Laparoscopic CholecystectomyNCT04282759
Can Laparoscopic Cholecystectomy Difficulty Score Predict Difficult Surgery
An observational study of Laparoscopic Cholecystectomy, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy is the gold standard treatment method in symptomatic gallstone disease. However, complications that develop due to being a technical procedure tend to be more complex and more morbid-estimating how difficult the surgery will be before the operation will enable us to be more prepared both… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- How many people
- 330 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 20 Aug 2020
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is comprised of patients between the ages of 18-100, who are referred to the general surgery clinic for laparoscopic cholecystectomy.
Who may be able to join
- Patients who will be operated for biliary colic, chronic cholecystitis or symptomatic cholelithiasis,
- Patients who have been treated with antibiotics before with the diagnosis of cholecystitis and have been planned for elective cholecystectomy,
- Patients diagnosed with acute cholecystitis according to Tokyo criteria and cholecystectomy planned due to acute cholecystitis
Who cannot join
- Patients under the age of 18,
- Patients over 100 years old,
- Patients diagnosed with choledocholithiasis with magnetic resonance cholangiopancreatography (MRCP),
- Patients with cholangitis
- Patients who have undergone endoscopic retrograde cholangiopancreatography (ERCP),
- Patients who have undergone biliary system intervention before,
- Patients scheduled for operation open cholecystectomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Training and Research Hospital
Konya, 42090
About this study
Official title: Difficulty in Laparoscopic Cholecystectomy Score Can Determine the Operative Challenge.
Laparoscopic cholecystectomy is the gold standard treatment method in symptomatic gallstone disease. However, complications that develop due to being a technical procedure tend to be more complex and more morbid-estimating how difficult the surgery will be before the operation will enable us to be more prepared both in terms of patient counseling and surgical team selection. Such a prediction will minimize the risk of complications and morbidity.
In our study, investigators used the scoring system "How to predict difficult laparoscopic cholecystectomy? Proposal for a simple preoperative scoring system?" which was published in "The American Journal of Surgery" in November 2016. Investigators wanted to evaluate prospectively adequate "Laparoscopic Cholecystectomy Difficulty Score," which was developed retrospectively, in determining the surgical difficulty preoperatively.
Read the detailed description
ETHICAL BOARD APPROVAL
Konya Chamber of Commerce Education and Health Foundation was found ethically appropriate for the study according to the decision of Karatay University Ethical Board Presidency dated 18.06.2019 and numbered 2019/0051.
FEATURES OF THE STUDY AND SELECTION OF PATIENTS
Patients who were to be operated due to symptomatic cholelithiasis between 01.03.2020 and 31.07.2020 at the Health Sciences University (SBU) Konya Training and Research Hospital (KEAH) were included in the study. The study was done prospectively.
Laparoscopic Cholecystectomy Difficulty Score (DSLC) developed in the reference study will be used. The sex of the patients and whether they had an attack of cholecystitis will be recorded. Neutrophil count, fibrinogen, and ALP levels will be recorded from preoperatively routine blood tests. DSLC score will be calculated before the patient goes into surgery. How successful the scoring system is in determining the difficulty of the operation in the postoperative period will be analyzed statistically.
Thirteen surgeons will be included in the study. Based on the last ten surgery times, where each surgeon has no problems and has no technical difficulties, the average operation time will be calculated for each surgeon individually. In the reference study, it has been accepted that the surgeon's duration is more than 1.5 times or challenging to undergo open surgery. In our study, it will be considered as a difficult operation to exceed or exceed 1.5 times the surgeon's duration. Other than that, it will be considered a smooth operation. The biliary tract injuries that occurred in exposed cases will be classified according to the Strasberg classification. In the reference study, statistically significant score groups were formed as low risk of 0 points, medium risk of 1-4 points, high risk of 5-9 points, and a very high risk of 10 points. In our study, these score groups will be created, and statistical analysis will be made. Also, ROC (Reciever Operator Characteristics Curve) curve will be created with the scores obtained from the scoring system, and the specificity and sensitivity of the scoring system will be statistically put.
- Conditions
- Laparoscopic Cholecystectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical recording of Difficulty Score of Laparoscopic Cholecystectomy (DSLC)
Laparoscopic cholecystectomy scores of patients included in the study will be recorded. The relationship between the scoring system and the fact that the cases are easy or difficult will be analyzed statistically, in which predictive values determine the difficulty of the operation. The study will be terminated with the completion of the analysis.
Measured: The period of the study is between 1 March 2020 and 15 August 2020.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 Mar 2020
- Primary completion20 Aug 2020
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erguvan Nalıncıoğlu, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282759
- Sponsor's protocol ID
- KonyaHPRC
- Status last verified
- Oct 2020
- First submitted
- 21 Feb 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bourgouin S, Mancini J, Monchal T, Calvary R, Bordes J, Balandraud P. How to predict difficult laparoscopic cholecystectomy? Proposal for a simple preoperative scoring system. Am J Surg. 2016 Nov;212(5):873-881. doi: 10.1016/j.amjsurg.2016.04.003. Epub 2016 Jun 1.
PubMed 27329073Sugrue M, Coccolini F, Bucholc M, Johnston A; Contributors from WSES. Intra-operative gallbladder scoring predicts conversion of laparoscopic to open cholecystectomy: a WSES prospective collaborative study. World J Emerg Surg. 2019 Mar 14;14:12. doi: 10.1186/s13017-019-0230-9. eCollection 2019.
