Presidio Ospedaliero di Montichiari, ASST degli Spedali Civili di Brescia
Montichiari, Brescia, 25018, Italy
NCT Number: NCT03770897
Laparoscopy has revolutionized the approach to a number of surgical problems causing a re-evaluation of several clinical strategies. Now it has become the standard treatment for majority of ailments including symptomatic gall stone disease, appendicitis, GERD (gastroesophageal reflux disease), morbid obesity and colorectal disease. All these developments aim at minimizing perioperative morbidities, providing rapid postoperative recovery and enhancing patient's safety profile. One of the major limitations of conventional laparoscopy is lack of depth perception. Introduction of 3D imaging, has removed many of these technical obstacles. In 1993, Becker et al., reported that a 3D display might improve laparoscopic skills. Since then, many researchers have demonstrated benefit of 3D imaging . Starting from this, we can theorize an impact of 3D technologies on surgeon's learning curves. This concern is recently being demonstrated in experimental and clinical setting with improvement of hand-eye coordination, better laparoscopic skills and less time to learn surgical procedure. Usually junior surgeons (JS) start their activities with cholecystectomy and appendectomy but, despite an amount of literature regarding the first procedure, there is a 'black hole' regarding the use of 3D imaging in laparoscopic appendectomy (LA).
The investigators decided to investigate the impact of 3D visualization on surgeons' and surgical outcome during laparoscopic appendectomy (LA) performed by junior surgeons (JS). Operative details and clinical aspect are both take in account in order to looking for any advantages or concerns conferred on JS in performing LA.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Montichiari, Brescia, 25018, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
surgical removal of inflamed cecal appendix by 3D laparoscopic procedure
surgical removal of inflamed cecal appendix by 2D laparoscopic procedure
Time frame: 1 minute after surgery
Time taken for the completion of the procedure
Time frame: 1 minute after surgery
Compare the rate of conversion between each arm.
Time frame: 1 minute after surgery
Accidental bowel or bladder perforation, uncontrolled bleeding.
Time frame: 30 days
Post-operative complication. morbidity, readmission at 30th days, mortality
Time frame: 1 hour after surgery
based on questionnaire following the operation: LIKERT scale: from 1 to 5 points for 8 items divided in 2 evaluation: surgical outcome and surgical strain.
Surgical outcome:
item 1: surgical skill perception item 2: definition of surgical field item 3: deep perception
Surgical strain:
item1: hand and wrist strain item 2: neck strain item 3: back strain item 4: eye strain item 5: performance anxiety
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Other
Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome. Randomized Multicenter Clinical Trial
Acronym: LAPSUS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06296953
Abdomen, Acute, Abdominal Pain
Halmstad, Sweden
View Trial DetailsNCT04614649
Abdominal Pain, Appendicitis
Ankara, Turkey (Türkiye)
View Trial DetailsNCT05401188
Appendicitis, Appendicitis Acute
Tarragona, Spain
View Trial DetailsNCT05315869
Appendicitis, Appendicitis Acute
Prague, Czechia
View Trial Details