Surgical Approaches for Medium-to-Large Ventral Hernias: Open, Laparoscopic, and Robotic-Assisted Techniques

Evaluating Surgical Approaches for Medium-to-Large Ventral Hernias: Open, Laparoscopic, and Robotic-Assisted Techniques

The purpose of this project is to investigate whether the use of the new robot-assisted technique in surgery for large and medium-sized ventral midline hernias has brought tangible benefits to patients in terms of Textbook outcome, length of stay, complications and recurrence, compared to open technique and conventional laparoscopic technique. In addition, the investigators will assess the health economic aspects of the different techniques.

Study Overview

• Status: Active, not recruiting
• Conditions: Ventral Hernia

Detailed Description

In the Stockholm Region, ventral hernia surgeries are performed at Södersjukhuset, Danderyds Hospital, Södertälje Hospital, Norrtälje Hospital, St Göran Hospital, Ersta Hospital and Karolinska Hospital. The hospitals differ in terms of admission areas, profile areas and access to surgical robots for hernia surgery. Since the introduction of robot-assisted surgery in Stockholm around 2017-2018, Södersjukhuset and Danderyd Hospital have used this technology to varying extents for ventral hernia, while the other hospitals have only offered open and conventional laparoscopic surgery. There is no established distribution of hernia patients in the region and no joint treatment conferences. The patients have therefore been distributed primarily depending on place of residence and referral patterns between the hospitals, which has also influenced the choice of method. Similar hernia patients have thus been offered different surgical treatments depending on which hospital in Stockholm the patient was treated at.

The robotic platform involves significant investment costs and costs for robotic instruments. Several studies also indicate that the surgical time is often longer, which can also increase costs. However, the promising results with shorter hospital stay and fewer complications could outweigh the increased surgical costs that have been demonstrated in several studies. The investigators will compare the costs of robot-assisted ventral hernia surgery in the operating room, in the hospital and after discharge with the corresponding costs for open and conventional laparoscopic surgery. Cost-effectiveness analyses will be performed.

• Study Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11883
    • Karolinska Institutet, Södersjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients registered in the Swedish Abdominal Hernia Registry and operated on at Södersjukhuset, Ersta Hospital, Danderyd Hospital, or Södertälje Hospital

Description

Inclusion Criteria:

• Large and medium-sized midline hernias (EHS classification W2-W3)

Exclusion Criteria:

• Hernia operations combined with bowel procedures

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Open surgery; Patents who had open surgery for their ventral hernia
Conventional laparoscopic surgery; Patents who had conventional laparoscopic surgery for their ventral hernia
Robot-assisted laparoscopic surgery; Patents who had robot-assisted laparoscopic surgery for their ventral hernia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of patients with Textbook Outcome	Textbook Outcome is a composite outcome that will be used as a measure of a problem-free postoperative recovery. Textbook Oitcome will be defined as the absence of complications, prolonged hospital stay, readmission, and reoperation. Textbook Outcome is a binary outcome measure; the patient will either have Textbook Outcome (i.e. a problem-free postoperative recovery) or not (i.e. not a problem-free postoperative recovery).	1 month post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of.post operative complications	Post operative complications defined as Clavien-Dindo grade III or higher	1 month post surgery
Recurrence	A recurrence of the patients ventral hernia. Re-operation will be used as a proxy for recurrence.	2-7 years post surgery
Length of stay	Length of hospital stay for the surgery	Perioperatively
Cost	The costs of the three different surgical methods for ventral hernias. Cost-effectiveness calculations will be performed.	Up to 1 year post surgery

Collaborators and Investigators

• Sponsor: Andreas Älgå
• Collaborators: Stockholm South General Hospital; Sodertalje Hospital; Danderyds Hospital, Stockholm, Sweden; Ersta Hospital, Sweden
• Investigators: Principal Investigator: Andreas Älgå, MD, PhD, Karolinsk Institutet

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 31, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: surgery; laparoscopic surgery; ventral hernia; robot-assisted surgery
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Hernia, Ventral
• Other Study ID Numbers: VH-OpenLapRob

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No