PubMed 30911325
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difficulty in Laparoscopic Cholecystectomy Score Can Determine the Operative Challenge.
- ClinicalTrials.gov ID
- NCT04282759
- Acronym / sponsor ID
- KonyaHPRC
- Conditions
- Laparoscopic Cholecystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 25 Feb 2020 (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 is the gold standard treatment method in symptomatic gallstone disease. However, complications that develop due to being a technical procedure tend to be more complex and more morbid-estimating how difficult the surgery will be before the operation will enable us to be more prepared both in terms of patient counseling and surgical team selection. Such a prediction will minimize the risk of complications and morbidity.
In our study, investigators used the scoring system "How to predict difficult laparoscopic cholecystectomy? Proposal for a simple preoperative scoring system?" which was published in "The American Journal of Surgery" in November 2016. Investigators wanted to evaluate prospectively adequate "Laparoscopic Cholecystectomy Difficulty Score," which was developed retrospectively, in determining the surgical difficulty preoperatively.
Detailed description
ETHICAL BOARD APPROVAL
Konya Chamber of Commerce Education and Health Foundation was found ethically appropriate for the study according to the decision of Karatay University Ethical Board Presidency dated 18.06.2019 and numbered 2019/0051.
FEATURES OF THE STUDY AND SELECTION OF PATIENTS
Patients who were to be operated due to symptomatic cholelithiasis between 01.03.2020 and 31.07.2020 at the Health Sciences University (SBU) Konya Training and Research Hospital (KEAH) were included in the study. The study was done prospectively.
Laparoscopic Cholecystectomy Difficulty Score (DSLC) developed in the reference study will be used. The sex of the patients and whether they had an attack of cholecystitis will be recorded. Neutrophil count, fibrinogen, and ALP levels will be recorded from preoperatively routine blood tests. DSLC score will be calculated before the patient goes into surgery. How successful the scoring system is in determining the difficulty of the operation in the postoperative period will be analyzed statistically.
Thirteen surgeons will be included in the study. Based on the last ten surgery times, where each surgeon has no problems and has no technical difficulties, the average operation time will be calculated for each surgeon individually. In the reference study, it has been accepted that the surgeon's duration is more than 1.5 times or challenging to undergo open surgery. In our study, it will be considered as a difficult operation to exceed or exceed 1.5 times the surgeon's duration. Other than that, it will be considered a smooth operation. The biliary tract injuries that occurred in exposed cases will be classified according to the Strasberg classification. In the reference study, statistically significant score groups were formed as low risk of 0 points, medium risk of 1-4 points, high risk of 5-9 points, and a very high risk of 10 points. In our study, these score groups will be created, and statistical analysis will be made. Also, ROC (Reciever Operator Characteristics Curve) curve will be created with the scores obtained from the scoring system, and the specificity and sensitivity of the scoring system will be statistically put.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is comprised of patients between the ages of 18-100, who are referred to the general surgery clinic for laparoscopic cholecystectomy.
Key inclusion criteria (3 listed)
- Patients who will be operated for biliary colic, chronic cholecystitis or symptomatic cholelithiasis,
- Patients who have been treated with antibiotics before with the diagnosis of cholecystitis and have been planned for elective cholecystectomy,
- Patients diagnosed with acute cholecystitis according to Tokyo criteria and cholecystectomy planned due to acute cholecystitis
Key exclusion criteria (7 listed)
- Patients under the age of 18,
- Patients over 100 years old,
- Patients diagnosed with choledocholithiasis with magnetic resonance cholangiopancreatography (MRCP),
- Patients with cholangitis
- Patients who have undergone endoscopic retrograde cholangiopancreatography (ERCP),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numerical recording of Difficulty Score of Laparoscopic Cholecystectomy (DSLC)
Time frame: The period of the study is between 1 March 2020 and 15 August 2020.
Laparoscopic cholecystectomy scores of patients included in the study will be recorded. The relationship between the scoring system and the fact that the cases are easy or difficult will be analyzed statistically, in which predictive values determine the difficulty of the operation. The study will be terminated with the completion of the analysis.
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 20 Oct 2020.
- Background: PubMed 27329073Bourgouin S, Mancini J, Monchal T, Calvary R, Bordes J, Balandraud P. How to predict difficult laparoscopic cholecystectomy? Proposal for a simple preoperative scoring system. Am J Surg. 2016 Nov;212(5):873-881. doi: 10.1016/j.amjsurg.2016.04.003. Epub 2016 Jun 1.
- Background: PubMed 30911325Sugrue M, Coccolini F, Bucholc M, Johnston A; Contributors from WSES. Intra-operative gallbladder scoring predicts conversion of laparoscopic to open cholecystectomy: a WSES prospective collaborative study. World J Emerg Surg. 2019 Mar 14;14:12. doi: 10.1186/s13017-019-0230-9. eCollection 2019.
- 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. 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?
An observational study of Laparoscopic Cholecystectomy, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
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 3 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 20 Oct 2020. 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 Turkey (Türkiye). 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?
Numerical recording of Difficulty Score of Laparoscopic Cholecystectomy (DSLC) (time frame: The period of the study is between 1 March 2020 and 15 August 2020.). 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 NCT04282759, which also lists 2 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 20 Oct 2020.