Complication Laparoscopic CholecystectomyNCT03143426
Does 3D Visualisation Improve Performance of Laparoscopic Cholecystectomy by Junior Surgeons?
A study testing 3D laparoscopic cholecystectomy in people with Complication Laparoscopic Cholecystectomy and Conversion Laparoscopic to Open Cholecystectomy, run by Clinical Research Centre, Malaysia at 1 site in Malaysia.
Trial summary
Laparoscopic cholecystectomy (LC) is currently the most commonly performed major abdominal surgery in Western countries. Ever since the introduction of laparoscopic surgery in the late 1980s, cholecystectomies are now routinely performed laparoscopically; concomitantly the introduction and refinement of other… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication Laparoscopic Cholecystectomy, Conversion Laparoscopic to Open Cholecystectomy
- What is being tested?
- 3D laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Apr 2017to 30 Sep 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients scheduled to undergo elective LC
Who cannot join
- Patients below 18 years-old
- Patients who declined to join the study
- Patients with contraindications to undergo laparoscopic surgery (e.g. congestive cardiac failure, severe respiratory disease, uncorrected coagulopathy)
- Patients with acute cholecystitis, gallbladder neck adherent to main biliary tree or dense omental adhesion to gallbladder
- Patients with gallbladder tumour (suspected or confirmed)
- Patients with variant biliary anatomy
- Patients who had defaulted follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does 3D Visualisation Improve Performance of Laparoscopic Cholecystectomy by Junior Surgeons? A Randomised Controlled Trial
Laparoscopic cholecystectomy (LC) is currently the most commonly performed major abdominal surgery in Western countries. Ever since the introduction of laparoscopic surgery in the late 1980s, cholecystectomies are now routinely performed laparoscopically; concomitantly the introduction and refinement of other laparoscopic abdominal surgeries have rapidly progressed due to the early experience and safety profile seen in LC.
The introduction of stereoscopes which allow for 3D visual feedback has been postulated to overcome setbacks encountered in conventional 2-dimensional (2D) laparoscopic surgery. Since its introduction in the mid-2000s, 3D visualisation has been proven to be advantageous over 2D visualisation, especially so within the context of training junior surgeons in controlled, experimental settings. The body of evidence on benefits of 3D visualisation within the clinical setting, i.e. when applied on live patients in operating theatres, remains small and weak. The previous publications however did not extrapolate any potential benefits on patients' well-being in correlation to their reported benefits and neither did they explore any potential benefits in reducing operative complications.
We decided to embark on a study to investigate any peri-operative advantage conferred on junior surgeons in performing LC using 3D visualisation as the majority of LCs in Sibu Hospital are carried out by junior surgeons.
Read the detailed description
Laparoscopic cholecystectomy (LC) is currently the most commonly performed major abdominal surgery in Western countries.1,2 Ever since the introduction of laparoscopic surgery in the late 1980s, cholecystectomies are now routinely performed laparoscopically; concomitantly the introduction and refinement of other laparoscopic abdominal surgeries have rapidly progressed due to the early experience and safety profile seen in LC.
Although the benefits of LC are well described (e.g. decreased post-operative pain, decreased need for post-operative analgesia, shortened hospital stay and earlier return to full activity),3,4 it is not completely risk-free. The surgeon's experience, or rather the lack of, has been previously identified as one of the significant correlations to inadvertent visceral injury.5 According to the European Association for Endoscopic Surgery, a minimum of 20 LCs are necessary before a surgeon is deemed able to perform it safely.6 This is consistent with the concept of the learning curve as analysed by Moore and Bennett; they noted that 90% of iatrogenic bile duct injuries occurred within the first 30 cases of the operating surgeon's experience.7 Publications on LC learning curve have identified the risk of an iatrogenic bile duct injury as 0.17% - 0.35% after a surgeon's 50th case as opposed to 1.3 - 1.7% when fewer than 50 cases.7,8 These higher risks of iatrogenic injuries have been attributed to the major setbacks encountered during conventional laparoscopic surgery, chiefly the lack of depth perception and tactile sensory feedback to the operating surgeon thus risking inadvertent injury to surrounding structures and imprecise dissection within the Calot's triangle. While the importance of senior supervision and guidance are indispensible, the technical short-comings of conventional laparoscopic surgery, i.e. the lack of depth perception, have led to the development of technology to allow for 3-dimensional (3D) visualisation.
