Robotic Versus Hybrid Assisted Ventral Hernia Repair

NCT ID: NCT05233020

Last Updated: 2022-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-28

Study Completion Date

2025-11-30

Brief Summary

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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

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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.

Conditions

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Pain Quality of Life Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Robotic

Fifteen patients undergo rVHR operation.

Group Type EXPERIMENTAL

robotic

Intervention Type DEVICE

fifteen patients undergo robotic operation

hybrid

Fifteen patients undergo hybrid operation.

Group Type EXPERIMENTAL

hybrid

Intervention Type DEVICE

fifteen patients undergo hybrid operation

Interventions

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robotic

fifteen patients undergo robotic operation

Intervention Type DEVICE

hybrid

fifteen patients undergo hybrid operation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ventral hernia size 3-6 cm

Exclusion Criteria

* previous ventral hernia
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kakela Pirjo

clinical teacher, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pirjo Käkelä, PhD

Role: STUDY_DIRECTOR

gi -surgeon, clinical teacher

Pirjo Käkelä, PhD

Role: PRINCIPAL_INVESTIGATOR

gi-surgeon, clinical teacher

Locations

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Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Pirjo Käkelä, PhD

Role: CONTACT

044 717 4796

Kirsi Mustonen, MD

Role: CONTACT

044 717 5732

Facility Contacts

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Pirjo Käkelä, PhD

Role: primary

044 717 4796

Kirsi Mustonen, MD

Role: backup

044 717 5732

Other Identifiers

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5200662

Identifier Type: -

Identifier Source: org_study_id

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