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Clinical Trials/NCT03770897
NCT03770897CompletedNot Applicable

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

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia1 site in 1 country128 target enrollmentStarted: September 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
128
Locations
1
Primary Endpoint
Operative time.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

3D laparoscopic appendectomy.

Experimental

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

Intervention: 3D Laparoscopic Appendectomy (Procedure)

2D laparoscopic appendectomy.

Active Comparator

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

Intervention: 2D Laparoscopic Appendectomy (Procedure)

Outcomes

Primary Outcomes

Operative time.

Time Frame: 1 minute after surgery

Time taken for the completion of the procedure

Secondary Outcomes

  • Conversion to open appendectomy.(1 minute after surgery)
  • Intraoperative complication(1 minute after surgery)
  • Surgeon's comfort(1 hour after surgery)
  • Post-operative complication. morbidity, readmission at 30th days, mortality(30 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nereo Vettoretto

Head of Surgery, Principal Investigator

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Study Sites (1)

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