Robotic Versus Open Ventral Hernia Repair

Ventral Hernia Clinical Trial

— ROVHR  

Official title:

Robotic Versus Open Ventral Hernia Repair: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472987
• Other study ID #: 22-591
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: August 1, 2025

Study information

• Verified date: August 2023
• Source: The Cleveland Clinic
• Contact: Lucas Beffa, MD
• Phone: 216-445-5975
• Email: beffal[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair.

Description:

This is a randomized trial comparing open retromuscular ventral hernia repair to robotic retromuscular ventral hernia repair. This is a superiority trial with a primary outcome of length of stay in the hospital, theorizing that robotic retromuscular ventral hernia repairs are superior to open ventral hernia repairs by reducing length of stay by 24 hours. Patients will be blinded to the intervention, groups will be in parallel, and the primary outcome (when the patient is discharged) will be determined by a blinded assessor.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older

• 7 cm to 15 cm wide hernia midline defects

• BMI less than or equal to 45

• Patient deemed both an open and robotic candidate by operating surgeon

Exclusion Criteria:

• 17 years old or younger

• prisoners

• pregnant patients

• Emergent patients

• BMI greater than 45

• Hernia defects less than 7 cm or greater than 15 cm in width

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Procedure:
• Ventral Hernia Repair
Patients will undergo retromuscular ventral hernia repair

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Lucas Beffa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Stay	Time in the hospital after the surgery	30 days
Secondary	Post-operative wound complications	any abnormal wound healing	30 day and one year
Secondary	Other post operative complications	Heart attacks, acute kidney injury, admissions to ICU, respiratory failure	30 days
Secondary	Readmission rate	Readmission to the hospital within 30 days of the surgery	30 days
Secondary	Opioid consumption	Opioid prescribed and consumed	30 days and one year
Secondary	Acute pain scores	Numeric Rating Scale-11 pain scores daily, 0-10 with 0 being no pain and 10 being the worst pain for first five days after surgery	5 days after surgery
Secondary	Hernia Related Specific Quality of Life Score	Score of 0-100 with lower scores indicating worse quality of life	30 days and one year
Secondary	Direct cost	Cost to the hospital	30 days
Secondary	Hernia recurrence	Hernia recurrence	30 days and one year
Secondary	Quality of life scores using European Hernia Society (EuraHS) scale	EuraHS is a hernia specific quality of life scale with three domains: pain, restrictions of activity, and cosmesis. 0-30 with higher scores indicating a worse quality of life.	30 day and one year