Robotic Versus Hybrid Assisted Ventral Hernia Repair | NCT05233020

Studies
Robotic Versus Hybrid Assisted Ventral Hernia Repair

NCT05233020

Sponsor

Kuopio University Hospital

Status

Unknown status

Last Update Posted

Feb 10, 2022Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Pain
Quality of Life
Recurrence

Interventions

robotic
hybrid

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 28, 2021Actual

Primary Completion Date

Nov 2025Estimated

Completion Date

Nov 30, 2025Estimated

First Submitted Date

Jan 5, 2022

First Submission Date that Met QC Criteria

Feb 9, 2022

First Posted Date

Feb 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2022

Last Update Posted Date

Feb 10, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kakela Pirjo, clinical teacher, MD, PhD, Kuopio University HospitalPrincipal Investigator

Lead Sponsor

Kuopio University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Robotic	Experimental	Fifteen patients undergo rVHR operation.	Device: robotic
hybrid	Experimental	Fifteen patients undergo hybrid operation.	Device: hybrid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
robotic	Device	fifteen patients undergo robotic operation	Robotic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ventral hernia size 3-6 cm

Exclusion Criteria:

previous ventral hernia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pirjo Käkelä, PhD	Contact	044 717 4796		pirjo.kakela@kuh.fi
Kirsi Mustonen, MD	Contact	044 717 5732		kirsi.m.mustonen@kuh.fi

Overall Officials

Name	Affiliation	Role
Pirjo Käkelä, PhD	gi -surgeon, clinical teacher	Study Director
Pirjo Käkelä, PhD	gi-surgeon, clinical teacher	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kuopio University Hospital	Recruiting	Kuopio	Northern Savonia	70200	Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D012008	Recurrence
D006555	Hernia, Ventral

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D020969	Disease Attributes

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