CholelithiasisELECTRO-LCNCT07888491
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
An observational study of Cholelithiasis, run by University Hospital of Split at 1 site in Croatia.
Trial summary
This prospective observational study will examine how electrosurgical activation patterns during elective laparoscopic cholecystectomy are associated with surgeon experience and intraoperative difficulty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Elective laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 165 participants
- Where
- 1 siteCroatia
- Study dates
- 15 Oct 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult patients undergoing elective laparoscopic cholecystectomy in the regular operating program at the Department of Surgery, Division of Abdominal Surgery, University Hospital of Split. Consecutive eligible cases will be sampled within predefined surgeon cohorts. Male sex, age over 65 years, and thickened gallbladder wall are not exclusion criteria and will be recorded as potential covariates. An unexpectedly pronounced inflammatory or acute-like intraoperative finding does not itself exclude an otherwise elective case; difficulty will be captured using the Parkland grade.
Who may be able to join
- Age 18 years or older
- Elective laparoscopic cholecystectomy in the regular operating program
- Written informed consent
- The designated study surgeon performs the entire analyzed operative segment
- Technically usable synchronized audio-video recording with known electrosurgical generator settings and instrument
Who cannot join
- Emergency surgery or clinical acute cholecystitis as the indication for surgery
- Previous endoscopic retrograde cholangiopancreatography (ERCP)
- Previous upper abdominal surgery
- Open cholecystectomy from the outset or a major combined operation that materially alters the operative course
- Predominant use of another energy device that is not comparable with the standardized generator
- Change or takeover of the operating surgeon within the analyzed segment without the possibility of clear separation
- Technically unusable audio or video recording or missing initial image required for Parkland grading
- Withdrawal of informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital of Split
Split, Split-Dalmatia County, 21000
Ognjen Barcot, MD, PhD, +385 21 556 691, ognjen.barcot@kbsplit.hr
About this study
Official title: Electrosurgical Activation Patterns and the Learning Curve in Elective Laparoscopic Cholecystectomy: A Two-Stage Prospective Observational Study
This prospective observational study will examine how electrosurgical activation patterns during elective laparoscopic cholecystectomy are associated with surgeon experience and intraoperative difficulty. Adult patients scheduled for elective laparoscopic cholecystectomy at University Hospital of Split will receive standard clinical care; the study does not assign an intervention or change the surgical technique. A fixed camera will record only the laparoscopic monitor, and a directional microphone will record the audible signals of the electrosurgical generator. The study includes a cross-sectional comparison among surgeons with different cumulative experience and a longitudinal assessment of developing surgeons as they gain additional experience. Activation patterns will be analyzed separately during dissection of the hepatocystic triangle and separation of the gallbladder from the liver bed. Intraoperative difficulty will be graded from the initial operative video using the Parkland Grading Scale by two independent assessors, with adjudication when needed.
Read the detailed description
This is a single-center, two-stage prospective observational cohort study conducted during elective laparoscopic cholecystectomy. Eligible cases will be included consecutively within predefined surgeon cohorts. Clinical care, case allocation, supervision, operative technique, and decisions regarding conversion or surgeon takeover will not be altered by the study.
Stage 1 is a cross-sectional comparison of 48 evaluable operations, with six operations performed by each of eight surgeons who have different levels of cumulative laparoscopic cholecystectomy experience. Stage 2 is a longitudinal assessment comprising 100 operations performed by four developing surgeons followed through 25 consecutive evaluable operations each, 12 operations performed by two new beginner surgeons, and six operations performed by an experienced reference surgeon. The first six operations of each longitudinally followed surgeon are also included in Stage 1. The umbrella study therefore targets at least 142 unique evaluable operations and anticipates enrollment of 165 patients to allow for technical losses and exclusions.
