Evaluation of the effect of the principles of the Modified Program of enhanced Recovery (ERAS) in ambulatory laparoscopic cholecystectomy in comparison with the traditional method and its effect on the quality of life of patients
Evaluating the effect of using ERAS principles in outpatient laparoscopic cholecystectomy outpatient surgeries in comparison with traditional methods and its effect on patients' quality of life
Design
Clinical trial with control group, parallel group, randomized 80 patients
Settings and conduct
Surgery ward of sina hospital of Tehran University of Medical Sciences during the year 1400
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. All patients (18-75) years who have accepted the consent and are candidates for elective cholecystectomy, do not have acute cholecystitis or gangrene.
2. Patients with a history of biliary colic.
3.Class 1 to 2 ASA anesthesia
4. Absence of jaundice and evidence of CBD stones
5. No kidney or liver or transplant failure
6. Absence of heart failure (EF <20%)
7. No uncontrolled blood pressure or diabetes
8. No history of upper abdominal surgery
9. No pregnancy
10. Do not use opioids or opioid antagonists in 90 days before
Exclusion criteria :)
1. Emergency surgery
2. Lack of access to the patient
3. Convert laparoscopic surgery to open surgery
4. Patient dissatisfaction with continued participation in the study
Intervention groups
The intervention group includes patients who undergo the ERAS protocol and use non-opioid analgesia to control pain, while the control group uses opioids to control pain and do not receive ERAS.
Main outcome variables
Pain control, nausea and vomiting, length of hospital stay after surgery, readmission, quality of life of patients, satisfaction and complications after surgery in the intervention group compared to the control group based on age, sex and type of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201113049373N3
Registration date:2021-11-01, 1400/08/10
Registration timing:registered_while_recruiting
Last update:2021-11-01, 1400/08/10
Update count:0
Registration date
2021-11-01, 1400/08/10
Registrant information
Name
Ehsan Rahimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4443 5556
Email address
dr.rahimpour83@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-02, 1400/07/10
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of the principles of the Modified Program of enhanced Recovery (ERAS) in ambulatory laparoscopic cholecystectomy in comparison with the traditional method and its effect on the quality of life of patients
Public title
Evaluation of the effect of the principles of the Modified Program of enhanced Recovery (ERAS) in ambulatory laparoscopic cholecystectomy in comparison with the traditional method and its effect on the quality of life of patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients (18-75) years who have accepted the consent and are candidates for elective cholecystectomy, do not have acute cholecystitis or gangrene
Patients with a history of biliary colic.
Class 1 to 2 ASA anesthesia
Absence of jaundice and evidence of CBD stones
Absence of renal or hepatic or transplant failure
Absence of heart failure (EF <20%)
No uncontrolled blood pressure or diabetes
No history of upper abdominal surgery
No pregnancy
Do not use opioids or opioid antagonists in 90 days before
Exclusion criteria:
Emergency surgery
No access to the patient
Convert laparoscopic surgery to open surgery
Patient dissatisfaction with continued participation in the study
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
اn order to randomization based on blocking of quadruple numbers used variable blocks that was easy method and equation of Groups. Samples devided to A and B that there was Six type : AABB, ABAB, ABBA, BBAA, BABA, BAAB
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Sina Hospital, 30 tir street, Imam Khomeini street
City
Tehran
Province
Tehran
Postal code
1134667911
Approval date
2021-10-01, 1400/07/09
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.794
Health conditions studied
1
Description of health condition studied
Chronic cholecystitis and symptomatic biliary colic
ICD-10 code
K81.1
ICD-10 code description
Chronic cholecystitis
Primary outcomes
1
Description
Evaluation of the effect of the principles of the Modified Program of enhanced Recovery (ERAS) in ambulatory laparoscopic cholecystectomy in comparison with the traditional method and its effect on the quality of life of patients
Timepoint
2,6,12 ,24 hours after operation-3 days and 7 days after surgery
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients candidate cholecystectomy that recevied ERAS protocol.
Category
Treatment - Surgery
2
Description
Control group: Patients did not receive ERAS protocol.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgery ward of sina hospital
Full name of responsible person
Ehsan Rahimpour
Street address
Sina Hospital, 30 tir street, Imam Khomeini street
City
Tehran
Province
Tehran
Postal code
1134667911
Phone
+98 21 6321 0000
Email
Dr.rahimpour83@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Rahimpour
Street address
Sina Hospital, 30 tir street, Imam Khomeini street
City
Tehran
Province
Tehran
Postal code
1134661179
Phone
+98 21 6321 0000
Email
Dr.rahimpour83@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Rahimpour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Sina Hospital, 30 tir street, Imam Khomeini street
City
Tehran
Province
Tehran
Postal code
1134667911
Phone
+98 21 6321 0000
Email
Dr.rahimpour83@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Rahimpour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Sina Hospital, 30 tir street, Imam Khomeini street
City
Tehran
Province
Tehran
Postal code
1134667911
Phone
+98 21 6321 0000
Email
Dr.rahimpour83@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Rahimpour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Sina Hospital, 30 tir street, Imam Khomeini street
City
Tehran
Province
Tehran
Postal code
1134667911
Phone
+98 21 6321 0000
Email
Dr.rahimpour83@yahoo.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Not all data can be shared.
When the data will become available and for how long
6 months after publication
To whom data/document is available
All people
Under which criteria data/document could be used
All analysis are possible on the data.
From where data/document is obtainable
Dr.rahimpour83@yahoo.com
09123705047
What processes are involved for a request to access data/document