEP
ACTIVE COMPARATORTotally extraperitoneal (TEP) approach for inguinal hernia repair
Interventions
Eligibility Criteria
You may qualify if:
- male
- age: 18 - 65
- planned inguinal hernia repair using synthetic implant
- BMI range: 20-35 kg / m2
- written informed consent
You may not qualify if:
- prior midline laparotomy
- contraindications for general anaesthesia
- ASA \> IV
- cirrhosis (Child B or C) or ascites
- active treatment with use of chemiotherapy
- incarcerated hernia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Miroslaw Szuralead
- Jagiellonian Universitycollaborator
- Holy Jan Grande Boni Fratres Hospital in Krakowcollaborator
- Stefan Zeromski Hospital in Krakówcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Miroslaw Szura, MD, PhD
Department of Experimental and Clinical Surgery, Jagiellonian University Medical College
- PRINCIPAL INVESTIGATOR
Rafal Solecki, MD, PhD
Department of Experimental and Clinical Surgery, Jagiellonian University Medical College
- PRINCIPAL INVESTIGATOR
Artur Pasternak, MD,PhD
Department of Anatomy, Jagiellonian University Medical College
- PRINCIPAL INVESTIGATOR
Jakub Łomnicki, MD
Stefan Zeromski Hospital in Krakow
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 6, 2016
First Posted
October 10, 2016
Study Start
January 1, 2017
Primary Completion
June 1, 2018
Study Completion
December 1, 2019
Last Updated
October 10, 2016
Record last verified: 2016-10