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

NCT ID: NCT07275346

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 750 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

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.

Conditions

Ventral Hernia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Open surgery

Patents who had open surgery for their ventral hernia

No interventions assigned to this group

Conventional laparoscopic surgery

Patents who had conventional laparoscopic surgery for their ventral hernia

No interventions assigned to this group

Robot-assisted laparoscopic surgery

Patents who had robot-assisted laparoscopic surgery for their ventral hernia

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Hernia operations combined with bowel procedures

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

Sponsors

Danderyds Hospital, Stockholm, Sweden

UNKNOWN

Sponsor Role: collaborator

Sodertalje Hospital

OTHER

Sponsor Role: collaborator

Ersta Hospital, Sweden

OTHER

Sponsor Role: collaborator

Stockholm South General Hospital

OTHER

Sponsor Role: collaborator

Andreas Älgå

OTHER

Sponsor Role: lead

Responsible Party

Andreas Älgå

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andreas Älgå, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinsk Institutet

Locations

Karolinska Institutet, Södersjukhuset

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

VH-OpenLapRob

Identifier Type: -

Identifier Source: org_study_id