Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair
1 other identifier
interventional
200
1 country
1
Brief Summary
Evaluate the early postoperative course of patients undergoing laparoscopic inguinal hernia repair with either a conventional or a robot assisted approach and with or without the injection of the trocar wounds with a local anesthetic.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
1 active site
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
March 19, 2019
CompletedFirst Posted
Study publicly available on registry
April 5, 2019
CompletedStudy Start
First participant enrolled
September 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
April 11, 2025
April 1, 2025
9.2 years
March 19, 2019
April 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
change in PADSS score
Time postoperative for the patient to get fit for discharge as determined by a PADSS score (Post Anesthesia Discharge Scoring System) to reach ≥ 9 (10 is maximum). The score will be taken at 2 hourly intervals after surgery (0 hours,2 hours,4 hours,6 hours,8 hours,10 hours,12 hours,14 hours,16 hours,18 hours,20 hours,22 hours,24 hours) up to 24 hours or unitl score is ≥ 9.
change of Baseline PADSS score up to 24h after surgery or unitl score is ≥ 9
Secondary Outcomes (2)
Recurrence rate
at 12 month
Quality of Life assessment: EuraHS Quality of Life questionnaire
1 month and 12 months post-operatively
Study Arms (4)
l-TAPP without local anesthetics
OTHERThese patients will undergo a laparoscopic surgery without local anaesthetics.
l-TAPP with local anesthetics
OTHERThese patients will undergo a laparoscopic surgery with local anaesthetics.
r-TAPP without local anesthetics
OTHERThese patients will undergo a robot-assisted surgery without local anaesthetics.
r-TAPP with local anesthetics
OTHERThese patients will undergo a robot-assisted surgery with local anaesthetics.
Interventions
local anesthetics will be administred
Eligibility Criteria
You may qualify if:
- adult patients presenting with a bilateral inguinal hernia planned for a minimal invasive laparoscopic repair
You may not qualify if:
- Age below 18 years
- unilateral groin hernia repair
- incarcerated hernias
- open hernia repair
- no informed consent
- pregnant women
- ASA score 4 or more
- patient included in another study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AZ Maria Middelares
Ghent, 9000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Filip Muysoms, MD,PhD
Algemeen Ziekenhuis Maria Middelares
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Surgery Department
Study Record Dates
First Submitted
March 19, 2019
First Posted
April 5, 2019
Study Start
September 23, 2019
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2029
Last Updated
April 11, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share