A Xiaomi Redmi Note 14 Pro+ 5G camera will be fixed outside the sterile field and directed only at the laparoscopic monitor. A BOYA BY-MM1 AI USB-C directional microphone will be positioned toward the loudspeaker of the Valleylab Force FX-C electrosurgical generator. Standard generator settings are Fulgurate coagulation at 65 W, Pure Cut at 35 W, and audible volume at 75%. Any deviation from the standardized equipment or settings will be recorded.
After surgery, investigators will identify two predefined operative segments from the video. Segment A begins with the first electrosurgical activation on tissue in the hepatocystic triangle after exposure has been achieved and ends with the first clip application to a cystic structure. Segment B begins with the first electrosurgical activation used to separate the gallbladder from the liver and ends with complete gallbladder separation or the beginning of final liver-bed hemostasis. WAV audio will be exported for each segment. A locked local Python/Streamlit application will identify individual electrosurgical activations and derive activation counts, durations, intervals, rates, and total activation time.
The initial appearance of the gallbladder will be graded on the Parkland Grading Scale (grades 1 to 5) before substantial dissection. Two assessors who are blinded to the audio-analysis results will grade each case independently. Disagreement will be adjudicated by an additional qualified investigator who did not perform that operation.
The main analyses will use mixed-effects models to assess associations of cumulative operative experience, Parkland grade, operative segment, and the experience-by-Parkland interaction with electrosurgical activation patterns. Longitudinal models will account for repeated operations nested within surgeon. Effect estimates will be reported with 95% confidence intervals.
- Conditions
- Cholelithiasis
- Being tested
- Elective laparoscopic cholecystectomy
- Keywords
- Laparoscopic cholecystectomy, Electrosurgery, Surgical learning curve, Parkland Grading Scale, Audio analysis
- Medical subject headings
- Cholelithiasis, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective laparoscopic cholecystectomyProcedure or surgery
Standard-of-care elective laparoscopic cholecystectomy. The study does not assign or modify the surgical procedure, operative technique, supervision, or clinical decisions. Investigators will observe electrosurgical activation patterns during two predefined operative segments using synchronized recording of the laparoscopic monitor and electrosurgical generator audio.
| Study group | Role | What they receive |
|---|---|---|
| Elective Laparoscopic Cholecystectomy Cohort | Adult patients undergoing elective laparoscopic cholecystectomy under standard clinical care. Consecutive eligible cases will be enrolled within predefined surgeon cohorts. The exposures of interest are the operating surgeon's cumulative laparoscopic cholecystectomy experience and the Parkland grade of intraoperative difficulty. Electrosurgical activation patterns will be derived from synchronized recordings of the laparoscopic monitor and generator audio. Receives: Procedure: Elective laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Duration of Coagulation-Mode Electrosurgical Activations During Segment A
For each operation, the median duration in seconds of individual, clearly separated coagulation-mode activations detected by the locked audio-analysis algorithm during hepatocystic triangle dissection (Segment A). Segment A must contain at least three coagulation-mode activations. The operation is the unit of analysis.
Measured: During Segment A of the index laparoscopic cholecystectomy
Longitudinal Change in Median Coagulation Activation Duration During Segment A
Change in the operation-level median duration of individual coagulation-mode activations during Segment A for the four longitudinally followed developing surgeons, estimated per 10 additional evaluable laparoscopic cholecystectomies. The effect will be reported as absolute and percentage change with a 95% confidence interval, adjusted for Parkland grade.
Measured: From the first through the 25th evaluable operation for each longitudinally followed surgeon, up to 31 December 2028
Secondary outcomes (13)
Number of Coagulation-Mode Activations per Minute by Operative Segment
For each operation, the number of detected coagulation-mode activations divided by segment duration in minutes, calculated separately for Segment A and Segment B.
Measured: During Segments A and B of the index laparoscopic cholecystectomy
Total Coagulation Activation Time per Minute by Operative Segment
For each operation, the summed duration in seconds of all coagulation-mode activations divided by segment duration in minutes, calculated separately for Segment A and Segment B.
