Health TrialsbyHealthPanel

Robotic Single Port Ventral Hernia Repair

ConditionVentral Hernia Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlgemeen Ziekenhuis Maria Middelares

About this trial

Evaluation of the perioperative outcomes of robotic suprapubic ventral hernia repair with the Da Vinci Singe Port (SP) system

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults with a primary midline ventral (umbilical or epigastric) classified as M1-M4 according to EHS classification with or without concomitant diastasis of the rectus abdominis muscles

Disqualifiers

Post-prostatectomy

Post-preperitoneal mesh operation for inguinal hernia

Laparotomy in the lower abdomen

Caesarean section

Trial design

Design model

Single group

Treatments tested in this trial

  • SP2 eTEP

    Procedure/Surgery

    Participants undergo robotic suprapubic ventral hernia repair using the SP2 eTEP (suprapubic extraperitoneal single-port enhanced-view totally extraperitoneal) technique with the da Vinci Single Port surgical system. The procedure includes extraperitoneal mesh placement for repair of primary ventral hernias, with or without concomitant diastasis repair.

  • da Vinci Single Port Surgical System

    Device

    Robotic surgical platform used to perform the SP2 eTEP ventral hernia repair procedure through a single suprapubic incision.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Robotic Suprapubic Ventral Hernia Repair (SP2 eTEP)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Operative Time

Duration of the robotic suprapubic ventral hernia repair procedure.

Time frame
During surgery
2

Technical Errors With the Robotic System

Number and type of technical errors or device-related issues encountered during the procedure.

Time frame
During surgery
3

Complication Rate

Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification.

Time frame
From surgery until 1 month postoperatively

Secondary 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 postoperatively
2

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 following robotic ventral hernia repair.

Time frame
Preoperatively, 1 month postoperatively, and 1 year postoperatively
3

Hernia Recurrence Rate

Presence of recurrent ventral hernia assessed clinically and confirmed by ultrasound when clinically indicated.

Time frame
1 year postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Algemeen Ziekenhuis Maria Middelares

Lead sponsor

Source ClinicalTrials.gov
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