Study on pain decrease in Patients underlying Laparoscopic Cholecystectomy
Design
Study have 2groups of Control and Trial, 48patients are going to be studied.
Block Randomization is used and ordered with Statistical Softwares.
Study is one-side blinded.
Settings and conduct
Patients with diagnosis Cholecystitis hospitalized in Ayatollah Mousavi Hospital, zanjan. will be divided in two Groups. Carbon dioxide used in Laparoscopic Cholecystectomy would have temperature differences.
Data of pain is collected with VAS scale. Study in one-side blinded.
Participants/Inclusion and exclusion criteria
Include: Patients with diagnosis of Cholecystitis candidate for Laparoscopic Cholecystectomy
Exclude: Addiction. Psychologic diseases
Intervention groups
Patients with a diagnosis of cholecystitis who are candidates for laparoscopic cholecystectomy are included in the study. Laparoscopic surgery will be performed in two groups with carbon dioxide gas at different temperatures (room temperature and 37 ° C).
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210201050196N1
Registration date:2021-02-23, 1399/12/05
Registration timing:retrospective
Last update:2021-02-23, 1399/12/05
Update count:0
Registration date
2021-02-23, 1399/12/05
Registrant information
Name
naser keikhali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3345 6006
Email address
nkeikhali@zuma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-20, 1399/09/30
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on effect of carbon dioxide temperature on prognosis of laparoscopic cholecystectomy
Public title
Carbon dioxide in Laparoscopic Cholecystectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diagnosis of cholecystectomy candidate for cholecystectomy
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Science
Street address
Ayatollah Mousavi Hospital, Zanjan
City
زنجان
Province
Zanjan
Postal code
4513956183
Approval date
2021-01-05, 1399/10/16
Ethics committee reference number
IR.ZUMS.REC.1399.358
Health conditions studied
1
Description of health condition studied
Laparoscopic Cholecystectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Carbon dioxide used in laparoscopy with room temperature
Category
Diagnosis
2
Description
Intervention group: Carbon dioxide used in laparoscopy with T= 34-38'c
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Naser keikhali
Street address
Ayatollah Mousavi Hospital, zanjan
City
zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
Mousavihospital@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Naser Keikhali
Street address
Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
Mousavihospital@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Naser Keikhali
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
۴۵۱۳۹۵۶۱۸۳
Phone
+98 24 3313 0000
Email
nkeikhali@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Naser Keikhali
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
۴۵۱۳۹۵۶۱۸۳
Phone
+98 24 3345 6006
Fax
Email
nkeikhali@zuma.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Naser Keikhali
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
۴۵۱۳۹۵۶۱۸۳
Phone
+98 24 3313 0000
Fax
Email
nkeikhali@zuma.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available