Administrative information
Title {1} | Comparison of 2D 4K vs. 3D HD laparoscopic imaging systems in bariatric surgery: study protocol for a randomized controlled prospective trial |
Trial registration {2a and 2b}. | This trial is registered at clinicaltrials.gov under the identifier NCT05895058. Registered 30 May 2023. BASEC2023-D0014 [Registry ID Swissethics] SNCTP000005489 [SNCTP study register] |
Protocol version {3} | Version 2.0 of date 08/04/2023 |
Funding {4} | Internal funding/In-house resources. All data were collected as part of routine treatment or follow-up of a gastric bypass operation. The medical devices (MD) are provided by the University Hospital Basel. |
Author details {5a} | Dr. med. Tibor Andrea Zwimpfer Department of Obstetrics and Gynecology Department of Biomedicine University Hospital Basel Spitalstrasse 21 4056 Basel, Switzerland tiborandrea.zwimpfer@usb.ch Nadja Stiegeler Medical Faculty University of Basel Klingelbergstrasse 61 4056 Basel, Switzerland nadja@stiegeler.ch PD Dr. med. Philip C. Müller Department of Visceral Surgery Clarunis - University Center for Gastrointestinal and Liver Diseases, St. Clara Hospital and University Hospital Basel 4002 Basel, Switzerland philip.mueller@clarunis.ch Andreas Schötzau Department of Obstetrics and Gynecology University Hospital Basel Spitalstrasse 21 4056 Basel, Switzerland andreas.schoetzau@usb.ch Dr. med. Bernhard Fellmann-Fischer Department of Obstetrics and Gynecology University Hospital Basel Spitalstrasse 21 4056 Basel, Switzerland bernhard.fellmann@usb.ch Prof. Dr. med. Viola Heinzelmann-Schwarz Department of Obstetrics and Gynecology Department of Biomedicine University Hospital Basel Spitalstrasse 21 4056 Basel, Switzerland viola.heinzelmann@usb.ch Prof. Dr. med. Ralph Peterli Department of Visceral Surgery Clarunis - University Center for Gastrointestinal and Liver Diseases, St. Clara Hospital and University Hospital Basel 4002 Basel, Switzerland ralph.peterli@clarunis.ch PD Dr. med. Marko Kraljević Department of Visceral Surgery Clarunis - University Center for Gastrointestinal and Liver Diseases, St. Clara Hospital and University Hospital Basel 4002 Basel, Switzerland marko.kraljevic@clarunis.ch |
Name and contact information for the trial sponsor {5b} | PD Dr. med. Marko Kraljević Department of Visceral Surgery Clarunis – University Center for Gastrointestinal and Liver Diseases, St. Clara Hospital and University Hospital Basel 4002 Basel, Switzerland + 41 61,777 73 15 marko.kraljevic@clarunis.ch |
Role of sponsor {5c} | Marko Kraljević is the Sponsor-Investigator and one of the operating surgeons in the study. Together with his surgical team, he will recruit patients, inform them about the study and obtain informed consent. He will be responsible for performing the surgeries and collecting the data. After surgery, he will provide the data to the other authors of the study for further processing, analysis, and interpretation, and will write the report. He has final authority over all activities. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Inclusion criteria
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Patients with an indication for gastric bypass according to the Swiss Morbid Obesity Group (SMOB) guidelines: age ≥ 18 years, BMI ≥ 35, and a cumulative 2 years of controlled conservative diet without weight loss
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Signed informed consent
Exclusion criteria
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Patients who are ineligible for gastric bypass based on one or more of the following criteria: BMI ≥ 50, lack of adequate weight loss therapy for 2 years, malignant disease, Child A cirrhosis, Crohn’s disease, carcinoma patients, severe mental illness requiring treatment (not due to obesity that has led to more than one inpatient psychiatric hospitalization in the last 2 years), chronic substance abuse, 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)
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Non-signed informed consent
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparator {6b}
Intervention description {11a}
Surgery procedure
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Primary
Secondary
Participant timeline {13}
Sample size {14}
Recruitment {15}
Assignment of interventions: allocation
Sequence generation {16a}
Concealment mechanism {16b}
Implementation {16c}
Assignment of interventions: blinding
Who will be blinded {17a}
Procedure for unblinding if needed {17b}
Data collection and management
Plans for assessment and collection of outcomes {18a}
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Mental demands: How mentally fatiguing was the procedure?
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Physical demands: How physically fatiguing was the procedure?
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Temporal demands: How hurried or rushed was the pace of the procedure?
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Task complexity: How complex was the procedure?
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Situational stress: How anxious did you feel while performing the procedure?
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Distractions: How distracting was the operating environment?
Plans to promote participant retention and complete follow-up {18b}
Data management {19}
Confidentiality {27}
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
Statistical methods
Statistical methods for primary and secondary outcomes {20a}
Interim analyses {21b}
Methods for additional analyses (e.g., subgroup analyses) {20b}
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
Plans to give access to the full protocol, participant-level data, and statistical code {31c}
Oversight and monitoring
Composition of the coordinating center and trial steering committee {5d}
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Sponsor-investigator: takes over the supervision of the study and the medical responsibility for the patients, in addition he is one of the three defined operators of the study
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Medical expert: advises, conducted the corresponding preclinical study comparing 2D 4K vs. 3D HD on a pelvitrainer model [8]
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Study coordinator: enrollment, coordination of study visits, annual safety reports
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Statistician: organizes data collection, ensures quality, and analyzes data
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Other investigators/operators: recruit, obtain consent, operate, and ensure follow-up according to protocol