| CTRI Number |
CTRI/2025/07/090627 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Is a shorter fast before endoscopy just as good as overnight fasting for patients requiring elective endoscopy in visualising the stomach lining during the endoscopy procedure? |
|
Scientific Title of Study
|
Comparison of conventional overnight fasting with abbreviated fasting protocol regarding the mucosal visibility in patients undergoing esophagogastroduodenoscopy: a non-inferiority, randomised controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KAUSIKI MISHRA |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Blackwell 2, Hostel Complex, JIPMER, Puducherry, Pondicherry 605001
Pondicherry
PONDICHERRY
605001
India |
| Phone |
9933220398 |
| Fax |
|
| Email |
mishrakausiki@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Reddy Abhinaya P |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
No. 4, Muthuvazhi Mariamman Koil St. Pakkamudayanpet, Lawspet, Puducherry. Pin:
Pondicherry
PONDICHERRY
605008
India |
| Phone |
04132962633 |
| Fax |
|
| Email |
reddy.kmc2k6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reddy Abhinaya P |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
No. 4, Muthuvazhi Mariamman Koil St. Pakkamudayanpet, Lawspet, Puducherry. Pin:
Pondicherry
PONDICHERRY
605008
India |
| Phone |
04132962633 |
| Fax |
|
| Email |
reddy.kmc2k6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawharlal Institiute of postgraduate medical education and research (JIPMER), Puducherry. |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
Not applicable |
| Type of Sponsor |
Government medical college |
|
|
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 ABHINAYA REDDY P |
JIPMER |
DHANVANTRI NAGAR, PUDUCHERRY, PONDICHERRY, 605006
Pondicherry
PONDICHERRY |
8195014433
reddy.kmc2k6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Interventional Studies, JIPMER, Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K254||Chronic or unspecified gastric ulcer with hemorrhage, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Nil per oral after midnight.
Water up to 300 ml allowed until 10 AM (2 hours before EGD).
No solid foods or prokinetic medications.
EGD will be performed between 10 AM to 12 PM.
|
| Intervention |
Intervention Group |
Nil per oral after midnight.
Light breakfast (two idlis) 4 hours before the EGD (approximately 8 AM).
Participants will also receive Metoclopramide 10 mg (to accelerate gastric emptying) at the same time as breakfast (8 AM).
300 mL of water is allowed until 10 AM (2 hours before EGD).
EGD will be performed after four hours of light breakfast (at 12 PM).
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants aged between 18 to 70 years.
2. Participants planned for elective, unsedated EGD.
3. Participants scheduled for EGD between 10 AM to 12 PM.
|
|
| ExclusionCriteria |
| Details |
1. Patients with suspected or known case of GI obstruction.
2. Already receiving prokinetic medications.
3. Known diabetic patients.
4. Patients scheduled for emergency or therapeutic EGD.
5. Pregnant or lactating females.
6. History of upper GI surgery.
7. Participants with known sensitivity or intolerance to metoclopramide.
8. Participants on antiepileptic drugs or medication for extrapyramidal disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| In patients undergoing elective esophagogastroudonoscopy, following conventional overnight fasting protocol and abbreviated fasting protocol, to evaluate and compare mucosal visibility during elective EGD, using the Total Visibility Score. |
In patients undergoing elective esophagogastroudonoscopy, following conventional overnight fasting protocol and abbreviated fasting protocol, to evaluate and compare mucosal visibility during elective EGD, using the Total Visibility Score. Which will be assessed during the procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| a. The comfort of the patient, before and during EGD, will be assessed using the Visual Analogue Scale (VAS). |
before and after the procedure |
| b. The incidence of adverse events such as nausea, vomiting, aspiration, or hypoglycemia. |
Before and after the procedure |
| c. The percentage of patients requiring repeat EGD. |
after the procedure |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/07/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomised controlled trial investigates whether an abbreviated fasting protocol, including a light breakfast and water allowed closer to procedure time, is noninferior to the conventional overnight fasting protocol in terms of gastric mucosal visibility during unsedated esophagogastroduodenoscopy (EGD). Study Design Participants: Outpatients scheduled for elective EGD Randomisation Using the SNOSE technique into two groups: control and intervention Control Group Nil per oral after midnight, only water up to 300 mL allowed until 8 AM, EGD between 10 and 12 PM Intervention Group: Light breakfast, two idlis plus an optional side dish at 8 AM, metoclopramide at 6 AM water up to 300 mL until 10 AM, EGD at 12 PM EGD Procedure Performed without sedation by experienced endoscopists Mucosal visibility assessed in four gastric segments using a standardised 4-point scoring system The total visibility score TVS ranges from 4 to 16. Less than 7 is acceptable visibility; seven or more is insufficient visibility. Other Assessments Patient comfort will be measured using the Visual Analogue Scale VAS before and after EGD. Procedure duration and adverse events are monitored post-EGD and up to one week after |