Appendicitis Clinical Trial
— LAPSUSOfficial title:
Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome. Randomized Multicenter Clinical Trial
Verified date | May 2019 |
Source | Azienda Ospedaliera Spedali Civili di Brescia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Presidio Ospedaliero di Montichiari, ASST degli Spedali Civili di Brescia | Montichiari | Brescia |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Spedali Civili di Brescia |
Italy,
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 |
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