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Completed

NCT Number: NCT03770897

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

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Presidio Ospedaliero di Montichiari, ASST degli Spedali Civili di Brescia

Montichiari, Brescia, 25018, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D Laparoscopic Appendectomy

Procedure

surgical removal of inflamed cecal appendix by 3D laparoscopic procedure

2D Laparoscopic Appendectomy

Procedure

surgical removal of inflamed cecal appendix by 2D laparoscopic procedure

Primary outcomes

  1. Operative time.

    Time frame: 1 minute after surgery

    Time taken for the completion of the procedure

Secondary outcomes

  1. Conversion to open appendectomy.

    Time frame: 1 minute after surgery

    Compare the rate of conversion between each arm.

  2. Intraoperative complication

    Time frame: 1 minute after surgery

    Accidental bowel or bladder perforation, uncontrolled bleeding.

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

    Time frame: 30 days

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

  4. Surgeon's comfort

    Time frame: 1 hour after surgery

    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

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Registry information

Official study title

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

Acronym: LAPSUS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2018
Registry last updated
Jun 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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