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Carbohydrate Rich Drink Reduces Pre-endoscopic Discomfort for Patients Going for Elective Endoscopic Procedures

Primary Purpose

Hunger, Depression, Anxiety

Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Nestle Preload
Water
Sponsored by
Tan Tock Seng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hunger

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Planned for elective gastroscopy.
  • Able to communicate to give informed consent and complete the questionnaire
  • 21 to 80 year old
  • ASA physical status I-II

Exclusion Criteria:

  • Medications that might impair gastrointestinal motility
  • Conditions that may impair gastrointestinal motility, gastroesophageal reflux, pregnancy
  • Potential for difficult airway management.
  • Diabetic patients.
  • American Society of Anesthesiology (ASA) physical status III or more
  • Unable to communicate to give informed consent or complete the questionnaire

Sites / Locations

  • Tan Tock Seng Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Fasting Arm

Water Arm

CHO Arm

Arm Description

Patient will fast at least 6 hours prior to endoscopy

Patient will drink 400 ml of water 2 to 4 hours prior to endoscopy

Patient will drink 400 ml of Preload 2 to 4 hours prior to endoscopy

Outcomes

Primary Outcome Measures

Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy improves patients' overall satisfaction.
To evaluate if Carbohydrate rich drink pre-endoscopy helps to reduce discomfort experienced by patients during fasting, with lesser thirst, hunger, pain and anxiety, resulting in better overall satisfaction for endoscopic procedures. Participants will be asked to complete a Satisfaction Questionnaire prior to the endoscopy.

Secondary Outcome Measures

Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy is safe for patients
Most endoscopy centres require patients to fast for 6 to 8 hours prior to endoscopy (fasting arm) or may allow clear fluids up till 2 hours prior to endoscopy (water arm). We aim to evaluate if Carbohydrate rich drink (CHO) has the same safety profile (in terms of risk of aspiration pneumonia and patient discomfort), compared to the conventional fasting arm and water arm. Endoscopist performing the gastroscopy will complete an Endoscopist Questionnaire, which will record if there were any periprocedural complications.
Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy affects the quality of gastric preparation
Most endoscopy centres require patients to fast for 6 to 8 hours prior to endoscopy (fasting arm) or may allow clear fluids up till 2 hours prior to endoscopy (water arm). We aim to evaluate if Carbohydrate rich drink (CHO) affects the quality of gastric preparation (in terms of good endoscopic views during gastroscopy), compared to the conventional fasting arm and water arm. Endoscopist performing the gastroscopy will complete an Endoscopist Questionnaire, which will record if there were good endoscopic views during the gastroscopy.

Full Information

First Posted
April 11, 2022
Last Updated
April 18, 2022
Sponsor
Tan Tock Seng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05342116
Brief Title
Carbohydrate Rich Drink Reduces Pre-endoscopic Discomfort for Patients Going for Elective Endoscopic Procedures
Official Title
Carbohydrate Rich Drink Reduces Pre-endoscopic Discomfort for Patients Going for Elective Endoscopic Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 4, 2019 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tan Tock Seng Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is a randomised controlled trial that aims to evaluate whether carbohydrate loading pre-endoscopy can improve patients' overall satisfaction and is not associated with negative impact on endoscopic quality or increased complications. A questionnaire will be completed by participants prior to endoscopy.
Detailed Description
Currently, the evidence of usage of CHO is mainly for pre-operative patients and has never been evaluated for use in patients before endoscopic procedures which would also require them to fast substantially. Using the same principles of perioperative care, the aim of this a pilot study is to evaluate if Preload usage prior to endoscopic procedures will minimise patient discomfort secondary to fasting with alleviation of preprocedural thirst, hunger and anxiety symptoms. As a result, it may also reduce the urge for patients to drink and ingest prior to endoscopy, which may translate to last minute cancellation of procedures and wastage of precious resources. We believe it will improve overall patient experience and compliance to preprocedural fasting, without significant risks for patients or affecting the quality of endoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hunger, Depression, Anxiety, Vomiting, Abdominal Pain, Thirst, Fatigue, Lethargy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomised controlled trial with 3 arms: (1) Fasting 6 hours prior to endoscopy, (2) Allow up to 400ml of water up to 2 hours before endoscopy, (3) Carbohydrate loading with Preload 400ml at least 2-4 hours before endoscopy.
Masking
Outcomes Assessor
Masking Description
Endoscopists will be blinded to the patients' assigned arm.
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fasting Arm
Arm Type
No Intervention
Arm Description
Patient will fast at least 6 hours prior to endoscopy
Arm Title
Water Arm
Arm Type
Active Comparator
Arm Description
Patient will drink 400 ml of water 2 to 4 hours prior to endoscopy
Arm Title
CHO Arm
Arm Type
Experimental
Arm Description
Patient will drink 400 ml of Preload 2 to 4 hours prior to endoscopy
Intervention Type
Other
Intervention Name(s)
Nestle Preload
Intervention Description
1 sachet of Preload (50g) diluted with 400ml of water, to be consumed 2 to 4 hours prior to the endoscopy.
Intervention Type
Other
Intervention Name(s)
Water
Intervention Description
400ml of water to be consumed 2 to 4 hours prior to the endoscopy.
Primary Outcome Measure Information:
Title
Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy improves patients' overall satisfaction.
Description
To evaluate if Carbohydrate rich drink pre-endoscopy helps to reduce discomfort experienced by patients during fasting, with lesser thirst, hunger, pain and anxiety, resulting in better overall satisfaction for endoscopic procedures. Participants will be asked to complete a Satisfaction Questionnaire prior to the endoscopy.
Time Frame
Questionnaire to be completed 30 to 60 minutes before endoscopy.
Secondary Outcome Measure Information:
Title
Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy is safe for patients
Description
Most endoscopy centres require patients to fast for 6 to 8 hours prior to endoscopy (fasting arm) or may allow clear fluids up till 2 hours prior to endoscopy (water arm). We aim to evaluate if Carbohydrate rich drink (CHO) has the same safety profile (in terms of risk of aspiration pneumonia and patient discomfort), compared to the conventional fasting arm and water arm. Endoscopist performing the gastroscopy will complete an Endoscopist Questionnaire, which will record if there were any periprocedural complications.
Time Frame
Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.
Title
Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy affects the quality of gastric preparation
Description
Most endoscopy centres require patients to fast for 6 to 8 hours prior to endoscopy (fasting arm) or may allow clear fluids up till 2 hours prior to endoscopy (water arm). We aim to evaluate if Carbohydrate rich drink (CHO) affects the quality of gastric preparation (in terms of good endoscopic views during gastroscopy), compared to the conventional fasting arm and water arm. Endoscopist performing the gastroscopy will complete an Endoscopist Questionnaire, which will record if there were good endoscopic views during the gastroscopy.
Time Frame
Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Planned for elective gastroscopy. Able to communicate to give informed consent and complete the questionnaire 21 to 80 year old ASA physical status I-II Exclusion Criteria: Medications that might impair gastrointestinal motility Conditions that may impair gastrointestinal motility, gastroesophageal reflux, pregnancy Potential for difficult airway management. Diabetic patients. American Society of Anesthesiology (ASA) physical status III or more Unable to communicate to give informed consent or complete the questionnaire
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris Ng, MBBS
Organizational Affiliation
Tan Tock Seng Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
With the initial pilot study results, we intend to expand it to other endoscopic procedures.
Citations:
PubMed Identifier
21242424
Citation
Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J; Enhanced Recovery After Surgery Study Group. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011 May;146(5):571-7. doi: 10.1001/archsurg.2010.309. Epub 2011 Jan 17.
Results Reference
background
PubMed Identifier
11682427
Citation
Hausel J, Nygren J, Lagerkranser M, Hellstrom PM, Hammarqvist F, Almstrom C, Lindh A, Thorell A, Ljungqvist O. A carbohydrate-rich drink reduces preoperative discomfort in elective surgery patients. Anesth Analg. 2001 Nov;93(5):1344-50. doi: 10.1097/00000539-200111000-00063.
Results Reference
background
PubMed Identifier
28045707
Citation
Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
Results Reference
background
PubMed Identifier
14584013
Citation
Brady M, Kinn S, Stuart P. Preoperative fasting for adults to prevent perioperative complications. Cochrane Database Syst Rev. 2003;(4):CD004423. doi: 10.1002/14651858.CD004423.
Results Reference
background
PubMed Identifier
8526579
Citation
Nygren J, Thorell A, Jacobsson H, Larsson S, Schnell PO, Hylen L, Ljungqvist O. Preoperative gastric emptying. Effects of anxiety and oral carbohydrate administration. Ann Surg. 1995 Dec;222(6):728-34. doi: 10.1097/00000658-199512000-00006.
Results Reference
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Carbohydrate Rich Drink Reduces Pre-endoscopic Discomfort for Patients Going for Elective Endoscopic Procedures

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