N/A N=75 Randomized Single-blind Treatment

Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM

Ventral Hernia

Bottom Line

View on ClinicalTrials.gov: NCT03283982 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

Jul 2022

Primary outcome: Primary: Postoperative Pain Scores — 5; 5; 4; 3 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Robotic Ventral Hernia Repair with IPOM (Device); Laparoscopic Ventral Hernia Repair with IPOM (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Postoperative Pain Scores	44.9; 46.3	—
PRIMARY Postoperative Pain Scores	44.9; 46.3	—
SECONDARY Number of Participants With Central Hernia Recurrence	2; 1	—
SECONDARY Cost of Robotic IPOM Versus Laparoscopic IPOM	2438; 2102	—

Summary

The investigators aim to conduct a registry-based, randomized controlled trial to investigate if the robotic platform for minimally invasive ventral hernia repair with intraperitoneal onlay mesh (IPOM), when compared to the laparoscopic platform, will influence on early postoperative pain scores, wound morbidity (surgical site infections, surgical site occurrences and surgical site occurrences requiring procedural intervention), ventral hernia recurrence rate and abdominal wall-specific quality of life.

Eligibility Criteria

Inclusion Criteria

Adult patients (>18 years old)
Primary or Incisional Ventral Hernia
Midline defect location
H. Width equal or less than 7 centimeters
Elective setting
Able to give informed consent
Able to tolerate general anesthesia
Considered eligible for minimally invasive ventral hernia repair
Willing to undergo mesh-based repair
Fascial closure is presumed to be achieved

Exclusion Criteria

Younger than 18 years old
Non-midline hernia defects
H. Width > 7cm
Emergent setting ( acute incarceration or strangulation)
Unable to give informed consent
Unable to tolerate general anesthesia
Considered not eligible for minimally invasive ventral hernia repair
Not willing to undergo mesh based repair
Fascial closure not intended or presumed not to be achieved

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03283982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.