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

Appendicitis Clinical Trial

— LAPSUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770897
• Other study ID #: NVettoretto
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: May 2019
• Source: Azienda Ospedaliera Spedali Civili di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 31, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 3D Laparoscopic Appendectomy
surgical removal of inflamed cecal appendix by 3D laparoscopic procedure
• 2D Laparoscopic Appendectomy
surgical removal of inflamed cecal appendix by 2D laparoscopic procedure

Locations

Country	Name	City	State
Italy	Presidio Ospedaliero di Montichiari, ASST degli Spedali Civili di Brescia	Montichiari	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Spedali Civili di Brescia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time.	Time taken for the completion of the procedure	1 minute after surgery
Secondary	Conversion to open appendectomy.	Compare the rate of conversion between each arm.	1 minute after surgery
Secondary	Intraoperative complication	Accidental bowel or bladder perforation, uncontrolled bleeding.	1 minute after surgery
Secondary	Post-operative complication. morbidity, readmission at 30th days, mortality	Post-operative complication. morbidity, readmission at 30th days, mortality	30 days
Secondary	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