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

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

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.

Study Overview

• Status: Completed
• Conditions: Appendicitis; Appendicitis Acute; Appendiceal Abscess; Appendicolith; Appendicitis With Perforation; Appendicitis Peritonitis
• Intervention / Treatment: Procedure: 3D Laparoscopic Appendectomy; Procedure: 2D Laparoscopic Appendectomy

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Brescia
    • Montichiari, Brescia, Italy, 25018
      • Presidio Ospedaliero di Montichiari, ASST degli Spedali Civili di Brescia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): June 3, 2019
• Last Update Submitted That Met QC Criteria: May 31, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: 3d Laparoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis; Peritonitis
• Other Study ID Numbers: NVettoretto

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No