NCT05233020

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

4.1 years

First QC Date

January 5, 2022

Last Update Submit

February 9, 2022

Conditions

PainQuality of LifeRecurrence

Keywords

Ventral herniaLaparoscopyRobot-assistedpain

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

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

    1-year

Study Arms (2)

Robotic

EXPERIMENTAL

Fifteen patients undergo rVHR operation.

Device: robotic

hybrid

EXPERIMENTAL

Fifteen patients undergo hybrid operation.

Device: hybrid

Interventions

roboticDEVICE

fifteen patients undergo robotic operation

Robotic
hybridDEVICE

fifteen patients undergo hybrid operation

hybrid

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ventral hernia size 3-6 cm

You may not qualify if:

  • previous ventral hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70200, Finland

RECRUITING

MeSH Terms

Conditions

PainRecurrenceHernia, Ventral

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesHernia, AbdominalHerniaPathological Conditions, Anatomical

Study Officials

  • Pirjo Käkelä, PhD

    gi -surgeon, clinical teacher

    STUDY DIRECTOR

  • Pirjo Käkelä, PhD

    gi-surgeon, clinical teacher

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pirjo Käkelä, PhD

CONTACT

044 717 4796pirjo.kakela@kuh.fi

Kirsi Mustonen, MD

CONTACT

044 717 5732kirsi.m.mustonen@kuh.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical teacher, MD, PhD

Study Record Dates

First Submitted

January 5, 2022

First Posted

February 10, 2022

Study Start

September 28, 2021

Primary Completion

November 1, 2025

Study Completion

November 30, 2025

Last Updated

February 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)