AppendicolithLAPSUSNCT03770897
Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome
A study testing 3D Laparoscopic Appendectomy and 2D Laparoscopic Appendectomy in people with Appendicolith and Appendicitis, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Appendicolith, Appendicitis, Appendicitis With Perforation
- What is being tested?
- 3D Laparoscopic Appendectomy and 2D Laparoscopic Appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2018to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All adult patients scheduled to undergo laparoscopic appendectomy. Ages eligible for study: >18 Sexes eligible for study: All
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Presidio Ospedaliero di Montichiari, ASST degli Spedali Civili di Brescia
Montichiari, Brescia, 25018
About this study
Official title: Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome. Randomized Multicenter Clinical Trial
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.
- Conditions
- Appendicolith, Appendicitis, Appendicitis With Perforation, Appendicitis Peritonitis, Appendiceal Abscess, Appendicitis Acute
- Being tested
- 3D Laparoscopic Appendectomy, 2D Laparoscopic Appendectomy
- Keywords
- 3d Laparoscopy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Laparoscopic AppendectomyProcedure or surgery
surgical removal of inflamed cecal appendix by 3D laparoscopic procedure
2D Laparoscopic AppendectomyProcedure or surgery
surgical removal of inflamed cecal appendix by 2D laparoscopic procedure
| Study group | Role | What they receive |
|---|---|---|
| 3D laparoscopic appendectomy. | Experimental | Laparoscopic appendectomy will be performed with 3d technology device by young surgeons, tutored by an expert assistant. Receives: Procedure: 3D Laparoscopic Appendectomy |
| 2D laparoscopic appendectomy. | Active comparator | Laparoscopic appendectomy will be performed by young surgeons (tutored by an expert assistant) with the standard 2D viewing method. Receives: Procedure: 2D Laparoscopic Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time.
Time taken for the completion of the procedure
Measured: 1 minute after surgery
Secondary outcomes (4)
Conversion to open appendectomy.
Compare the rate of conversion between each arm.
Measured: 1 minute after surgery
Intraoperative complication
Accidental bowel or bladder perforation, uncontrolled bleeding.
Measured: 1 minute after surgery
Post-operative complication. morbidity, readmission at 30th days, mortality
Post-operative complication. morbidity, readmission at 30th days, mortality
Measured: 30 days
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
Measured: 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start1 Sep 2018
- Primary completion30 Apr 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicolithStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nereo Vettoretto, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770897
- Sponsor's protocol ID
- NVettoretto
- Acronym
- LAPSUS
- Status last verified
- May 2019
- First submitted
- 28 Aug 2018
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome. Randomized Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT03770897
- Acronym / sponsor ID
- LAPSUS / NVettoretto
- Conditions
- Appendicolith, Appendicitis, Appendicitis With Perforation, Appendicitis Peritonitis, Appendiceal Abscess, Appendicitis Acute
- Keywords
- 3d Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D laparoscopic appendectomy. | Experimental | Procedure: 3D Laparoscopic AppendectomyLaparoscopic appendectomy will be performed with 3d technology device by young surgeons, tutored by an expert assistant. |
| 2D laparoscopic appendectomy. | Active comparator | Procedure: 2D Laparoscopic AppendectomyLaparoscopic appendectomy will be performed by young surgeons (tutored by an expert assistant) with the standard 2D viewing method. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients scheduled to undergo laparoscopic appendectomy. Ages eligible for study: >18 Sexes eligible for study: All
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Laparoscopic Appendectomysurgical removal of inflamed cecal appendix by 3D laparoscopic procedure | Procedure or surgery | 3D laparoscopic appendectomy. |
| 2D Laparoscopic Appendectomysurgical removal of inflamed cecal appendix by 2D laparoscopic procedure | Procedure or surgery | 2D laparoscopic appendectomy. |
Primary outcome
Operative time.
Time frame: 1 minute after surgery
Time taken for the completion of the procedure
4 secondary outcomes
Conversion to open appendectomy.
Time frame: 1 minute after surgery
Intraoperative complication
Time frame: 1 minute after surgery
Post-operative complication. morbidity, readmission at 30th days, mortality
Time frame: 30 days
Surgeon's comfort
Time frame: 1 hour after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Laparoscopic Appendectomy and 2D Laparoscopic Appendectomy in people with Appendicolith and Appendicitis, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time. (time frame: 1 minute after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.