Measured: During Segments A and B of the index laparoscopic cholecystectomy
Variability of Coagulation Activation Duration by Operative Segment
For each operation, variability in the duration of individual coagulation-mode activations will be summarized using the interquartile range and median absolute deviation, separately for Segment A and Segment B.
Measured: During Segments A and B of the index laparoscopic cholecystectomy
Proportion of Coagulation Activations Longer Than 2 Seconds by Operative Segment
For each operation, the number of coagulation-mode activations lasting more than 2 seconds divided by the total number of coagulation-mode activations, expressed as a percentage and calculated separately for Segment A and Segment B.
Measured: During Segments A and B of the index laparoscopic cholecystectomy
Median Inter-Activation Interval by Operative Segment
For each operation, the median time in seconds from the end of one coagulation-mode activation to the start of the next coagulation-mode activation, calculated separately for Segment A and Segment B.
Measured: During Segments A and B of the index laparoscopic cholecystectomy
Duration of Each Operative Segment
Elapsed time in seconds from the predefined start to the predefined end of Segment A and Segment B, calculated separately for each segment.
Measured: During Segments A and B of the index laparoscopic cholecystectomy
Number of Cutting-Mode Electrosurgical Activations by Operative Segment
For each operation, the number of detected cutting-mode electrosurgical activations, reported descriptively and calculated separately for Segment A and Segment B.
Measured: During Segments A and B of the index laparoscopic cholecystectomy
Median Duration of Cutting-Mode Electrosurgical Activations by Operative Segment
For each operation, the median duration in seconds of individual cutting-mode electrosurgical activations, reported descriptively and calculated separately for Segment A and Segment B.
Measured: During Segments A and B of the index laparoscopic cholecystectomy
Longitudinal Change in Coagulation Activation Rate
Change in the number of coagulation-mode activations per minute among the four longitudinally followed developing surgeons, estimated per 10 additional evaluable laparoscopic cholecystectomies and evaluated by operative segment.
Measured: From the first through the 25th evaluable operation for each longitudinally followed surgeon, up to 31 December 2028
Longitudinal Change in Total Coagulation Activation Time per Minute
Change in the total coagulation-mode activation time in seconds per minute among the four longitudinally followed developing surgeons, estimated per 10 additional evaluable laparoscopic cholecystectomies and evaluated by operative segment.
Measured: From the first through the 25th evaluable operation for each longitudinally followed surgeon, up to 31 December 2028
Longitudinal Change in Variability of Coagulation Activation Duration
Change in the interquartile range and median absolute deviation of coagulation-mode activation duration among the four longitudinally followed developing surgeons, estimated across the sequence of evaluable operations and evaluated by operative segment.
Measured: From the first through the 25th evaluable operation for each longitudinally followed surgeon, up to 31 December 2028
Longitudinal Change in the Proportion of Coagulation Activations Longer Than 2 Seconds
Change in the percentage of coagulation-mode activations lasting more than 2 seconds among the four longitudinally followed developing surgeons, estimated across the sequence of evaluable operations and evaluated by operative segment.
Measured: From the first through the 25th evaluable operation for each longitudinally followed surgeon, up to 31 December 2028
Longitudinal Change in Operative Segment Duration
Change in the duration in seconds of Segment A and Segment B among the four longitudinally followed developing surgeons, estimated across the sequence of evaluable laparoscopic cholecystectomies.
Measured: From the first through the 25th evaluable operation for each longitudinally followed surgeon, up to 31 December 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start15 Oct 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CholelithiasisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ognjen Barcot, MD, PhD, Study director, University Hospital of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888491
- Sponsor's protocol ID
- KBCST-ELECTROLC-2026-01
- Acronym
- ELECTRO-LC
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lombardi PM, Mazzola M, Veronesi V, Granieri S, Cioffi SPB, Baia M, Del Prete L, Bernasconi DP, Danelli P, Ferrari G. Learning curve of laparoscopic cholecystectomy: a risk-adjusted cumulative summation (RA-CUSUM) analysis of six general surgery residents. Surg Endosc. 2023 Oct;37(10):8133-8143. doi: 10.1007/s00464-023-10345-x. Epub 2023 Sep 8.
