Robotic Versus Hybrid Assisted Ventral Hernia Repair

Pain Clinical Trial

— ROHYB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05233020
• Other study ID #: 5200662
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: November 30, 2025

Study information

• Verified date: January 2022
• Source: Kuopio University Hospital
• Contact: Pirjo Käkelä, PhD
• Phone: 044 717 4796
• Email: pirjo.kakela[@]kuh.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• ventral hernia size 3-6 cm

Exclusion Criteria:

• previous ventral hernia

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Pain
• Quality of Life
• Recurrence

Intervention

Device:
• robotic
fifteen patients undergo robotic operation
• hybrid
fifteen patients undergo hybrid operation

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio	Northern Savo

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Robotic-assisted ventral hernia repair vs hybrid. Change in pain	VAS scale from 0 to 10. Zero in VAS is no pain and number ten is the highest possible pain	1-year
Secondary	Robotic-assisted ventral hernia repair vs hybrid. Change in the social functioning status.	SF-36. Scale from 0 to 100. For all scales, higher scores (100) represent better function or outcome	1-year