Robotic Versus Hybrid Assisted Ventral Hernia Repair (ROHYB)

February 9, 2022 updated by: Kakela Pirjo, Kuopio University Hospital

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
    • Northern Savo
      • Kuopio, Northern Savo, Finland, 70200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ventral hernia size 3-6 cm

Exclusion Criteria:

  • previous ventral hernia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotic
Fifteen patients undergo rVHR operation.
Device: robotic
fifteen patients undergo robotic operation
Experimental: hybrid
Fifteen patients undergo hybrid operation.
Device: hybrid
fifteen patients undergo hybrid operation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Investigators

  • Study Director: Pirjo Käkelä, PhD, gi -surgeon, clinical teacher
  • Principal Investigator: Pirjo Käkelä, PhD, gi-surgeon, clinical teacher

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2021

Primary Completion (Anticipated)

November 1, 2025

Study Completion (Anticipated)

November 30, 2025

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 10, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5200662

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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