PubMed 37684403Madni TD, Nakonezny PA, Barrios E, Imran JB, Clark AT, Taveras L, Cunningham HB, Christie A, Eastman AL, Minshall CT, Luk S, Minei JP, Phelan HA, Cripps MW. Prospective validation of the Parkland Grading Scale for Cholecystitis. Am J Surg. 2019 Jan;217(1):90-97. doi: 10.1016/j.amjsurg.2018.08.005. Epub 2018 Aug 21.
PubMed 30190078Meeuwsen FC, Guedon ACP, Arkenbout EA, van der Elst M, Dankelman J, van den Dobbelsteen JJ. The Art of Electrosurgery: Trainees and Experts. Surg Innov. 2017 Aug;24(4):373-378. doi: 10.1177/1553350617705207. Epub 2017 Apr 24.
PubMed 28438057
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrosurgical Activation Patterns and the Learning Curve in Elective Laparoscopic Cholecystectomy: A Two-Stage Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07888491
- Acronym / sponsor ID
- ELECTRO-LC / KBCST-ELECTROLC-2026-01
- Conditions
- Cholelithiasis
- Keywords
- Laparoscopic cholecystectomy, Electrosurgery, Surgical learning curve, Parkland Grading Scale, Audio analysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Oct 2026 (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.
This prospective observational study will examine how electrosurgical activation patterns during elective laparoscopic cholecystectomy are associated with surgeon experience and intraoperative difficulty. Adult patients scheduled for elective laparoscopic cholecystectomy at University Hospital of Split will receive standard clinical care; the study does not assign an intervention or change the surgical technique. A fixed camera will record only the laparoscopic monitor, and a directional microphone will record the audible signals of the electrosurgical generator. The study includes a cross-sectional comparison among surgeons with different cumulative experience and a longitudinal assessment of developing surgeons as they gain additional experience. Activation patterns will be analyzed separately during dissection of the hepatocystic triangle and separation of the gallbladder from the liver bed. Intraoperative difficulty will be graded from the initial operative video using the Parkland Grading Scale by two independent assessors, with adjudication when needed.
Detailed description
This is a single-center, two-stage prospective observational cohort study conducted during elective laparoscopic cholecystectomy. Eligible cases will be included consecutively within predefined surgeon cohorts. Clinical care, case allocation, supervision, operative technique, and decisions regarding conversion or surgeon takeover will not be altered by the study.
Stage 1 is a cross-sectional comparison of 48 evaluable operations, with six operations performed by each of eight surgeons who have different levels of cumulative laparoscopic cholecystectomy experience. Stage 2 is a longitudinal assessment comprising 100 operations performed by four developing surgeons followed through 25 consecutive evaluable operations each, 12 operations performed by two new beginner surgeons, and six operations performed by an experienced reference surgeon. The first six operations of each longitudinally followed surgeon are also included in Stage 1. The umbrella study therefore targets at least 142 unique evaluable operations and anticipates enrollment of 165 patients to allow for technical losses and exclusions.
A Xiaomi Redmi Note 14 Pro+ 5G camera will be fixed outside the sterile field and directed only at the laparoscopic monitor. A BOYA BY-MM1 AI USB-C directional microphone will be positioned toward the loudspeaker of the Valleylab Force FX-C electrosurgical generator. Standard generator settings are Fulgurate coagulation at 65 W, Pure Cut at 35 W, and audible volume at 75%. Any deviation from the standardized equipment or settings will be recorded.
