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
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-09-15
2025-12-31
Brief Summary
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Researchers will compare to the operative time for rTAPP of 50 patients by the same surgeon in another hospital using the daVinci Xi (Intuitive Surgical) robotic system.
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Detailed Description
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To evaluate the evolution of the operative time in performing robotic assisted laparoscopic inguinal hernia repair (rTAPP) during the learning curve of the first 50 patients using the HugoTM Ras (Medtronic) robotic system using the setup guide at the Sint Vincentius Hospital in Deinze. This will be compared to the operative time for rTAPP of 50 patients by the same surgeon in General hospital Maria Middelares using the daVinci Xi (Intuitive Surgical) robotic system.
Patient data and outcome data will be collected. A follow-up of 1 month postoperative is foreseen for the evaluation of short-term complications and quality of life 1 month after surgery.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HugoTM Ras (Medtronic) robotic system
The patient is positioned supine position and a tilt of Trendelenburg of 12 degrees is given. A Verres needle insufflation at Palmers' point at the left subcostal margin will be done to achieve a pneumoperitoneum of 12 mmHg. Subsequently, a trocar of 12 mm is placed at the upper margin of the umbilicus using an optical trocar. Two further trocars of 8 mm are placed left and right side at 7 to 8 cm distance from the umbilical trocar and 2 cm caudal from the umbilical trocar. The setup of the arms, tilt and angles are done using the setup guide. The operation is performed using a scope with a 0°-degree angle. As instruments we have a fenestrated bipolar forceps in the left hand and a monopolar curved scissors in the right hand. Mesh used will be DextileTM Anatomical Mesh X-Large of 16x12 cm. There is a left sided and a right sided version and in bilateral hernias the meshes will overlap on the midline. The peritoneum is closed using a barbed suture (V-Loc 3/0) of 15 cm in length.
robotic surgical platform
robot-assisted laparoscopic inguinal hernia repair (rTAR)
daVinci Xi (Intuitive Surgical) robotic system
An 8-mm trocar will be placed at the supraumbilical position after creation of pneumoperitoneum using a Verress needle with an intra-abdominal pressure of 12 mmHg. Two additional trocars (8 mm) are placed bilaterally in the flank at the level of the umbilicus under direct vision. The distance between the lateral trocars and the umbilical trocar will be 7 cm at minimum. The Progrip™ Laparoscopic Self-Fixating Mesh of 12×16 cm (anatomic version, Medtronic, Minneapolis, MN, US) will be used. The suture will be a slowly absorbable barbed suture 15 cm in length (V-Loc™ 90, Medtronic, Minneapolis, MN, US). The trocars are docked to the robotic arms, with the endoscope at the umbilicus. Inguinal hernia repair will be performed according to the standard surgical principle.
robotic surgical platform
robot-assisted laparoscopic inguinal hernia repair (rTAR)
Interventions
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robotic surgical platform
robot-assisted laparoscopic inguinal hernia repair (rTAR)
Eligibility Criteria
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Exclusion Criteria
* Inguinal hernias after abdominal prostatectomy.
* Pregnancy.
* Emergency surgery.
* Age below 18 years.
* Absence of informed consent.
18 Years
ALL
Yes
Sponsors
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Algemeen Ziekenhuis Maria Middelares
OTHER
Responsible Party
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Filip Muysoms
Principal Investigator
Locations
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AZ Sint-Vincentius
Deinze, , Belgium
AZ Maria Middelares
Ghent, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Filip Muysoms, MD, PhD
Role: backup
Filip Muysoms, MD, PhD
Role: backup
Other Identifiers
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SUSHI
Identifier Type: -
Identifier Source: org_study_id
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