NCT05906017

Brief Summary

In this randomized clinical trial, the investigators will compare the conventional open repair for hernia in the anterior abdominal wall with the robotic-assisted approach. 60 patients with midline abdominal wall defects will be randomized to either open or robotic-assisted surgery. The investigators will examine short and long-term complications through follow-up with clinical assessment as well as patient-reported outcome measures including pain, cosmetic appearance, and overall patient satisfaction. Furthermore, the investigators will study the difference in surgical stress response between the two methods measured from a variety of different biomarkers before and after the operation. A cost-effective analysis will be conducted for the robotic and open procedure.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

1.9 years

First QC Date

May 23, 2023

Last Update Submit

July 11, 2025

Conditions

Abdominal Hernia

Keywords

Da VinciRobotUmbilical herniaVentral herniaEpigastric herniaHernia repairLaparotomy

Outcome Measures

Primary Outcomes (1)

  • Length of stay (LOS)

    The primary outcome measure will be assessed by reviewing the electronic patient journal system. The day of the procedure will be recorded as day 0

    Up until 3 months

Secondary Outcomes (7)

  • Operating time

    Time from first incision to wound closure

  • Change in Surgical stress response (CRP)

    measured at baseline preoperatively, 30 minutes after extubation, 120 minutes after extubation and on day 1 and 3.

  • Hernia defect size

    Measured preoperatively

  • Intraoperative need of blood transfusion

    From first incision until last suture has been placed

  • Change in surgical stress response (Interleukins)

    Measured at baseline preoperatively and up until 120 minutes after extubation on day 1 and 3.

  • +2 more secondary outcomes

Study Arms (2)

Open repair

ACTIVE COMPARATOR

Open ventral hernia repair

Procedure: Open Hernia surgery

Robotic-assisted repair

EXPERIMENTAL

Robotic-assisted ventral hernia repair

Procedure: Robotic Hernia surgery

Interventions

Open Hernia surgeryPROCEDURE

midline ventral hernia repair - open

Open repair
Robotic Hernia surgeryPROCEDURE

midline ventral hernia repair - robotic

Robotic-assisted repair

Eligibility Criteria

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

You may qualify if:

  • Age≥18
  • ASA 1-3
  • Clinical and radiologic diagnosis of midline ventral hernia
  • Eligible to surgery according to a preoperative anaesthetic assessment
  • Informed consent
  • Able to understand written and oral Danish language

You may not qualify if:

  • Incarcerated ventral hernia requiring emergency surgery
  • Pregnancy
  • Patients with chronic pain due to arthritis, migraine or other illness requiring regular intake of analgesics (paracetamol, NSAID, opiates etc).
  • Current cancer diagnosis
  • History of psychiatric or addictive disorder that prevents the patient from participating in the trial
  • Co-existing inflammatory disease
  • Co-existing immunological disease that requires medication of any kind
  • BMI \>40 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sygehus Sønderjylland

Aabenraa, Southern Denmark, 6200, Denmark

Location

MeSH Terms

Conditions

Hernia, AbdominalHernia, UmbilicalHernia, Ventral

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Michael Festersen Nielsen

    Hospital of Southern Denmark - Aabenraa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 15, 2023

Study Start

May 15, 2023

Primary Completion

April 25, 2025

Study Completion

October 25, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)