After surgery, investigators will identify two predefined operative segments from the video. Segment A begins with the first electrosurgical activation on tissue in the hepatocystic triangle after exposure has been achieved and ends with the first clip application to a cystic structure. Segment B begins with the first electrosurgical activation used to separate the gallbladder from the liver and ends with complete gallbladder separation or the beginning of final liver-bed hemostasis. WAV audio will be exported for each segment. A locked local Python/Streamlit application will identify individual electrosurgical activations and derive activation counts, durations, intervals, rates, and total activation time.
The initial appearance of the gallbladder will be graded on the Parkland Grading Scale (grades 1 to 5) before substantial dissection. Two assessors who are blinded to the audio-analysis results will grade each case independently. Disagreement will be adjudicated by an additional qualified investigator who did not perform that operation.
The main analyses will use mixed-effects models to assess associations of cumulative operative experience, Parkland grade, operative segment, and the experience-by-Parkland interaction with electrosurgical activation patterns. Longitudinal models will account for repeated operations nested within surgeon. Effect estimates will be reported with 95% confidence intervals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Laparoscopic Cholecystectomy Cohort | – | Procedure: Elective laparoscopic cholecystectomyAdult patients undergoing elective laparoscopic cholecystectomy under standard clinical care. Consecutive eligible cases will be enrolled within predefined surgeon cohorts. The exposures of interest are the operating surgeon's cumulative laparoscopic cholecystectomy experience and the Parkland grade of intraoperative difficulty. Electrosurgical activation patterns will be derived from synchronized recordings of the laparoscopic monitor and generator audio. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective laparoscopic cholecystectomy in the regular operating program at the Department of Surgery, Division of Abdominal Surgery, University Hospital of Split. Consecutive eligible cases will be sampled within predefined surgeon cohorts. Male sex, age over 65 years, and thickened gallbladder wall are not exclusion criteria and will be recorded as potential covariates. An unexpectedly pronounced inflammatory or acute-like intraoperative finding does not itself exclude an otherwise elective case; difficulty will be captured using the Parkland grade.
Key inclusion criteria (5 listed)
- Age 18 years or older
- Elective laparoscopic cholecystectomy in the regular operating program
- Written informed consent
- The designated study surgeon performs the entire analyzed operative segment
- Technically usable synchronized audio-video recording with known electrosurgical generator settings and instrument
Key exclusion criteria (8 listed)
- Emergency surgery or clinical acute cholecystitis as the indication for surgery
- Previous endoscopic retrograde cholangiopancreatography (ERCP)
- Previous upper abdominal surgery
- Open cholecystectomy from the outset or a major combined operation that materially alters the operative course
- Predominant use of another energy device that is not comparable with the standardized generator
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 |
|---|---|---|
| Elective laparoscopic cholecystectomyStandard-of-care elective laparoscopic cholecystectomy. The study does not assign or modify the surgical procedure, operative technique, supervision, or clinical decisions. Investigators will observe electrosurgical activation patterns during two predefined operative segments using synchronized recording of the laparoscopic monitor and electrosurgical generator audio. | Procedure or surgery | Elective Laparoscopic Cholecystectomy Cohort |
Primary outcome
Median Duration of Coagulation-Mode Electrosurgical Activations During Segment A
Time frame: During Segment A of the index laparoscopic cholecystectomy
For each operation, the median duration in seconds of individual, clearly separated coagulation-mode activations detected by the locked audio-analysis algorithm during hepatocystic triangle dissection (Segment A). Segment A must contain at least three coagulation-mode activations. The operation is the unit of analysis.
Longitudinal Change in Median Coagulation Activation Duration During Segment A
Time frame: From the first through the 25th evaluable operation for each longitudinally followed surgeon, up to 31 December 2028
Change in the operation-level median duration of individual coagulation-mode activations during Segment A for the four longitudinally followed developing surgeons, estimated per 10 additional evaluable laparoscopic cholecystectomies. The effect will be reported as absolute and percentage change with a 95% confidence interval, adjusted for Parkland grade.
