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Search / Trial NCT05895058

2D 4K vs. 3D HD in Bariatric Laparoscopic Surgery

Launched by MARKO KRALJEVIC · May 30, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Laparoscopy 2 D 4 K Vision System 3 D Hd Vision System Bariatric Surgery

ClinConnect Summary

This clinical trial is comparing two different imaging systems used during a specific type of weight loss surgery called gastric bypass. The two systems being studied are a two-dimensional (2D) ultra-high-resolution (4K) monitor and a three-dimensional (3D) high-definition (HD) system. Researchers want to find out if the 3D HD system helps surgeons work faster and with fewer complications compared to the 2D 4K system. The study aims to learn about not just the operation time, but also how the surgery affects the patient’s recovery and hospital stay.

To participate in this trial, you need to be an adult over 18 years old with a body mass index (BMI) over 35 and a history of unsuccessful weight loss through diet alone for at least two years. However, certain health conditions, such as severe obesity (BMI over 50), active cancer, or serious liver disease, may prevent you from joining. If you choose to participate, you'll be asked to sign a consent form, which means you understand the study and agree to take part. Overall, this trial aims to improve surgical outcomes and patient recovery times in bariatric surgery.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients with the indication for gastric bypass according to SMOB guidelines: BMI \> 35, Age \> 18 and Cumulative two years of controlled conservative dieting without weight loss
  • Informed Consent signed by the patient
  • Exclusion Criteria:
  • Patients who do not have an indication for gastric bypass due to one or more of the criteria listed here: BMI \> 50, Lack of adequate weight loss therapy for two years, Malignant disease, Liver cirrhosis Child A, Morbus Crohn, Carcinoma patients, Serious mental illness requiring treatment (not attributable to obesity), Chronic abuse of drugs, Lack of compliance (missed appointments, inability to cooperate), Lack of understanding of the requirements and conditions of postoperative therapy and treatment (confirmed by the specialist)
  • Patient does not sign Informed Consent

About Marko Kraljevic

Marko Kraljevic is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative trial design and execution. With a strong focus on ethical standards and regulatory compliance, Marko Kraljevic collaborates with leading healthcare professionals and research institutions to ensure the integrity and reliability of clinical data. By prioritizing patient safety and leveraging cutting-edge methodologies, the organization aims to expedite the development of new therapeutics while fostering a culture of transparency and collaboration within the clinical research community.

Locations

Basel, , Switzerland

Patients applied

0 patients applied

Trial Officials

Marko Kraljevic, PD Dr. med.

Principal Investigator

Clarunis - Universitäres Bauchzentrum Basel

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported