| CTRI Number |
CTRI/2024/11/076263 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Usage of ultrasonography to assess stomach volume before surgery in gynaecological cancer patients |
|
Scientific Title of Study
|
Bed side ultrasound to estimate and compare gastric volumes in patients of gynaecological malignancies with other non-gastrointestinal, non-pelvic malignancies: A Prospective Observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SARIN P JOHN |
| Designation |
DM ONCOANAESTHESIA |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
| Address |
42, room- 3A, Himanshu goel building, Arjun nagar, Safdarjung enclave, Delhi
DR BRA IRCH AIIMS Campus Ansari Nagar East New delhi
DELHI
110029
INDIA
New Delhi
DELHI
110029
India |
| Phone |
8838851512 |
| Fax |
|
| Email |
sarinpjohn3419@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SAURABH VIG |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
| Address |
DR BRA IRCH AIIMS Campus Ansari Nagar East New delhi
DELHI
110029
INDIA
New Delhi
DELHI
110029
India |
| Phone |
9538247725 |
| Fax |
|
| Email |
saurabh377@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
SARIN P JOHN |
| Designation |
DM ONCOANAESTHESIA |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
| Address |
42, Room no-3A, Himanshu goel building, Arjun nagar, Safdarjung enclave, Delhi
DR BRA IRCH AIIMS Campus Ansari Nagar East New delhi
DELHI
110029
INDIA
New Delhi
DELHI
110029
India |
| Phone |
8838851512 |
| Fax |
|
| Email |
sarinpjohn3419@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BRA IRCH Aiims New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Saurabh Vig |
| Address |
Associate Professor, department of oncoanaesthesia and palliative medicine, national cancer institute (NCI-Aiims), Aiims delhi, delhi |
| Type of Sponsor |
Other [Thesis Guide] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SARIN P JOHN |
AIIMS Delhi |
Surgical oncology department, Irch building, surgical oncology ward first floor and fifth floor
New Delhi
DELHI |
8838851512
sarinpjohn3419@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Observational study |
| Comparator Agent |
Nil |
Observational study |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
ASA Status 1-3, BMI 20-40kg/m2, undergoing elective gynaecological surgery for adnexal/pelvic mass with or without ascites under general anaesthesia, having followed institutional fasting guidelines |
|
| ExclusionCriteria |
| Details |
Refusal to participate, history of gastric or oesophageal malignancy, any condition associated with gastroparesis, BMI more than 40, ASA 4, those who are not able to lie still or in right lateral decubitus position for ultrasound assessment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Antral cross sectional area using bed side ultrasonography in fasted patients of gynaecological malignancies after following ERAS based fasting guidelines |
after 6 hours of overnight fasting |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Antral cross sectional area using ultrasonography post ingestion of maltodextrin drink |
5 minute post ingestion to 2 hours post ingestion |
| Rate of clearance of maltodextrin between groups |
2 hours |
| Blood sugar level before ingestion and 2 hours after ingestion of maltodextrin |
2 hours |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
Final Enrollment numbers achieved (Total)= "128"
Final Enrollment numbers achieved (India)="128" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2024 |
| Date of Study Completion (India) |
24/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - on request mail to contact faculty
- For how long will this data be available start date provided 01-09-2026 and end date provided 01-09-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Full stomach is a well known factor for aspiration in the perioperative period and the development of postoperative pulmonary complications. Little is known about pathophysiology of gastric emptying in adnexal mass. There are case reports and literature suggesting that patients with adnexal mass wil present with non-specific gastric symptoms and gastric fullness. In the existing literature, evidence to support or reject the hypothesis of patients wth abdominopelvic masses having delayed Gastric emptying is available only in the form of case reports.to the best of our efforts, we could not find any prospective study comparing the fasting gastric volumes in patients with gynaecologicak malignancies with the general population |