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Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM

NCT03283982 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-07-25

Study results available
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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.

Conditions

  • Ventral Hernia

Interventions

DEVICE

Robotic Ventral Hernia Repair with IPOM

Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform

DEVICE

Laparoscopic Ventral Hernia Repair with IPOM

Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform

Sponsors & Collaborators

  • Intuitive Surgical

    collaborator INDUSTRY

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Ajita Prabhu, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-11
Primary Completion
2021-01-31
Completion
2021-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03283982 on ClinicalTrials.gov