Clinical trial NCT05895058: 2D 4K vs. 3D HD in Bariatric Laparoscopic Surgery
Official title: Comparison of 2D 4K vs. 3D HD Laparoscopic Imaging Systems in Bariatric Surgery: a Randomized Controlled Prospective Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopy
Keywords: Laparoscopy
2D 4K vision system
3D HD vision system
Bariatric Surgery
Lead sponsor: Clarunis - Universitäres Bauchzentrum Basel
Sponsor class: OTHER
Collaborators: name: University Hospital, Basel, Switzerland
First posted: 2023-06-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Operation time
timeFrame: intraoperative
Secondary outcomes:
measure: Intraoperative Complications
timeFrame: Immediately after surgery up to one day postoperatively
measure: Workload of the operating surgeon
timeFrame: Immediately after surgery
measure: Postoperative Complications
timeFrame: Follow-up until the first postoperative Check-up after three months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clarunis University Center for Gastrointestinal and Liver Diseases
Study officials:
affiliation: Clarunis - Universitäres Bauchzentrum Basel
name: Marko Kraljevic, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: