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

Sponsor
Tan Tock Seng Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05342116
Collaborator
(none)
300
1
3
47.8
6.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Nestle Preload
  • Other: Water
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Single (Outcomes Assessor)
Masking Description:
Endoscopists will be blinded to the patients' assigned arm.
Primary Purpose:
Prevention
Official Title:
Carbohydrate Rich Drink Reduces Pre-endoscopic Discomfort for Patients Going for Elective Endoscopic Procedures
Actual Study Start Date :
Apr 4, 2019
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Mar 30, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Fasting Arm

Patient will fast at least 6 hours prior to endoscopy

Active Comparator: Water Arm

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

Other: Water
400ml of water to be consumed 2 to 4 hours prior to the endoscopy.

Experimental: CHO Arm

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

Other: Nestle Preload
1 sachet of Preload (50g) diluted with 400ml of water, to be consumed 2 to 4 hours prior to the endoscopy.

Outcome Measures

Primary Outcome Measures

  1. Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy improves patients' overall satisfaction. [Questionnaire to be completed 30 to 60 minutes before endoscopy.]

    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

  1. Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy is safe for patients [Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.]

    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.

  2. Evaluate if Carbohydrate rich drink (CHO) pre-endoscopy affects the quality of gastric preparation [Endoscopist Questionnaire will be completed within 60 minutes post endoscopy.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tan Tock Seng Hospital Singapore Singapore 308433

Sponsors and Collaborators

  • Tan Tock Seng Hospital

Investigators

  • Study Director: Doris Ng, MBBS, Tan Tock Seng Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ng Wee Khoon, Consultant, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier:
NCT05342116
Other Study ID Numbers:
  • 2017/00872
First Posted:
Apr 22, 2022
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 22, 2022