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IRCT20170316033099N10 IRCT 2019-10-31 Kerman University of Medical Sciences Abdominal pain after gallbladder removal A clinical trial comparing the severity of abdominal pain after gallbladder removal from umbilical and subxiphoid ports in patients with symptomatic gallstone 2017-06-22 anticipated 76 Complete https://irct.ir/trial/43217 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: After the patients were recruited, they were assigned a code. Using the table of random numbers, the researcher allocated them to intervention group one or two, Blinding description: The study aim and procedure were explained to the patients. However, it remained untold as to which port to be used for the removal of their gallbladder. Patients and those who collected the data were blinded to the gallbladder removal port. 2 Symptomatic gallstone. Intervention 1: Intervention group 1 (subxiphoid port): after the patient underwent general anesthesia, the gallbladder was removed from the subxiphoid port. Intervention 2: Intervention group 2 (umbilical port): after the patient underwent general anesthesia, the gallbladder was removed from the umbilical port. Yes - There is a plan to make this available What will be shared: Deidentified Individual Participant Data Set When: when the article extracted from the research project is published and for 6 months To whom: researchers Conditions: research purposes Where to obtain: personal correspondence with the corresponding author How to obtain: Email to the corresponding author Comments:
public Dr Ali Afsharizadeh
Imam Khomeini Highway
Kerman Iran (Islamic Republic of) 7616913911 +98 34 3132 8000 m.mofidi92@yahoo.com Kerman University of Medical Sciences scientific Dr Ali Afsharizadeh
Imam Khomeini Highway
Kerman Iran (Islamic Republic of) 7619813159 +98 34 4234 0301 m.mofidi92@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Age between 20 and 60 years Presence of symptomatic gallstone Elective laparoscopic cholecystectomy surgery conducted in Afzalipour Care Center of Kerman Informed consent for participation in the study 20 years 60 years Both Patients taking psychotropic drugs, including hypnotic and sedative drugs for any reason Epilepsy patients treated with antiepileptic therapy Patients who received pain relief for any reason Patients who had postoperative surgical complications, including wound bleeding and infection Acute cholecystitis patients whose pain initiated 72 hours earlier and did not respond well to medical treatment, thereby undergoing laparoscopic cholecystectomy K80 Cholelithiasis Treatment - Surgery Treatment - Surgery Intervention group 1 (subxiphoid port): after the patient underwent general anesthesia, the gallbladder was removed from the subxiphoid port. Intervention group 2 (umbilical port): after the patient underwent general anesthesia, the gallbladder was removed from the umbilical port. Postoperative abdominal pain severity. Timepoint: 6 hours, 24 hours and 2 weeks after surgery. Method of measurement: Visual Analogue Scale. Kerman University of Medical Sciences Approved 2017-06-12 Research Ethics Committee of Kerman University of Medical Sciences Haft Bagh Alavi Ave. Kerman Kerman Iran (Islamic Republic of)