The introduction of stereoscopes which allow for 3D visual feedback has been postulated to overcome these setbacks encountered in conventional 2-dimensional (2D) laparoscopic surgery. Since its introduction in the mid-2000s, 3D visualisation has been proven to be advantageous over 2D visualisation, especially so within the context of training junior surgeons in controlled, experimental settings.9,10 The body of evidence on benefits of 3D visualisation within the clinical setting, i.e. when applied on live patients in operating theatres, remains small and weak. These were mostly small, single-institution studies focused only on specific laparoscopic procedures such as hernia repair, distal gastrectomies,11 urologic12,13,14 and gynaecologic15,16 procedures.
Sakata and workers also believed that advantages conferred by 3D visualisation has been underreported and undermined by flawed study designs and utilised mostly earlier generation of 3D stereoscopes that has since been phased out, therefore undermining the clinical potential of 3D laparoscopy.17 Experience with utilisation of 3D visualisation in performing LC is still in its infancy and to the authors' knowledge, there have been no unfavourable results reported with the use of 3D visualisation for laparoscopic surgery. Data on direct comparison of 2D against 3D LC is still scarce; there are only three such studies and all demonstrated superiority of 3D over 2D visualisation in LC. These studies, though originating from tertiary institutions, are hampered by the limited numbers of patients operated using 3D visualisation (n = 8, 15 \& 40 respectively).11,18,19 The third study,19 reported advantages of 3D visualisation conferred to junior surgeons in terms of reducing operative time, better depth perception and reduced subjective visual strain. The authors however did not extrapolate any potential benefits on patients' well-being in correlation to their reported benefits and neither did they explore any potential benefits in reducing operative complications.
Sibu Hospital is a 534-bedded tertiary and referral hospital for advanced specialised health care within the central region of Sarawak. Data from 2007 estimated that Sibu Hospital serves a population of at least 500 000 and this population is believed to have doubled to date.20 The department of general surgery is headed by a senior consultant surgeon (AD) and this department also serves as a training center for junior surgeons who have just completed their post-graduate qualifications. Under the tutelage of at least one senior consultant general surgeon, these junior surgeons are mentored through their early learning curves in performing major complicated surgeries, including LCs as it is the most common laparoscopic surgery being carried out in Sibu Hospital. Unpublished hospital data revealed that between 48 to 72 LCs are being performed annually since data collection began in 2010. Although major complications (e.g. adjacent organ injury) post-LC are rarely encountered in Sibu Hospital, relatively minor complications (e.g. excessive bleeding leading to prolonged theatre time) can still occur. In a bid to further reduce the complication rates of LC, we therefore decided to embark on a study to investigate any peri-operative advantage conferred on junior surgeons in performing LC using 3D visualisation as the majority of LCs in Sibu Hospital are carried out by junior surgeons.
- Conditions
- Complication Laparoscopic Cholecystectomy, Conversion Laparoscopic to Open Cholecystectomy
- Being tested
- 3D laparoscopic cholecystectomy
- Keywords
- 3D laparoscopic cholecystectomy, Junior surgeons, Complication, Conversion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy will be performed under 3D visualization as opposed to 2D visualization (conventional method). 3D supposedly provide sharper view with better depth perception and therefore might lead to reduce complication rates.
| Study group | Role | What they receive |
|---|---|---|
| 3D laparoscopic cholecystectomy | Experimental | Laparoscopic cholecystectomy will be performed under 3D visualisation. Receives: Procedure: 3D laparoscopic cholecystectomy |
| 2D laparoscopic cholecystectomy | No intervention | Laparoscopic cholecystectomy will be performed under 2D visualisation, the standard viewing method used during all laparoscopic surgeries currently. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
Intraoperative complications : Gallbladder perforation, adjacent organ injury, uncontrolled bleeding Post-operative : pain score, length of hospital stay, readmission, mortality
Measured: 6 months
Secondary outcomes (2)
Operative Time
Time taken between insertion of 4th port - cystic artery and cystic duct ligation - gallbladder full dissection.
