Open Versus Robotic-assisted Ventral Hernia Repair, Short and Long-term Outcome

NCT ID: NCT05906017

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2025-10-25

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.

Detailed Description

Ventral hernias occur in up to 25% of the population. They are diverse in severity ranging from small umbilical hernias to large abdominal wall defects that may result in loss of domain. Approximately one-third are incisional hernias. Incisional hernias are usually more complex due to complications from previous surgery. The procedure may be complicated as a result of intraabdominal bowel adhesions and adhesions within the hernial sac. These factors cause discomfort and may complicate the repair. Ventral hernias may be repaired either through a minimally invasive laparoscopic procedure or an open approach. The laparoscopic repair was introduced in the 1990s and in 2003 the first robotic-assisted procedure was described in a porcine model. In 2012 the first series of robotic repairs were reported in humans. Due to the superior flexibility of the robotic instruments, there is a substantial interest in harnessing the advantages of the robotic platform. Because robotic repair differs in several technical aspects from the open approach, it is important to determine whether the short and long-term results differ between the two procedures. Furthermore, it remains unresolved whether the robotic procedure is able to provide comparable outcomes to the open repair when assessed for quality-of-life outcome measures. These questions are important to address in order to determine the most appropriate surgical options for individual patients.

Conditions

Abdominal Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open repair

Open ventral hernia repair

Group Type: ACTIVE_COMPARATOR

Open Hernia surgery

Intervention Type: PROCEDURE

midline ventral hernia repair - open

Robotic-assisted repair

Robotic-assisted ventral hernia repair

Group Type: EXPERIMENTAL

Robotic Hernia surgery

Intervention Type: PROCEDURE

midline ventral hernia repair - robotic

Interventions

Open Hernia surgery

midline ventral hernia repair - open

Intervention Type: PROCEDURE

Robotic Hernia surgery

midline ventral hernia repair - robotic

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Festersen Nielsen

Role: STUDY_DIRECTOR

Hospital of Southern Denmark - Aabenraa

Locations

Sygehus Sønderjylland

Aabenraa, Southern Denmark, Denmark

Countries

Denmark

Other Identifiers

SHS-MT Kir-2-2023

Identifier Type: -

Identifier Source: org_study_id