| CTRI Number |
CTRI/2023/07/054855 [Registered on: 06/07/2023] Trial Registered Prospectively |
| Last Modified On: |
05/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
MEASUREMENT OF STOMACH VOLUME iN PATIENTS WITH LIVER RELATED DISEASES KEPT STARVING BEFORE OPERATION USING SONOGRAPHY MACHINE . |
|
Scientific Title of Study
|
ULTRASOUND ASSESSMENT OF GASTRIC VOLUME IN FASTED PATIENTS WITH HEPATOBILIARY DISEASE PRIOR TO ELECTIVE SURGERY -A PROSPECTIVE OBSERVATIONAL SINGLE COHORT STUDY. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JYOTI SURYAWANSHI |
| Designation |
JUNIOR RESIDENT OF MD ANAESTHESIOLOGY |
| Affiliation |
LTMMC GH SION MUMBAI |
| Address |
DEPT OF ANEASTHESIOLOGY,
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE GENERAL HOSPITAL SION DR BABASAHEB AMBEDKAR ROAD MUMBAI 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9881780589 |
| Fax |
|
| Email |
suryawanshijyoti17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR APARNA NERURKAR |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
LTMMC & GH SION MUMBAI 400022 |
| Address |
DEPT OF ANEASTHESIOLOGY
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE GENERAL HOSPITAL SION DR BABASAHEB AMBEDKAR ROAD MUMBAI 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9833944243 |
| Fax |
|
| Email |
draparnanerurkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR APARNA NERURKAR |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
LTMMC & GH SION MUMBAI 400022 |
| Address |
DEPT OF ANEASTHESIOLOGY
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE GENERAL HOSPITAL SION DR BABASAHEB AMBEDKAR ROAD MUMBAI 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9833944243 |
| Fax |
|
| Email |
draparnanerurkar@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
LTMMC & GH SION,MUMBAI |
| Address |
LTMMC & GH SION,MUMBAI
DR.BABASAHEB AMBEDKAR RAOD SION(WEST),MUMBAI 400022 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR JYOTI SURYAWANSHI |
GENERAL SURGERY OPERATION THREATERS OF LTMMC &GH SION MUMBAI 400022. |
THIRD FLOOR,WARD BUILIDING,GENERAL SURGERY OT
LTMMC &GH SION MUMBAI400022
Mumbai
MAHARASHTRA |
9881780589
suryawanshijyoti17@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K819||Cholecystitis, unspecified, (2) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere, (3) ICD-10 Condition: K80||Cholelithiasis, (4) ICD-10 Condition: K82||Other diseases of gallbladder, (5) ICD-10 Condition: K83||Other diseases of biliary tract, (6) ICD-10 Condition: K74||Fibrosis and cirrhosis of liver, (7) ICD-10 Condition: K76||Other diseases of liver, |
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Intervention / Comparator Agent
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1)PATIENTS WITH HEPATOBILIARY DISEASE AGED MORE THAN 18 YEARS POSTED FOR ELECTIVE SURGERY.
2) PATIENTS GIVING CONSENTS FOR PERFORMING GASTRIC ULTRASOUND. |
|
| ExclusionCriteria |
| Details |
1)PREGNANT WOMEN,DIABETES MELITIS PATIENTS,OBESE PATIENTS BMI>25.
2)PATIENTS WITH ESOPHGEAL OR STOMACH PATHOLOGY LIKE ACHALSIA CARDIA,HIATUS HERNIA,CA ESOPHAGUS .
3)PATIENTS WHO HAS UNDERGONE GASTRECTOMY,GASTRIC BYPASS SURGERY.
4)PATIENTS WHO ARE UNABLE TO TURN OR LIE DOWN IN RIGHT LATERAL POSITION.
5)PATIENTS ON DRUG SUCH AS PROKINETIC METOCLOPRAMIDE,DOMPERIDONE.
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Method of Generating Random Sequence
|
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Method of Concealment
|
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Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
| DETERMINE THE CORRELATION, IF ANY, BETWEEN FASTING TIME AND ULTRASONOGRAPHICALLY CALCULATED GASTRIC VOLUME IN HEPATOBILIARY DISEASE PATIENTS PRESENTING TO ELECTIVE SURGERY. |
USG ASSESSMENT IN IMMEDIATE PREOPERATIVE PERIOD |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| TO FIND OUT THE INCIDENCE OF DELAYED GASTRIC EMPTYING IN HEPATOBILIARY DISEASE PATIENTS. |
USG ASSESSMENT IN IMMEDIATE PREOPRATIVE PERIOD
MORE THAN 6 HRS FROM LAST MEAL |
|
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Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="4" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
There is increased chance of aspiration after general anesthesia due to suppression of upper airway protective reflexes and lower esophageal sphincter tone.1,2 Perioperative aspiration can lead to serious complications such as aspiration pneumonia. Thus patients scheduled to undergo elective surgery are asked to undergo preoperative fasting to prevent pulmonary aspiration1,3 . Patients with chronic liver disease 5 , cirrhosis4 , portal hypertension6 exhibit delayed gastric emptying because of autonomic dysfunction, impairment of certain gastrointestinal peptides such as motilin, cholecytokinin and glucagons that produce metabolic abnormalities in patients with chronic hepatobiliary disease. Patients with gall bladder disease exhibit delayed gastric emptying because of various mechanisms such as no hormonal stimuli from diseased gall bladder mucosa to mediate gastric motility and reflex pyloroduodenal ileus resulting from inflammation in and around the gall bladder14 . Ultrasonography is an emerging diagnostic tool for evaluating type and volume of gastric content8,10. Bedside gastric ultrasound may be an informative and potentially important tool for risk assessment and safe anesthetic management. Hence we decided to find correlation between hours of preoperative fasting time and gastric volume in patients with hepatobiliary disease by using gastric ultrasound |