Robotic Versus Hybrid Assisted Ventral Hernia Repair

Not Applicable

Recruiting

• Conditions: Recurrence; Quality of Life; Pain
• Interventions: Device: robotic; Device: hybrid

• Registration Number: NCT05233020
• Lead Sponsor: Kuopio University Hospital

Brief 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.

Study Timeline

• Study Start: 2021-09-28
• Status Verified: 2022-01
• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Study First Posted: 2022-02-10
• Last Update Posted: 2022-02-10
• Primary Completion: 2025-11
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• ventral hernia size 3-6 cm

Exclusion Criteria

• previous ventral hernia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic	robotic	Fifteen patients undergo rVHR operation.
hybrid	hybrid	Fifteen patients undergo hybrid operation.

Primary Outcome Measures

Name	Time	Method
Robotic-assisted ventral hernia repair vs hybrid. Change in pain	1-year	VAS scale from 0 to 10. Zero in VAS is no pain and number ten is the highest possible pain

Secondary Outcome Measures

Name	Time	Method
Robotic-assisted ventral hernia repair vs hybrid. Change in the social functioning status.	1-year	SF-36. Scale from 0 to 100. For all scales, higher scores (100) represent better function or outcome

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Northern Savo, Finland