Robotic Versus Open Ventral Hernia Repair
ConditionVentral Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLucas Beffa
About this trial
This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 years and older
7 cm to 15 cm wide hernia midline defects
BMI less than or equal to 45
Patient deemed both an open and robotic candidate by operating surgeon
Disqualifiers
17 years old or younger
prisoners
pregnant patients
Emergent patients
Trial design
Design model
Parallel
Treatments tested in this trial
Ventral Hernia Repair
Procedure/SurgeryPatients will undergo retromuscular ventral hernia repair
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Open Ventral Hernia RepairActive comparator 1 intervention
Group B: Robotic Ventral Hernia RepairActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Length of Stay
Time in the hospital after the surgery
Time frame
30 daysSecondary outcomes
1
Post-operative wound complications
any abnormal wound healing
Time frame
30 day and one year2
Other post operative complications
Heart attacks, acute kidney injury, admissions to ICU, respiratory failure
Time frame
30 days3
Readmission rate
Readmission to the hospital within 30 days of the surgery
Time frame
30 days4
Opioid consumption
Opioid prescribed and consumed
Time frame
30 days and one yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lucas Beffa
Lead sponsor
The Cleveland Clinic
Sponsor institution
Source ClinicalTrials.gov