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

NCT ID: NCT05895058

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2025-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

2D 4K laparoscopic imaging system

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

Group Type: EXPERIMENTAL

Gastric bypass surgery with 2D 4K laparoscopic imaging

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Gastric bypass surgery with 3D HD laparoscopic imaging

Intervention Type: 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.

Interventions

Gastric bypass surgery with 2D 4K laparoscopic imaging

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

Intervention Type: DEVICE

Gastric bypass surgery with 3D HD laparoscopic imaging

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: collaborator

Marko Kraljevic

OTHER

Sponsor Role: lead

Responsible Party

Marko Kraljevic

PD Dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marko Kraljevic, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Clarunis - Universitäres Bauchzentrum Basel

Locations

Clarunis University Center for Gastrointestinal and Liver Diseases

Basel, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Tibor Andrea Zwimpfer, Dr. med.

Role: CONTACT

tibor.zwimpfer@unibas.ch

079 901 79 66 ext. +41

Stiegeler Nadja

Role: CONTACT

nadja@stiegeler.ch

079 901 79 66 ext. +41

Facility Contacts

Ralph Peterli, Prof. Dr.

Role: primary

ralph.peterli@clarunis.ch

References

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.

Reference Type: DERIVED

PMID: 38389113 (View on PubMed)

Other Identifiers

3D4K

Identifier Type: -

Identifier Source: org_study_id