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

Not Applicable

Completed

• Conditions: Appendicitis With Perforation; Appendicolith; Appendicitis Peritonitis; Appendiceal Abscess; Appendicitis; Appendicitis Acute
• Interventions: Procedure: 2D Laparoscopic Appendectomy; Procedure: 3D Laparoscopic Appendectomy

• Registration Number: NCT03770897
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-28
• Study Start: 2018-09-01
• Study First Submitted QC: 2018-12-07
• Study First Posted: 2018-12-10
• Primary Completion: 2019-04-30
• Status Verified: 2019-05
• Study Completion: 2019-05-31
• Last Update Submitted: 2019-05-31
• Last Update Posted: 2019-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2D laparoscopic appendectomy.	2D Laparoscopic Appendectomy	Laparoscopic appendectomy will be performed by young surgeons (tutored by an expert assistant) with the standard 2D viewing method.
3D laparoscopic appendectomy.	3D Laparoscopic Appendectomy	Laparoscopic appendectomy will be performed with 3d technology device by young surgeons, tutored by an expert assistant.

Primary Outcome Measures

Name	Time	Method
Operative time.	1 minute after surgery	Time taken for the completion of the procedure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Presidio Ospedaliero di Montichiari, ASST degli Spedali Civili di Brescia; 🇮🇹 Montichiari, Brescia, Italy