Measured: 6 months
Conversion to open cholecystectomy
To compare the rate of conversion between each arm.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start1 Apr 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication Laparoscopic CholecystectomyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Centre, Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chea Chan Hooi, Clinical Research Centre, Malaysia
- Investigators
- Chan Hooi Chea, MS, Principal investigator, Ministry of Health, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143426
- Sponsor's protocol ID
- 001
- Status last verified
- Jan 2018
- First submitted
- 4 May 2017
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does 3D Visualisation Improve Performance of Laparoscopic Cholecystectomy by Junior Surgeons? A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03143426
- Acronym / sponsor ID
- 001
- Conditions
- Complication Laparoscopic Cholecystectomy, Conversion Laparoscopic to Open Cholecystectomy
- Keywords
- 3D laparoscopic cholecystectomy, Junior surgeons, Complication, Conversion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Clinical Research Centre, MalaysiaUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 8 May 2017 (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.
Laparoscopic cholecystectomy (LC) is currently the most commonly performed major abdominal surgery in Western countries. Ever since the introduction of laparoscopic surgery in the late 1980s, cholecystectomies are now routinely performed laparoscopically; concomitantly the introduction and refinement of other laparoscopic abdominal surgeries have rapidly progressed due to the early experience and safety profile seen in LC.
The introduction of stereoscopes which allow for 3D visual feedback has been postulated to overcome setbacks encountered in conventional 2-dimensional (2D) laparoscopic surgery. Since its introduction in the mid-2000s, 3D visualisation has been proven to be advantageous over 2D visualisation, especially so within the context of training junior surgeons in controlled, experimental settings. The body of evidence on benefits of 3D visualisation within the clinical setting, i.e. when applied on live patients in operating theatres, remains small and weak. The previous publications however did not extrapolate any potential benefits on patients' well-being in correlation to their reported benefits and neither did they explore any potential benefits in reducing operative complications.
We decided to embark on a study to investigate any peri-operative advantage conferred on junior surgeons in performing LC using 3D visualisation as the majority of LCs in Sibu Hospital are carried out by junior surgeons.
Detailed description
Laparoscopic cholecystectomy (LC) is currently the most commonly performed major abdominal surgery in Western countries.1,2 Ever since the introduction of laparoscopic surgery in the late 1980s, cholecystectomies are now routinely performed laparoscopically; concomitantly the introduction and refinement of other laparoscopic abdominal surgeries have rapidly progressed due to the early experience and safety profile seen in LC.
Although the benefits of LC are well described (e.g. decreased post-operative pain, decreased need for post-operative analgesia, shortened hospital stay and earlier return to full activity),3,4 it is not completely risk-free. The surgeon's experience, or rather the lack of, has been previously identified as one of the significant correlations to inadvertent visceral injury.5 According to the European Association for Endoscopic Surgery, a minimum of 20 LCs are necessary before a surgeon is deemed able to perform it safely.6 This is consistent with the concept of the learning curve as analysed by Moore and Bennett; they noted that 90% of iatrogenic bile duct injuries occurred within the first 30 cases of the operating surgeon's experience.7 Publications on LC learning curve have identified the risk of an iatrogenic bile duct injury as 0.17% - 0.35% after a surgeon's 50th case as opposed to 1.3 - 1.7% when fewer than 50 cases.7,8 These higher risks of iatrogenic injuries have been attributed to the major setbacks encountered during conventional laparoscopic surgery, chiefly the lack of depth perception and tactile sensory feedback to the operating surgeon thus risking inadvertent injury to surrounding structures and imprecise dissection within the Calot's triangle. While the importance of senior supervision and guidance are indispensible, the technical short-comings of conventional laparoscopic surgery, i.e. the lack of depth perception, have led to the development of technology to allow for 3-dimensional (3D) visualisation.
The introduction of stereoscopes which allow for 3D visual feedback has been postulated to overcome these setbacks encountered in conventional 2-dimensional (2D) laparoscopic surgery. Since its introduction in the mid-2000s, 3D visualisation has been proven to be advantageous over 2D visualisation, especially so within the context of training junior surgeons in controlled, experimental settings.9,10 The body of evidence on benefits of 3D visualisation within the clinical setting, i.e. when applied on live patients in operating theatres, remains small and weak. These were mostly small, single-institution studies focused only on specific laparoscopic procedures such as hernia repair, distal gastrectomies,11 urologic12,13,14 and gynaecologic15,16 procedures.
