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Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome

Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome. Randomized Multicenter Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03770897
Acronym
LAPSUS
Enrollment
128
Registered
2018-12-10
Start date
2018-09-01
Completion date
2019-05-31
Last updated
2019-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendiceal Abscess, Appendicitis, Appendicitis Acute, Appendicitis Peritonitis, Appendicitis With Perforation, Appendicolith

Keywords

3d Laparoscopy

Brief summary

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.

Interventions

PROCEDURE3D Laparoscopic Appendectomy

surgical removal of inflamed cecal appendix by 3D laparoscopic procedure

PROCEDURE2D Laparoscopic Appendectomy

surgical removal of inflamed cecal appendix by 2D laparoscopic procedure

Sponsors

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All adult patients scheduled to undergo laparoscopic appendectomy. Ages eligible for study: \>18 Sexes eligible for study: All

Exclusion criteria

* Patients who decline to join the study * Patients under 18 years old * Patients with contraindication to undergo laparoscopic surgery. * Patients without appendicular disease found at laparoscopy (such as complicated inflammatory bowel disease, tumor, complicated diverticula, gynecological disorder) * Patients undergoing open appendectomy

Design outcomes

Primary

MeasureTime frameDescription
Operative time.1 minute after surgeryTime taken for the completion of the procedure

Secondary

MeasureTime frameDescription
Conversion to open appendectomy.1 minute after surgeryCompare the rate of conversion between each arm.
Intraoperative complication1 minute after surgeryAccidental bowel or bladder perforation, uncontrolled bleeding.
Post-operative complication. morbidity, readmission at 30th days, mortality30 daysPost-operative complication. morbidity, readmission at 30th days, mortality
Surgeon's comfort1 hour after surgerybased 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026