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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05472987
Other study ID # 22-591
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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