NCT05233020

Robotic Versus Hybrid Assisted Ventral Hernia Repair

Robotic Assisted vs. Laparoscopic Hybrid IPOM Ventral Hernia Repair: a Prospective Randomized Study Comparing Postoperative Outcomes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Kuopio University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Laparoscopic ventral hernia repair (LVHR) may be associated with chronic pain, seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence and poor quality of life (QoL). Our study evaluates whether robotic-assisted ventral hernia repair (rVHR) diminish these complications compared to LVHR with primary closure of the defect (hybrid).

Detailed description

Thirty patients undergoing incisional ventral hernia operation with fascial defect size from 3 to 6 cm will be recruited. Fifteen patients undergo rVHR and fifteen undergo hybrid operation.The main outcome measure is postoperative pain, evaluated with visual analogue scale (VAS: 0-10) preoperatively, at 1-week, at 1-month and at 1-year. Hernia recurrence will be evaluated with ultrasound examination at 1-year and QoL using the generic SF-36 short form questionnaire preoperatively, at 1-month and at 1-year.

Conditions

• Pain
• Quality of Life
• Recurrence

Interventions

Type	Name	Description
DEVICE	robotic	fifteen patients undergo robotic operation
DEVICE	hybrid	fifteen patients undergo hybrid operation

Timeline

• Start date: 2021-09-28
• Primary completion: 2025-11-01
• Completion: 2025-11-30
• First posted: 2022-02-10
• Last updated: 2022-02-10

Locations

1 site across 1 country: Finland