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

NCT07275346 | Active Not Recruiting

• 1 other identifier: VH-OpenLapRob
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia

Keywords

laparoscopic surgery; robot-assisted surgery; ventral hernia; surgery

Outcome Measures

Primary Outcomes (1)

• % 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 Outcomes (4)

• Rate of.post operative complications

  1 month post surgery

• Recurrence

  2-7 years post surgery

• Length of stay

  Perioperatively

• Cost

  Up to 1 year post surgery

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Hernia operations combined with bowel procedures

Sponsors & Collaborators

• Andreas Älgå: lead
• Danderyds Hospital, Stockholm, Sweden: collaborator
• Sodertalje Hospital: collaborator
• Ersta Hospital, Sweden: collaborator
• Stockholm South General Hospital: collaborator

Study Sites (1)

Karolinska Institutet, Södersjukhuset

Stockholm, 11883, Sweden

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Älgå, MD, PhD

  Karolinsk Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 10, 2025
• Study Start: January 1, 2018
• Primary Completion: January 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-11

Locations

SE (1)