Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair
NCT ID: NCT03904888
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
200 participants
INTERVENTIONAL
2019-09-23
2029-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Robotic Utility for Surgical Treatment of Groin Hernias
NCT02975401
Repair of Groin Hernias After Abdominal Prostatectomy With Robotic TAPP
NCT04718597
Pain and Quality of Life After Inguinal Hernia Repair: Laparoscopic Versus Open Repair.
NCT04211142
Transabdominal Preperitoneal Inguinal Hernia Repair
NCT05839587
MRI Imaging of Ipsilateral Retromuscular Access
NCT03380312
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The introduction of mesh reinforcement for groin hernia repair has resulted in reducing the rate of recurrences and chronic pain. Moreover, laparoscopic repair techniques made it possible to place the mesh in de pre-peritoneal space by a transperitoneal (TAPP) or pre-peritoneal (TEP) approach. These minimally invasive techniques are not only associated with less chronic pain or numbness, but also with an earlier return to normal activities or work. A favor for one of the two techniques has not yet been proven.
At the Hernia Center Maria Middelares a laparoscopic transabdominal pre-peritoneal (l-TAPP) approach is favored in the majority of adult patients presenting with a groin hernia since more than 20 years. The investigators have adopted a technique using one large pre-peritoneal self-fixating mesh that covers both groins in bilateral laparoscopic repairs. In September 2016 the investigators started to use a robot assisted laparoscopic approach (r-TAPP) for groin hernia repair and built proficiency in this technique with 120 cases operated in the first year of adoption. Barriers to adopting robot assisted groin hernia repair are insufficient availability of the robot, perception of longer operative time, perceived lack of clinical benefit for the patient and increased cost for instrumentation.
In a learning curve study using the daVinci Xi robotic system the investigators have shown that after about 25 cases the skin to skin operating time for r-TAPP equals the skin to skin operating time for l-TAPP. Similarly the overall OR time (patient in and out of the OR) is not increased for r-TAPP compared to l-TAPP if the whole team including nurses and anesthetists have become proficient in robotic assisted surgery (Clinical Trials identifier: NCT0975401).
The investigators standard technique for repair of bilateral groin hernias is to use a self-fixating mesh placed in a pre-peritoneal position with a TAPP approach. The investigator prefers to use one large mesh covering the myopectineal orifice of both groins with a width of 28 cm and a length of 13 cm. The mesh used is a Progrip self-fixating mesh (Medtronic, US), which is a monofilament polyester mesh to which resorbable PLA grips have been added to fixate the mesh to the underlying tissue during the period of mesh ingrowth and incorporation. This technique has been studied in our department in a prospective study focusing on early and one year outcome and has shown favorable results (Clinical Trials identifier: NCT02525666 ).
This study aims to differentiate between the early postoperative recovery after laparoscopic repair of bilateral groin hernias treated either with r-TAPP or with l-TAPP.
A total of 200 male and female patients will be entered in the trial in Maria Middelares Ghent, for which an inclusion period of 24 months is anticipated. Patients will be screened and invited to participate at the outpatient clinic.
Study set-up:
* Based on clinical examination and/or ultrasonography 200 patients will be selected.
* Preoperative, during the outpatients' visit, patients will be asked to sign Informed Consent and to fill out the EuraHS-QoL (Quality of Life score) questionnaire.
* Patients will be randomized, to receive either conventional laparoscopic repair (100 patients) or robot assisted laparoscopic repair (100 patients). Patients will be blinded to the surgical method.
* Furthermore patients will be randomized to either receive local anesthetics (50 patients in each group) or none (50 patients in each group)
* Postoperatively, patients will be invited for clinical follow-up with quality of life evaluations with the EuraHS-QoL score at 1 month and at 12 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
l-TAPP without local anesthetics
These patients will undergo a laparoscopic surgery without local anaesthetics.
l-TAPP
Laporoscopic repair
l-TAPP with local anesthetics
These patients will undergo a laparoscopic surgery with local anaesthetics.
l-TAPP
Laporoscopic repair
local anesthetics
local anesthetics will be administred
r-TAPP without local anesthetics
These patients will undergo a robot-assisted surgery without local anaesthetics.
r-TAPP
Robot-assisted repair
r-TAPP with local anesthetics
These patients will undergo a robot-assisted surgery with local anaesthetics.
r-TAPP
Robot-assisted repair
local anesthetics
local anesthetics will be administred
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
r-TAPP
Robot-assisted repair
l-TAPP
Laporoscopic repair
local anesthetics
local anesthetics will be administred
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* unilateral groin hernia repair
* incarcerated hernias
* open hernia repair
* no informed consent
* pregnant women
* ASA score 4 or more
* patient included in another study.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Algemeen Ziekenhuis Maria Middelares
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Filip Muysoms
Head of Surgery Department
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Filip Muysoms, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Algemeen Ziekenhuis Maria Middelares
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AZ Maria Middelares
Ghent, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Coraline Study
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.