Actively Recruiting
Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair comparing early recovery and postoperative outcomes
Led by Algemeen Ziekenhuis Maria Middelares · Updated on 2025-04-11
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Inguinal hernia is a common condition with a high lifetime risk, especially in men. Researchers are studying the early recovery after laparoscopic inguinal hernia repair using either a conventional laparoscopic method (l-TAPP) or a robot-assisted laparoscopic method (r-TAPP). The study focuses on patients with bilateral groin hernias and aims to compare outcomes such as recovery and quality of life after surgery. Participants will be randomly assigned to one of four groups: conventional laparoscopic repair with or without local anesthetics, and robot-assisted laparoscopic repair with or without local anesthetics. The study uses a self-fixating mesh placed via a laparoscopic transabdominal pre-peritoneal approach. The robot-assisted technique has been used since 2016, and this trial will further assess its early postoperative effects compared to the conventional method. Participants will complete quality of life questionnaires before surgery, and at one month and twelve months after surgery. The main outcome measured is the change in the Post Anesthetic Discharge Scoring System (PADSS) score within 24 hours after surgery or until a score of 9 or higher is reached. Researchers will also monitor recurrence rates at 12 months and assess quality of life during follow-up visits. The total study duration is expected to last until December 2029.
CONDITIONS
Brief Title
Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients presenting with a bilateral inguinal hernia planned for a minimally invasive laparoscopic repair
You will not qualify if you...
- Age below 18 years
- Unilateral groin hernia repair
- Incarcerated hernias
- Open hernia repair
- No informed consent
- Pregnant women
- ASA score of 4 or more
- Patient included in another study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo either conventional laparoscopic or robot-assisted laparoscopic bilateral inguinal hernia repair with or without local anesthetics.
1 surgical visit (in-person)
Duration - 12 months
Participants attend follow-up visits for clinical evaluation and quality of life assessments using the EuraHS-QoL questionnaire.
2 visits at 1 month and 12 months (in-person)
Trial Site Locations
Total: 1 location
1
AZ Maria Middelares
Ghent, Belgium, 9000
Actively Recruiting
Research Team
F
Filip Muysoms, MD,PhD
R
Rita Baumgartner, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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