Determination of clinical manifestations observed in patients with upper gastrointestinal endoscopy (except gallstones)
Determination of improvement in gastrointestinal pain and symptoms after cholecystectomy in patients with normal upper gastrointestinal endoscopy Determination of improvement in gastrointestinal pain and symptoms after cholecystectomy in patients with abnormal upper gastrointestinal endoscopy
Design
Clinical trial without control group, with parallel groups, not blinded on 30 patients, randomization of rand function of Excel software
Settings and conduct
Study in Khatam Al-Nabiah Hospital in Shahroud and endoscopy of 30 gallstone patients 2 days before cholecystectomy and evaluation of symptoms one week, three weeks and three months after cholecystectomy
Participants/Inclusion and exclusion criteria
Admission: Age over 18 years, patients with gallstones
No admission: age under 18, unstable clinical condition, patients with acute abdomen, patients with gallbladder neoplasia
Intervention groups
Perform gastric endoscopy two days before cholecystectomy
Main outcome variables
Reduction of cholecystectomy surgery in patients with gastric lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210224050486N1
Registration date:2021-03-03, 1399/12/13
Registration timing:retrospective
Last update:2021-03-03, 1399/12/13
Update count:0
Registration date
2021-03-03, 1399/12/13
Registrant information
Name
Akam Amini
Name of organization / entity
The azad university of shahrood
Country
Iran (Islamic Republic of)
Phone
+98 44 4623 9247
Email address
lordakam095@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-11-27, 1398/09/06
Actual recruitment start date
2019-10-07, 1398/07/15
Actual recruitment end date
2020-01-06, 1398/10/16
Trial completion date
2020-05-15, 1399/02/26
Scientific title
Evaluation of the Necessity of Gastric Endoscopy Before Cholecystectomy in Patients with Gallstones
Public title
The Necessity of Gastric Endoscopy Before Cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Ultrasonographic diagnosis of symptomatic gallstones
Exclusion criteria:
Dissatisfaction with participating in the study
Age under 18 years
Patients with acute abdomen
Patients with unstable general condition
Patients with gallbladder neoplasia
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University - Shahroud Branch
Street address
Semnan , Shahroud , University Boulevard , Next to the gas station , Islamic Azad University , Central Building
City
Shahroud
Province
Semnan
Postal code
3614871151
Approval date
2021-01-13, 1399/10/24
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1399.070
Health conditions studied
1
Description of health condition studied
Gallstone ، Gastric mucosal lesions
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Findings observed in gastric endoscopy
Timepoint
Perform gastric endoscopy 2 days before cholecystectomy
Method of measurement
Gastric endoscopy device
Secondary outcomes
1
Description
Measurement of epigastric pain, heartburn, nausea, vomiting and reflux
Timepoint
The day after cholecystectomy and 7 days and 21 days and 90 days after cholecystectomy
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Intervention group: In this study, we included 30 patients who were admitted to the general surgery ward of Khatam al-Anbia Hospital in Shahroud with a diagnosis of gallstones. One or two days before gallstone surgery for all patients, upper gastrointestinal endoscopy was performed. Clinical manifestations observed in upper gastrointestinal endoscopy (gastric ulcer, GERD, gastritis, duodenal ulcer, esophagitis, duodenal inflammation) were recorded. The frequency of pathological conditions other than gallstones found by endoscopic method is considered. Based on the pathological conditions found in endoscopy or the absence of pathological conditions, patients were divided into normal and abnormal groups .Evaluation of the improvement of patients' symptoms such as epigastric pain (vas pain scale from one to ten), nausea and vomiting (yes, no), indigestion (yes, no), or reflux (yes / no). In patients in two groups with normal endoscopy and Abnormalities were performed at the following times: before surgery, one week after surgery, three weeks after surgery, three months after surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahroud , Khatam Al-Anbia Hospital
Full name of responsible person
Mehdi Naghavi
Street address
Khatam Al-Anbia Hospital, University Blvd., Tehran St.
City
Shahroud
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2661
Fax
Email
mehdinaghavimd@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Naghavi
Street address
Shahroud, Tehran St., Nader Boulevard, Unit 10
City
Shahroud
Province
Semnan
Postal code
3615653164
Phone
+98 44 4623 9247
Email
lordakam095@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Mehdi naghavi
Position
Assistant Professor , Specialist Physician, Faculty
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Semnan, Shahroud, Tehran St., University Blvd., Khatam Al-Anbia Hospital
City
Shahroud
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2661
Email
mehdinaghavi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Naghavi
Position
Assistant Professor, Faculty Physician ,Phd
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahroud, Tehran St., University Blvd., Khatam Al-Anbia Hospital
City
Shadroud
Province
Semnan
Postal code
3615871151
Phone
+98 23 3239 2661
Email
Mehdinaghavimd@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Akam Amini
Position
Entern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Buchan, Baharestan St., Soma Boulevard, No. 10
City
Boukan
Province
West Azarbaijan
Postal code
5943159591
Phone
+98 44 4623 9247
Email
Lordakam095@gmail.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
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