Clinical trial NCT05328219: Effectiveness of Gum Chewing on Polyethylene Glycol Related Intake Adherence, GI Side Effects and Bowel Preparation
Official title: Effectiveness of Gum Chewing on Polyethylene Glycol (PEG) Related Intake Adherence, GI Side Effects and Bowel Preparation Among Patients Undergoing Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Keywords: Colonoscopy
Chewing gum
Intake Adherence
Bowel preparation
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Problem statement An Experimental Study to assess the effectiveness of Gum Chewing on Polyethylene Glycol (PEG) Related Intake Adherence, GI Side Effects and Bowel Preparation among Patients Undergoing Colonoscopy at ILBS, New Delhi.

Objectives of the study

The objectives of the study are:

Primary objective

1. To compare the effect of gum chewing in experimental vs. control groups in terms of PEG Related Intake Adherence, GI side effects and Bowel Preparation among Patients Undergoing Colonoscopy.

Secondary objective

1. To find the relationship of total amount of fluid taken with GI side effects and Bowel Preparation variables in patients undergoing colonoscopy under experimental group.
2. To determine the association of PEG Related Intake Adherence, GI side effects and Bowel Preparation among Patients with socio-demographic and clinical variables in patients undergoing colonoscopy under experimental group.

Detailed description: Aim of the study To evaluate the effectiveness of Gum Chewing on Polyethylene Glycol (PEG) Related Intake Adherence, GI Side Effects and Bowel Preparation among Patients Undergoing Colonoscopy at ILBS, New Delhi.

Operational Definitions

Assess:

In this study, Assess refers to evaluating the effectiveness of Gum Chewing on Polyethylene Glycol (PEG) Related Intake Adherence, GI Side Effects and Bowel Preparation among Patients Undergoing Colonoscopy at ILBS, New Delhi.

Effectiveness:

In this study, effectiveness refers to degree to which gum chewing is successful in improving the intake adherence, GI side effects and bowel preparation from taking PEG solution among patients undergoing colonoscopy in experimental group as compared with the control group.

Chewing gum:

In this study, commercially available sugar free chewing gum was used, these were made with a delicious sweet mint flavour for a clean and fresh feeling and chewing gum with the PEG solution was taken as per the evidenced based protocol.

Ingredients: Sorbitol, Gum Base, Glycerol, Natural and Artificial Flavors; Less than 2% of: Hydrogenated Starch Hydrolysate, Aspartame, Mannitol, Acesulfame K, Soy Lecithin, Xylitol, Colors (Blue 1 Lake, Beta-Carotene), BHT (To Maintain Freshness).

GI Side Effects:

In this study, GI side effects refers to occurrence of gastro intestinal symptoms including abdominal discomfort, nausea, vomiting and retching secondary to the intake of PEG solution for bowel preparation in patients undergoing colonoscopy.

Abdominal discomfort:

In this study, abdominal discomfort refers to the sense of bowel movement and abdominal pain caused by intake of polyethylene glycol solution assessed by Numerical Rating Scale.

Nausea, Vomiting and Retching:

In this study, Nausea was defined as the desire to vomit without indulging in expulsive muscular movements. Vomiting was defined as the oral expulsion of gastrointestinal contents, while retching was the attempt to vomit without expelling any material. All these three parameters was assessed by using Rhodes index of nausea, vomiting and retching.

Intake Adherence:

In this study, it refers to the degree to which the patients undergoing colonoscopy follows the instructions related to PEG solution intake for bowel preparation. It was measured in terms of the total amount of PEG solution ingested, the total time taken for ingestion, extra fluid taken and total fluid taken before the colonoscopy.

Bowel Preparation:

In this study, bowel preparation refers to the extent to which the colon was cleared off the fecal matter following PEG solution ingestion in the patient undergoing colonoscopy. It was assessed by the colonoscopist using BBPS.

Polyethylene glycol solution:

In this study, PEG solution was given for bowel preparation for patients undergoing colonoscopy as prescribed by doctors. It was available in form of packet i.e., to be dissolved in 2 L of water. Patient was instructed to ingest whole solution within 2 hours as per the ingestion protocol.

Patient:

In this study, patient refers to the individual who was advised for colonoscopy for therapeutic or diagnostic purpose during the data collection period at OPDs of ILBS.

Colonoscopy:

In this study, colonoscopy refers to the elective procedure done to examine the colon for diagnostic and/or therapeutic purposes of various diseases like colorectal cancer, intestinal obstruction, GI bleeding etc.

Development and Description of Tools

Tools were prepared on an extensive review of books, journals, articles, Guide and Expert's opinion and investigators personal experience.

For the selection and preparation of tools, the following steps were taken:

* Planning for required tools.
* An extensive review of tools used in various literatures was undertaken.
* Discussion with Guides, Peer group and Professionals.
* A formal observation in the concerned area of the study.
* Requirement of the tools according to objectives and the conceptual framework were sought.
* Opinion of 9 Experts was sought to determine the clarity, relevance, representativeness, comprehensiveness, ambiguity and simplicity of the tools.

Thus the most appropriate tools were used in the present study. These tools were majorly divided into six sections as follows:

Structured Questionnaires Section I: Subject Data Sheet which further consist of

* Section A- Socio-Demographic Variables
* Section B- Clinical Variables Section II: Intake adherence Standardized Tools Section III: Numerical Rating Scale Section IV: The Rhodes Index of Nausea, Vomiting and Retching (INVR). Section V: Boston Bowel Preparation Scale. Structured Tools Section VI: Record Sheets
* Patient's Log Book

Eligibility criteria: Inclusion Criteria:

* OPD Patients who -

  * Have been planned for elective colonoscopy for therapeutic and/or diagnostic purposes.
  * Have been prescribed PEG solution for bowel preparation.
  * Are able to chew gum.
  * Are willing to participate in the study.
  * Can read and write English or Hindi.

Exclusion Criteria:

* Patients who -

  * Are critically ill.
  * Are on anti-emetic therapy.
  * Have some psychiatric issues making them unable to follow the instructions.

Primary outcomes:
measure: Number of patients with complete intake of PEG solution (2 litre) in both groups
timeFrame: up to 5 weeks
measure: Number of patients with change in GI side effects related to PEG solution in both groups
timeFrame: up to 5 weeks
measure: Improvement in bowel preparation in both groups
timeFrame: up to 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Pooja Chaudhary
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Pooja Ms Chaudhary, Nursing
role: PRINCIPAL_INVESTIGATOR
References: