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IRCT20210201050196N1 IRCT 2021-02-23 Zanjan University of Medical Sciences Carbon dioxide in Laparoscopic Cholecystectomy Study on effect of carbon dioxide temperature on prognosis of laparoscopic cholecystectomy 2020-12-20 anticipated 48 Complete https://irct.ir/trial/54025 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: A randomized block is used to randomize the patients under study and to fully observe the randomness of placement in the control group and the sample group, because the inclusion process requires randomization due to the ongoing recruitment. Based on the calculated sample size, the sample size in each group is 24 people for easier application of random blocks to randomize the members of each group. Permutations are considered as 6 permutations according to 2 groups: AABB, ABAB, BBAA, BABA, BAAB, ABBA. The permutations are written on 6 cards and the selection of permutations and their order will be randomly selected from among the cards. The order of exit of the cards is written and will determine the order of recruitment of intervention groups based on it. An individual randomization unit will be used for the study. The information of the registered persons will be anonymous and without their personal information, Blinding description: This study is based on one-side blinded methods. Meaning Patients would not be aware of their groups. Only Surgeon knows patients belong to which groups. in addition, the student who collects the data is not aware of patients and their groups too. 2-3 Laparoscopic Cholecystectomy. Intervention 1: Control group: Carbon dioxide used in laparoscopy with room temperature. Intervention 2: Intervention group: Carbon dioxide used in laparoscopy with T= 34-38'c. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more Available data
public Naser Keikhali
Ayatollah Mousavi Hospital
Zanjan Iran (Islamic Republic of) ۴۵۱۳۹۵۶۱۸۳ +98 24 3313 0000 nkeikhali@zums.ac.ir Zanjan University of Medical Sciences scientific Naser Keikhali
Mousavi Hospital
Zanjan Iran (Islamic Republic of) ۴۵۱۳۹۵۶۱۸۳ +98 24 3345 6006 nkeikhali@zuma.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Patients with diagnosis of cholecystectomy candidate for cholecystectomy 18 years no limit Both Exposure to unpredictable consequences unrelated to the surgical technique during surgery Need to convert laparoscopic surgery to laparotomy surgery Notice significant adhesion around the gallbladder before surgery Diagnosis Diagnosis Control group: Carbon dioxide used in laparoscopy with room temperature Intervention group: Carbon dioxide used in laparoscopy with T= 34-38'c Post surgery pain of patients undergoing Laparoscopic Cholecystectomy. Timepoint: Post surgery pain in patients would studied in 6,12,24 hours after surgery. Method of measurement: Based on VAS scale, data would be collected. Zanjan University of Medical Sciences Approved 2021-01-05 Ethics committee of Zanjan University of Medical Science Ayatollah Mousavi Hospital, Zanjan زنجان Zanjan Iran (Islamic Republic of)