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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Appendicolith Appendicitis Appendicitis With Perforation Appendicitis Peritonitis Appendiceal Abscess Appendicitis Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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3D laparoscopic appendectomy.

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

Group Type EXPERIMENTAL

3D Laparoscopic Appendectomy

Intervention Type PROCEDURE

surgical removal of inflamed cecal appendix by 3D laparoscopic procedure

2D laparoscopic appendectomy.

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

Group Type ACTIVE_COMPARATOR

2D Laparoscopic Appendectomy

Intervention Type PROCEDURE

surgical removal of inflamed cecal appendix by 2D laparoscopic procedure

Interventions

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3D Laparoscopic Appendectomy

surgical removal of inflamed cecal appendix by 3D laparoscopic procedure

Intervention Type PROCEDURE

2D Laparoscopic Appendectomy

surgical removal of inflamed cecal appendix by 2D laparoscopic procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No