Sakata and workers also believed that advantages conferred by 3D visualisation has been underreported and undermined by flawed study designs and utilised mostly earlier generation of 3D stereoscopes that has since been phased out, therefore undermining the clinical potential of 3D laparoscopy.17 Experience with utilisation of 3D visualisation in performing LC is still in its infancy and to the authors' knowledge, there have been no unfavourable results reported with the use of 3D visualisation for laparoscopic surgery. Data on direct comparison of 2D against 3D LC is still scarce; there are only three such studies and all demonstrated superiority of 3D over 2D visualisation in LC. These studies, though originating from tertiary institutions, are hampered by the limited numbers of patients operated using 3D visualisation (n = 8, 15 \& 40 respectively).11,18,19 The third study,19 reported advantages of 3D visualisation conferred to junior surgeons in terms of reducing operative time, better depth perception and reduced subjective visual strain. The authors however did not extrapolate any potential benefits on patients' well-being in correlation to their reported benefits and neither did they explore any potential benefits in reducing operative complications.
Sibu Hospital is a 534-bedded tertiary and referral hospital for advanced specialised health care within the central region of Sarawak. Data from 2007 estimated that Sibu Hospital serves a population of at least 500 000 and this population is believed to have doubled to date.20 The department of general surgery is headed by a senior consultant surgeon (AD) and this department also serves as a training center for junior surgeons who have just completed their post-graduate qualifications. Under the tutelage of at least one senior consultant general surgeon, these junior surgeons are mentored through their early learning curves in performing major complicated surgeries, including LCs as it is the most common laparoscopic surgery being carried out in Sibu Hospital. Unpublished hospital data revealed that between 48 to 72 LCs are being performed annually since data collection began in 2010. Although major complications (e.g. adjacent organ injury) post-LC are rarely encountered in Sibu Hospital, relatively minor complications (e.g. excessive bleeding leading to prolonged theatre time) can still occur. In a bid to further reduce the complication rates of LC, we therefore decided to embark on a study to investigate any peri-operative advantage conferred on junior surgeons in performing LC using 3D visualisation as the majority of LCs in Sibu Hospital are carried out by junior surgeons.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D laparoscopic cholecystectomy | Experimental | Procedure: 3D laparoscopic cholecystectomyLaparoscopic cholecystectomy will be performed under 3D visualisation. |
| 2D laparoscopic cholecystectomy | No intervention | –Laparoscopic cholecystectomy will be performed under 2D visualisation, the standard viewing method used during all laparoscopic surgeries currently. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients scheduled to undergo elective LC
Key exclusion criteria (7 listed)
- Patients below 18 years-old
- Patients who declined to join the study
- Patients with contraindications to undergo laparoscopic surgery (e.g. congestive cardiac failure, severe respiratory disease, uncorrected coagulopathy)
- Patients with acute cholecystitis, gallbladder neck adherent to main biliary tree or dense omental adhesion to gallbladder
- Patients with gallbladder tumour (suspected or confirmed)
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 cholecystectomyLaparoscopic cholecystectomy will be performed under 3D visualization as opposed to 2D visualization (conventional method). 3D supposedly provide sharper view with better depth perception and therefore might lead to reduce complication rates. | Procedure or surgery | 3D laparoscopic cholecystectomy |
Primary outcome
Complication rate
Time frame: 6 months
Intraoperative complications : Gallbladder perforation, adjacent organ injury, uncontrolled bleeding Post-operative : pain score, length of hospital stay, readmission, mortality
2 secondary outcomes
Operative Time
Time frame: 6 months
Conversion to open cholecystectomy
Time frame: 6 months
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 26 Jan 2018.
- Individual participant dataSharing planned: No
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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
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Subcostal TAP Block Versus Combined Subcostal TAP and Recto-Intercostal Fascial Plane Block for Analgesia After Laparoscopic Cholecystectomy
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Recto-Intercostal Fascial Plane and External Oblique Intercostal Blocks for Pain in Laparoscopic Cholecystectomyin Laparoscopic Cholecystectomy
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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.
Chan Hooi Chea, MS principal investigator
Ministry of Health, Malaysia
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 cholecystectomy in people with Complication Laparoscopic Cholecystectomy and Conversion Laparoscopic to Open Cholecystectomy, run by Clinical Research Centre, Malaysia at 1 site in Malaysia.
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 7 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 26 Jan 2018. 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 Malaysia. 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?
Complication rate (time frame: 6 months). 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 26 Jan 2018.