Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT05895058
Status:
UNKNOWN
Last Update Posted:
2023-08-16
First Post:
2023-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
2D 4K vs. 3D HD in Bariatric Laparoscopic Surgery
Sponsor:
Marko Kraljevic
Organization:
Study Overview
Official Title:
Comparison of 2D 4K vs. 3D HD Laparoscopic Imaging Systems in Bariatric Surgery: a Randomized Controlled Prospective Trial
Status:
UNKNOWN
Status Verified Date:
2023-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: