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IRCT20201013049017N3 IRCT 2022-10-12 Esfahan University of Medical Sciences Evaluation of the time of cholecystectomy after ERCP Evaluation of the outcomes of early cholecystectomy compared to delayed cholecystectomy after ERCP 2022-09-23 anticipated 188 Complete https://irct.ir/trial/63670 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For sampling, the method of double random blocks with SPSS software is used. In this way, two people who come for surgery are considered as one block until the number of blocks reaches 94. Then one person from each block is randomly assigned by the early method and one person by the delayed method, Blinding description: Participants are randomly assigned to receive one type of intervention, and only researchers know which participants are in which group, but participants do not know. N/A Cholecystitis,Choldocolithiasis. Intervention 1: The first intervention group: early cholecystectomy - in this group, the time interval between ERCP and cholecystectomy is less than 6 days. All patients are NPO 6 hours before the operation. Vital signs, heart monitoring and routine tests will be done for all patients.Laparoscopic cholecystectomy operation will be performed as 4 ports (subxiphoid, preumbilical ports with 10 mm incisions, midclavicular and anterior axillary ports with 5 mm incisions). The rate of conversion of laparoscopic surgery to open surgery, the amount of bleeding, the average duration of surgery, the amount of damage to viscera and bile ducts during the operation will be recorded. The average duration of hospitalization and the amount of bile leakage from the drain after surgery will be extracted from his file and recorded. The rate of need for repeat ERCP and the rate of infection at the surgical site after the operation will also be recorded through the follow-up of the patient's condition. After recording the extracted data and statistical analysis, the obtained results will be analyzed and written. Intervention 2: The second intervention group: late cholecystectomy - in this group, the time interval between ERCP and cholecystectomy is more than 6 days. All patients are NPO 6 hours before the operation. Vital signs, heart monitoring and routine tests will be done for all patients.Laparoscopic cholecystectomy operation will be performed as 4 ports (subxiphoid, preumbilical ports with 10 mm incisions, midclavicular and anterior axillary ports with 5 mm incisions). The rate of conversion of laparoscopic surgery to open surgery, the amount of bleeding, the average duration of surgery, the amount of damage to viscera and bile ducts during the operation will be recorded. The average duration of hospitalization and the amount of bile leakage from the drain after surgery will be extracted from his file and recorded. The rate of need for repeat ERCP and the rate of infection at the surgical site after the operation will also be recorded through the follow-up of the patient's condition. After recording the extracted data and statistical analysis, the obtained results will be analyzed and written. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after deidentifying individuals When: The access period starts after the results are printed To whom: People who are engaged in the industry can apply for them. Conditions: In all circumstances Where to obtain: Internet networks How to obtain: By search Comments:
public Hamid Talebzadeh
Hezarjerib Ave, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 Talebzadeh.h@med.mui.ac.ir Esfahan University of Medical Sciences scientific Hamid Talebzadeh
Hezarjerib Ave, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 Talebzadeh.h@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients over 18 years old with coledocolitiasis who are candidates for ERCP and then cholecystectomy 18 years no limit Both Intolerance to general anesthesia Severe liver and kidney dysfunction Patients who refuse surgery Occurrence of pancreatitis after ERCP K80.5 Calculus of bile duct without cholangitis or cholecystitis Treatment - Surgery Treatment - Surgery The first intervention group: early cholecystectomy - in this group, the time interval between ERCP and cholecystectomy is less than 6 days. All patients are NPO 6 hours before the operation. Vital signs, heart monitoring and routine tests will be done for all patients.Laparoscopic cholecystectomy operation will be performed as 4 ports (subxiphoid, preumbilical ports with 10 mm incisions, midclavicular and anterior axillary ports with 5 mm incisions). The rate of conversion of laparoscopic surgery to open surgery, the amount of bleeding, the average duration of surgery, the amount of damage to viscera and bile ducts during the operation will be recorded. The average duration of hospitalization and the amount of bile leakage from the drain after surgery will be extracted from his file and recorded. The rate of need for repeat ERCP and the rate of infection at the surgical site after the operation will also be recorded through the follow-up of the patient's condition. After recording the extracted data and statistical analysis, the obtained results will be analyzed and written. The second intervention group: late cholecystectomy - in this group, the time interval between ERCP and cholecystectomy is more than 6 days. All patients are NPO 6 hours before the operation. Vital signs, heart monitoring and routine tests will be done for all patients.Laparoscopic cholecystectomy operation will be performed as 4 ports (subxiphoid, preumbilical ports with 10 mm incisions, midclavicular and anterior axillary ports with 5 mm incisions). The rate of conversion of laparoscopic surgery to open surgery, the amount of bleeding, the average duration of surgery, the amount of damage to viscera and bile ducts during the operation will be recorded. The average duration of hospitalization and the amount of bile leakage from the drain after surgery will be extracted from his file and recorded. The rate of need for repeat ERCP and the rate of infection at the surgical site after the operation will also be recorded through the follow-up of the patient's condition. After recording the extracted data and statistical analysis, the obtained results will be analyzed and written. Local infection. Timepoint: 7 days after surgery. Method of measurement: File Reading and Physical Examination. Duration of surgery. Timepoint: During surgery. Method of measurement: File Reading. Bleeding during surgery. Timepoint: During surgery. Method of measurement: File Reading. Conversion to open surgery. Timepoint: During Surgery. Method of measurement: File reading. Bile leakage from the drain. Timepoint: one day after the surgery. Method of measurement: File Reading. Damage to internal organs and bile ducts. Timepoint: During surgery. Method of measurement: File reading. Need for repeat ERCP. Timepoint: 7 days after surgery. Method of measurement: File Reading and Physical Examination. Duration of hospitalization. Timepoint: 7 days after surgery. Method of measurement: File reading. Esfahan University of Medical Sciences Approved 2022-03-08 Ethics committee of Isfahan University of Medical Sciences Sofeh Blvd,Al-Zahra Hospital Isfahan Isfehan Iran (Islamic Republic of)