Robotic Minimally Invasive Ventral Hernia Repair With DEXTER

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

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-11

Study Completion Date

2026-01-15

Brief Summary

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The aim of this clinical investigation is to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing incisional or primary ventral hernia repair.

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Detailed Description

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Conditions

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Ventral Hernia Repair

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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ventral hernia repair

Robotic-assisted incisional or primary ventral hernia repair with the DEXTER robotic surgery system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Aged \> 18 years
* Planned to undergo incisional and primary midline ventral (M2-M4; epigastric, umbilical and infraumbilical) hernia repair smaller and equal to 8cm
* Patient agrees to perform the 30-day follow-up assessment, as per standard of care

Exclusion Criteria

* Any planned concomitant procedures
* Active anticoagulant treatment
* Recurring hernia with mesh during primary hernia repair
* Need for transversal abdominal release
* Patients under corticosteroids or other immunosuppressive treatment
* Loss of domain type of hernia
* Previous incision extending from xiphoid process to pubic bone (= Median laparotomy M1 to M5)
* M2 hernia extending to M1 and/or M4 hernia extending to M5
* Ongoing intra-abdominal infection or septic state
* Abdominal fistulae
* History of major\* abdominal or pelvic surgery

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No