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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Procedure: 3D Laparoscopic Appendectomy
* Procedure: 2D Laparoscopic Appendectomy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D laparoscopic appendectomy.<br>Laparoscopic appendectomy will be performed with 3d technology device by young surgeons, tutored by an expert assistant. | Procedure: 3D Laparoscopic Appendectomy<br>* surgical removal of inflamed cecal appendix by 3D laparoscopic procedure<br>|
| Active Comparator: 2D laparoscopic appendectomy.<br>Laparoscopic appendectomy will be performed by young surgeons (tutored by an expert assistant) with the standard 2D viewing method. | Procedure: 2D Laparoscopic Appendectomy<br>* surgical removal of inflamed cecal appendix by 2D laparoscopic procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time. | Time taken for the completion of the procedure | 1 minute after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion to open appendectomy. | Compare the rate of conversion between each arm. | 1 minute after surgery | 
| Intraoperative complication | Accidental bowel or bladder perforation, uncontrolled bleeding. | 1 minute after surgery | 
| Post-operative complication. morbidity, readmission at 30th days, mortality | Post-operative complication. morbidity, readmission at 30th days, mortality | 30 days | 
| Surgeon's comfort | 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 | 1 hour after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3d Laparoscopy