Clinical trial NCT03770897: Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome
Official title: Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome. Randomized Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicolith
Appendicitis
Appendicitis With Perforation
Appendicitis Peritonitis
Appendiceal Abscess
Appendicitis Acute
Keywords: 3d Laparoscopy
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 128
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Operative time.
timeFrame: 1 minute after surgery
Secondary outcomes:
measure: Conversion to open appendectomy.
timeFrame: 1 minute after surgery
measure: Intraoperative complication
timeFrame: 1 minute after surgery
measure: Post-operative complication. morbidity, readmission at 30th days, mortality
timeFrame: 30 days
measure: Surgeon's comfort
timeFrame: 1 hour after surgery
Other outcomes:
Locations:
city: Montichiari
country: Italy
facility: Presidio Ospedaliero di Montichiari, ASST degli Spedali Civili di Brescia
state: Brescia
Study officials:
References: