Minimal ACCess Hernia InguinAlis Treatment of Hernia
ConditionInguinal 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: single-port robotic suprapubic inguinal hernia repair (SPIN procedure).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults with a primary inguinal hernia, either unilateral or bilateral
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
single-port robotic suprapubic inguinal hernia repair
Procedure/Surgerysingle-port robotic suprapubic inguinal hernia repair
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: single-port robotic suprapubic inguinal hernia repairExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Operative time
Total operative time from skin incision to skin closure
Time frame
During surgery2
Technical errors with the robotic system
Number and type of technical errors or device-related issues encountered during the procedure.
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 postoperativelySecondary 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
hernia recurrence
Presence of recurrent hernia assessed clinically and confirmed by ultrasound when clinically indicated.
Time frame
1 year postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov