Study of the effect of decrease in carbon dioxide pressure on pain in patients with cholecystitis after laparoscopic cholecystectomy
Design
Clinical trial with control group, with parallel groups, double blind, randomized, phase 3 on 72 patients, Random allocation software was used to randomize.
Settings and conduct
Patients with a diagnosis of cholecystitis who are admitted to Ayatollah Mousavi Hospital in Zanjan are studied. In the surgical procedure, standard pressure gas(12-14mmHg) is used in one group and low pressure(8-10mmHg) in the other group. Patients will be cared for and followed up at 6-12-24 hours after surgery. Follow-up of patients by examining the amount of pain in the Visual Analog Scale(VAS) and the need for analgesics.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cholecystitis and Patient satisfaction
Exclusion criteria: Kidney disease, Liver disease, Heart disease, CNS disease, Pregnant women, Addiction, Patient dissatisfaction, History of abdominal surgery
Intervention groups
The intervention group includes patients with cholecystitis who undergo surgery with low pressure carbon dioxide(8-10mmHg) and control group includes patients with cholecystits who undergo surgery with standard pressure carbon dioxide(12-14mmHg).
Main outcome variables
Patients' pain after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210830052338N1
Registration date:2021-10-23, 1400/08/01
Registration timing:retrospective
Last update:2021-10-23, 1400/08/01
Update count:0
Registration date
2021-10-23, 1400/08/01
Registrant information
Name
Naser Keikhali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3666 4489
Email address
nkeikhali@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of decrease in carbon dioxide pressure on pain in patients with cholecystitis after laparoscopic cholecystectomy
Public title
ُStudy of the effect of decrease in carbon dioxide pressure on pain in patients with gallbladder inflammation after laparoscopy
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Cholecystitis
Patient satisfaction
Exclusion criteria:
Liver disease
Heart disease
CNS disease
Kidney disease
Pregnant women
Addiction
History of abdominal surgery
Patient dissatisfaction
Use of analgesics
Age
From 20 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
In this study at least 30 samples were calculated in each intervention and control group ( Based on the sample size formula with a type one error 5% and 80% power) which is required according to the type of randomization to 36 samples in each group. Patient randomization is done on Block Randomization basis with permutations ABAB, ABBA, AABB, BBAA, BABA, BABA. Each block is randomly selected and patients will be assigned to two groups A and B based on the permutation sequence. In Block Randomization the number of participants, 3 patients in each block, in the consecutive time intervals are entered into intervention and control groups. This study has parallel design namely any group of participants exposed to one of the study interventions. For random assignment of Random allocation software is used. These random sequencing production software in addition to simple randomization are able to generate random sequencing by blocking method.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind for participant, clinical care, researcher, impact assessor and data analyzer so that these people are not informed of carbon dioxide gas pressure and the only surgeon is notified of gas pressure.
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 Sciences
Street address
Zanjan University of Medical Sciences , Shahid Avini dormitory
City
Zanjan
Province
Zanjan
Postal code
4513956111
Approval date
2021-08-25, 1400/06/03
Ethics committee reference number
IR.ZUMS.REC.1400.211
Health conditions studied
1
Description of health condition studied
Cholecystitis
ICD-10 code
K81
ICD-10 code description
Cholecystitis
Primary outcomes
1
Description
Severity of pain
Timepoint
6 ,12 ,24 hours after the operation
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients are candidate for laparoscopic cholecystectomy surgery with low carbon dioxide gas pressure(8-10mmHg)
Category
Treatment - Surgery
2
Description
Control group: Patients are candidate for laparoscopic cholecystectomy surgery with standard carbon dioxide gas pressure(12-14mmHg)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Yalda Yusefi
Street address
Zanjan , Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3345 6006
Email
Mousavihospital@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shoghli
Street address
Zanjan University of Medical science
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6141
Email
research@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
Dr. Naser Keikhali
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 24 3314 0201
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
Dr. Naser Keikhali
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 24 3314 0201
Email
nkeikhali@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Naser Keikhali
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Zanjan University of Medical Science
City
Zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 24 3314 0201
Email
nkeikhali@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after identifying individuals.
When the data will become available and for how long
Access period starts from 2022
To whom data/document is available
The data will be available to all researchers working in academic and scientific institutions, as well as to those working in industry.
Under which criteria data/document could be used
The data will be available to start a similar clinical trail.
From where data/document is obtainable
Individuals cab refer to dr.yalda.yusefi@gmail.com to receive data.
What processes are involved for a request to access data/document
The data will be provided to the applicant at the earliest opportunity.