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

Last updated: August 15, 2023
Sponsor: Marko Kraljevic
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Gastric bypass surgery with 3D HD laparoscopic imaging

Gastric bypass surgery with 2D 4K laparoscopic imaging

Clinical Study ID

NCT05895058
3D4K
  • Ages > 18
  • All Genders

Study Summary

Laparoscopy has become an indispensable part of modern surgery. Vision is an important and defining element of laparoscopy and significantly affects the outcome of an operation in regard to time, mistakes and precision. Several new imaging systems have become available for laparoscopic surgery, including three-dimensional (3D) high-definition (HD), and two-dimensional (2D) ultra-high-resolution (4K) monitors. In experimental and clinical settings, several studies have been published in recent years suggesting that 3D systems present a number of potential benefits for surgeons and patients compared to the conventional 2D systems. The 3D HD system significantly reduces operation time and blood loss, and additionally shortens hospital stay. However, the performance of 3D systems against the new, ultra-high-definition 4K systems is barely known and highly controversial. There is a paucity of studies comparing these two imaging systems in clinical settings. The goal of this clinical trial is to compare 2D 4K versus 3D HD imaging systems in a complex bariatric surgery, more precisely a gastric bypass operation. The investigators aim to investigate the hypothesis stating that the use of the 3D HD system yields a significant improvement in operating time compared to a 2D 4K system in bariatric laparoscopic surgery. Furthermore, in order to give a comprehensive overview of the comparison of 2D 4K and 3D HD laparoscopy in a clinical setting, the investigators will assess the workload of the surgeon as well as the intraoperative and postoperative complications including the hospitalization time.

Eligibility Criteria

Inclusion

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 withoutweight loss
  • Informed Consent signed by the patient

Exclusion

Exclusion Criteria:

  • Patients who do not have an indication for gastric bypass due to one or more of thecriteria listed here: BMI > 50, Lack of adequate weight loss therapy for two years,Malignant disease, Liver cirrhosis Child A, Morbus Crohn, Carcinoma patients, Seriousmental illness requiring treatment (not attributable to obesity), Chronic abuse ofdrugs, Lack of compliance (missed appointments, inability to cooperate), Lack ofunderstanding of the requirements and conditions of postoperative therapy andtreatment (confirmed by the specialist)
  • Patient does not sign Informed Consent

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Gastric bypass surgery with 3D HD laparoscopic imaging
Phase:
Study Start date:
August 10, 2023
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Clarunis University Center for Gastrointestinal and Liver Diseases

    Basel,
    Switzerland

    Active - Recruiting

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