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

NCT05895058 | Unknown DMC

• 1 other identifier: 3D4K
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopy

Keywords

Laparoscopy; 2D 4K vision system; 3D HD vision system; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• Operation time

  Operation time (OT) is defined from the beginning of the operation by incision of the skin to the end of the operation by the end of the skin suture.

  intraoperative

Secondary Outcomes (3)

• Intraoperative Complications

  Immediately after surgery up to one day postoperatively

• Workload of the operating surgeon

  Immediately after surgery

• Postoperative Complications

  Follow-up until the first postoperative Check-up after three months

Study Arms (2)

2D 4K laparoscopic imaging system

EXPERIMENTAL

Performing gastric bypass surgery intervention using a 2D 4K laparoscopic imaging system.

Device: Gastric bypass surgery with 2D 4K laparoscopic imaging

3D HD laparoscopic imaging system

ACTIVE COMPARATOR

Performing gastric bypass surgery intervention using a 3D HD laparoscopic imaging system.

Device: Gastric bypass surgery with 3D HD laparoscopic imaging

Interventions

Gastric bypass surgery with 2D 4K laparoscopic imaging DEVICE

All patients involved in the investigation will receive a laparoscopic Roux-en-Y gastric bypass (LRYGB). The interventions are performed by three defined surgeons.

2D 4K laparoscopic imaging system

Gastric bypass surgery with 3D HD laparoscopic imaging DEVICE

All patients involved in the investigation will receive a laparoscopic Roux-en-Y gastric bypass (LRYGB). The interventions are performed by three defined surgeons.

3D HD laparoscopic imaging system

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marko Kraljevic: lead
• University Hospital, Basel, Switzerland: collaborator

Study Sites (1)

Clarunis University Center for Gastrointestinal and Liver Diseases

Basel, Switzerland

RECRUITING

Related Publications (1)

• Zwimpfer TA, Stiegeler N, Muller PC, Schotzau A, Fellmann-Fischer B, Heinzelmann-Schwarz V, Peterli R, Kraljevic M. Comparison of 2D 4K vs. 3D HD laparoscopic imaging systems in bariatric surgery: study protocol for a randomized controlled prospective trial. Trials. 2024 Feb 22;25(1):140. doi: 10.1186/s13063-024-07983-4.

  PMID: 38389113 DERIVED

Study Officials

• Marko Kraljevic, PD Dr. med.

  Clarunis - Universitäres Bauchzentrum Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tibor Andrea Zwimpfer, Dr. med.

CONTACT

079 901 79 66; tibor.zwimpfer@unibas.ch

Stiegeler Nadja

CONTACT

079 901 79 66; nadja@stiegeler.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: June 8, 2023
• Study Start: August 10, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 16, 2023

Record last verified: 2023-08

Locations

CH (1)