Robotic Single Port Combined Umbilical and Inguinal Hernia Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlgemeen Ziekenhuis Maria Middelares
About this trial
Evaluation of the perioperative and patient reported outcomes of a new surgical technique: robotic inguinal hernia repair using the Da Vinci SP system.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults with a primary inguinal hernia, either unilateral or bilateral, in association with a primary umbilical hernia of >1
Disqualifiers
recurrent inguinal hernia after preperitoneal repair
irreducible scrotal hernia
post-prostatectomy
laparotomy in the lower abdomen
Trial design
Design model
Single group
Treatments tested in this trial
da Vinci Single Port Surgical System
DeviceRobotic surgical platform used to perform single-port robotic inguinal hernia repair with concomitant umbilical hernia repair through a single umbilical access site.
Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair
Procedure/SurgeryRobotic single-port inguinal hernia repair with concomitant umbilical hernia repair through a single umbilical access site using the da Vinci SP system.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Robotic Single-Port Inguinal and Concomitant Umbilical Hernia RepairExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Technical errors with the robotic system
Number and type of technical errors or device-related issues encountered during the procedure.
Time frame
During surgery2
Operative time
Total operative time from skin incision to skin closure
Time frame
During surgery3
Complication Rate
Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification
Time frame
From surgery until 1 month postoperatively4
Success rate
success rate of preperitoneal mesh placement
Time frame
From surgery until planned follow-up 1 month potoperativelySecondary outcomes
1
EuraHS Quality of Life score
Patient-reported quality of life assessed using the European Registry for Abdominal Wall Hernias Quality of Life (EuraHS-QoL) Questionnaire, a validated instrument evaluating pain at the hernia site, restriction of activities, and cosmetic discomfort. The total EuraHS-QoL score ranges from 0 to 90, with lower scores indicating better quality of life and less symptom burden, and higher scores indicating worse quality of life and greater symptom burden
Time frame
Preoperatively, 1 month and 1 year postoperatively2
Body Image Questionnaire Score
Patient-reported body image assessed using the Body Image Questionnaire. The questionnaire evaluates patient satisfaction with physical appearance and cosmetic outcomes
Time frame
Preoperatively, 1 month , and 1 year postoperatively3
Number of Participants With Hernia Recurrence
Number of participants with a recurrent ventral hernia within 1 year after surgery. Hernia recurrence will be assessed clinically and confirmed by ultrasound when clinically indicated.
Time frame
1 year postoperativelySponsors and contacts
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Source ClinicalTrials.gov