13 secondary outcomes
Number of Coagulation-Mode Activations per Minute by Operative Segment
Time frame: During Segments A and B of the index laparoscopic cholecystectomy
Total Coagulation Activation Time per Minute by Operative Segment
Time frame: During Segments A and B of the index laparoscopic cholecystectomy
Variability of Coagulation Activation Duration by Operative Segment
Time frame: During Segments A and B of the index laparoscopic cholecystectomy
Proportion of Coagulation Activations Longer Than 2 Seconds by Operative Segment
Time frame: During Segments A and B of the index laparoscopic cholecystectomy
Median Inter-Activation Interval by Operative Segment
Time frame: During Segments A and B of the index laparoscopic cholecystectomy
Duration of Each Operative Segment
Time frame: During Segments A and B of the index laparoscopic cholecystectomy
Number of Cutting-Mode Electrosurgical Activations by Operative Segment
Time frame: During Segments A and B of the index laparoscopic cholecystectomy
Median Duration of Cutting-Mode Electrosurgical Activations by Operative Segment
Time frame: During Segments A and B of the index laparoscopic cholecystectomy
Longitudinal Change in Coagulation Activation Rate
Time frame: From the first through the 25th evaluable operation for each longitudinally followed surgeon, up to 31 December 2028
Longitudinal Change in Total Coagulation Activation Time per Minute
Time frame: From the first through the 25th evaluable operation for each longitudinally followed surgeon, up to 31 December 2028
Longitudinal Change in Variability of Coagulation Activation Duration
Time frame: From the first through the 25th evaluable operation for each longitudinally followed surgeon, up to 31 December 2028
Longitudinal Change in the Proportion of Coagulation Activations Longer Than 2 Seconds
Time frame: From the first through the 25th evaluable operation for each longitudinally followed surgeon, up to 31 December 2028
Longitudinal Change in Operative Segment Duration
Time frame: From the first through the 25th evaluable operation for each longitudinally followed surgeon, up to 31 December 2028
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 37684403Lombardi PM, Mazzola M, Veronesi V, Granieri S, Cioffi SPB, Baia M, Del Prete L, Bernasconi DP, Danelli P, Ferrari G. Learning curve of laparoscopic cholecystectomy: a risk-adjusted cumulative summation (RA-CUSUM) analysis of six general surgery residents. Surg Endosc. 2023 Oct;37(10):8133-8143. doi: 10.1007/s00464-023-10345-x. Epub 2023 Sep 8.
- Background: PubMed 30190078Madni TD, Nakonezny PA, Barrios E, Imran JB, Clark AT, Taveras L, Cunningham HB, Christie A, Eastman AL, Minshall CT, Luk S, Minei JP, Phelan HA, Cripps MW. Prospective validation of the Parkland Grading Scale for Cholecystitis. Am J Surg. 2019 Jan;217(1):90-97. doi: 10.1016/j.amjsurg.2018.08.005. Epub 2018 Aug 21.
- Background: PubMed 28438057Meeuwsen FC, Guedon ACP, Arkenbout EA, van der Elst M, Dankelman J, van den Dobbelsteen JJ. The Art of Electrosurgery: Trainees and Experts. Surg Innov. 2017 Aug;24(4):373-378. doi: 10.1177/1553350617705207. Epub 2017 Apr 24.
- Individual participant dataSharing planned: Undecided
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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.
Ognjen Barcot, MD, PhD study director
University Hospital of Split
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholelithiasis, run by University Hospital of Split at 1 site in Croatia.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. 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 Croatia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ognjen Barcot, MD, PhD (+385 21 556 691, ognjen.barcot@kbsplit.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Duration of Coagulation-Mode Electrosurgical Activations During Segment A (time frame: During Segment A of the index laparoscopic cholecystectomy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07888491, which also lists 3 linked publications.
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 22 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.