Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome (LAPSUS)
Primary Purpose
Appendicolith, Appendicitis, Appendicitis With Perforation
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
3D Laparoscopic Appendectomy
2D Laparoscopic Appendectomy
Sponsored by
About this trial
This is an interventional treatment trial for Appendicolith focused on measuring 3d Laparoscopy
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
Sites / Locations
- Presidio Ospedaliero di Montichiari, ASST degli Spedali Civili di Brescia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
3D laparoscopic appendectomy.
2D laparoscopic appendectomy.
Arm Description
Laparoscopic appendectomy will be performed with 3d technology device by young surgeons, tutored by an expert assistant.
Laparoscopic appendectomy will be performed by young surgeons (tutored by an expert assistant) with the standard 2D viewing method.
Outcomes
Primary Outcome Measures
Operative time.
Time taken for the completion of the procedure
Secondary Outcome Measures
Conversion to open appendectomy.
Compare the rate of conversion between each arm.
Intraoperative complication
Accidental bowel or bladder perforation, uncontrolled bleeding.
Post-operative complication. morbidity, readmission at 30th days, mortality
Post-operative complication. morbidity, readmission at 30th days, mortality
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
Full Information
NCT ID
NCT03770897
First Posted
August 28, 2018
Last Updated
May 31, 2019
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
1. Study Identification
Unique Protocol Identification Number
NCT03770897
Brief Title
Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome
Acronym
LAPSUS
Official Title
Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome. Randomized Multicenter Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicolith, Appendicitis, Appendicitis With Perforation, Appendicitis Peritonitis, Appendiceal Abscess, Appendicitis Acute
Keywords
3d Laparoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3D laparoscopic appendectomy.
Arm Type
Experimental
Arm Description
Laparoscopic appendectomy will be performed with 3d technology device by young surgeons, tutored by an expert assistant.
Arm Title
2D laparoscopic appendectomy.
Arm Type
Active Comparator
Arm Description
Laparoscopic appendectomy will be performed by young surgeons (tutored by an expert assistant) with the standard 2D viewing method.
Intervention Type
Procedure
Intervention Name(s)
3D Laparoscopic Appendectomy
Intervention Description
surgical removal of inflamed cecal appendix by 3D laparoscopic procedure
Intervention Type
Procedure
Intervention Name(s)
2D Laparoscopic Appendectomy
Intervention Description
surgical removal of inflamed cecal appendix by 2D laparoscopic procedure
Primary Outcome Measure Information:
Title
Operative time.
Description
Time taken for the completion of the procedure
Time Frame
1 minute after surgery
Secondary Outcome Measure Information:
Title
Conversion to open appendectomy.
Description
Compare the rate of conversion between each arm.
Time Frame
1 minute after surgery
Title
Intraoperative complication
Description
Accidental bowel or bladder perforation, uncontrolled bleeding.
Time Frame
1 minute after surgery
Title
Post-operative complication. morbidity, readmission at 30th days, mortality
Description
Post-operative complication. morbidity, readmission at 30th days, mortality
Time Frame
30 days
Title
Surgeon's comfort
Description
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
Time Frame
1 hour after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Presidio Ospedaliero di Montichiari, ASST degli Spedali Civili di Brescia
City
Montichiari
State/Province
Brescia
ZIP/Postal Code
25018
Country
Italy
12. IPD Sharing Statement
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Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome
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