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

NCT03770897 | Completed

• 1 other identifier: NVettoretto
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

3d Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Operative time.

  Time taken for the completion of the procedure

  1 minute after surgery

Secondary Outcomes (4)

• Conversion to open appendectomy.

  1 minute after surgery

• Intraoperative complication

  1 minute after surgery

• Post-operative complication. morbidity, readmission at 30th days, mortality

  30 days

• Surgeon's comfort

  1 hour after surgery

Study Arms (2)

3D laparoscopic appendectomy.

EXPERIMENTAL

Laparoscopic appendectomy will be performed with 3d technology device by young surgeons, tutored by an expert assistant.

Procedure: 3D Laparoscopic Appendectomy

2D laparoscopic appendectomy.

ACTIVE COMPARATOR

Laparoscopic appendectomy will be performed by young surgeons (tutored by an expert assistant) with the standard 2D viewing method.

Procedure: 2D Laparoscopic Appendectomy

Interventions

3D Laparoscopic Appendectomy PROCEDURE

surgical removal of inflamed cecal appendix by 3D laparoscopic procedure

3D laparoscopic appendectomy.

2D Laparoscopic Appendectomy PROCEDURE

surgical removal of inflamed cecal appendix by 2D laparoscopic procedure

2D laparoscopic appendectomy.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Presidio Ospedaliero di Montichiari, ASST degli Spedali Civili di Brescia

Montichiari, Brescia, 25018, Italy

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Surgery, Principal Investigator

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: December 10, 2018
• Study Start: September 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: May 31, 2019
• Last Updated: June 3, 2019

Record last verified: 2019-05

Locations

IT (1)