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Robotic Versus Hybrid Assisted Ventral Hernia Repair (ROHYB)

Primary Purpose

Pain, Quality of Life, Recurrence

Status

Recruiting

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

robotic

hybrid

About this trial

This is an interventional treatment trial for Pain focused on measuring Ventral hernia, Laparoscopy, Robot-assisted, pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

ventral hernia size 3-6 cm

Exclusion Criteria:

previous ventral hernia

Sites / Locations

Kuopio University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Robotic

hybrid

Arm Description

Fifteen patients undergo rVHR operation.

Fifteen patients undergo hybrid operation.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05233020

First Posted

January 5, 2022

Last Updated

February 9, 2022

Sponsor

Kuopio University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05233020

Brief Title

Robotic Versus Hybrid Assisted Ventral Hernia Repair

Acronym

ROHYB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 28, 2021 (Actual)

Primary Completion Date

November 2025 (Anticipated)

Study Completion Date

November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kuopio University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Quality of Life, Recurrence

Keywords

Ventral hernia, Laparoscopy, Robot-assisted, pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Robotic

Arm Type

Experimental

Arm Description

Fifteen patients undergo rVHR operation.

Arm Title

hybrid

Arm Type

Experimental

Arm Description

Fifteen patients undergo hybrid operation.

Intervention Type

Device

Intervention Name(s)

robotic

Intervention Description

fifteen patients undergo robotic operation

Intervention Type

Device

Intervention Name(s)

hybrid

Intervention Description

fifteen patients undergo hybrid operation

Primary Outcome Measure Information:

Title

Robotic-assisted ventral hernia repair vs hybrid. Change in pain

Description

VAS scale from 0 to 10. Zero in VAS is no pain and number ten is the highest possible pain

Time Frame

1-year

Secondary Outcome Measure Information:

Title

Robotic-assisted ventral hernia repair vs hybrid. Change in the social functioning status.

Description

SF-36. Scale from 0 to 100. For all scales, higher scores (100) represent better function or outcome

Time Frame

1-year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ventral hernia size 3-6 cm Exclusion Criteria: previous ventral hernia

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pirjo Käkelä, PhD

Phone

044 717 4796

pirjo.kakela@kuh.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Kirsi Mustonen, MD

Phone

044 717 5732

kirsi.m.mustonen@kuh.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pirjo Käkelä, PhD

Organizational Affiliation

gi -surgeon, clinical teacher

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Pirjo Käkelä, PhD

Organizational Affiliation

gi-surgeon, clinical teacher

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kuopio University Hospital

City

Kuopio

State/Province

Northern Savo

ZIP/Postal Code

70200

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pirjo Käkelä, PhD

Phone

044 717 4796

pirjo.kakela@kuh.fi

First Name & Middle Initial & Last Name & Degree

Kirsi Mustonen, MD

Phone

044 717 5732

kirsi.m.mustonen@kuh.fi

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Robotic Versus Hybrid Assisted Ventral Hernia Repair

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