ColonoscopyNCT05328219
Effectiveness of Gum Chewing on Polyethylene Glycol Related Intake Adherence, GI Side Effects and Bowel Preparation
A study testing Chewing gums with PEG solution in people with Colonoscopy, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Chewing gums with PEG solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2021to 5 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who -
- Are critically ill.
- Are on anti-emetic therapy.
- Have some psychiatric issues making them unable to follow the instructions.
Trial locations and contacts
1 site in 1 country.
India1 site
Pooja Chaudhary
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: Effectiveness of Gum Chewing on Polyethylene Glycol (PEG) Related Intake Adherence, GI Side Effects and Bowel Preparation Among Patients Undergoing Colonoscopy
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
Read more
The objectives of the study are:
Primary objective
- 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
- 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.
- 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.
Read the 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
- Conditions
- Colonoscopy
- Being tested
- Chewing gums with PEG solution, Standard of care
- Keywords
- Colonoscopy, Chewing gum, Intake Adherence, Bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing gums with PEG solutionOther
Patients undergoing colonoscopy under experimental group was advised to take 2L of PEG solution and packets of sugarless sweet mint flavored chewing gums.
The patients are advised to Chew one stick of sugarless gum for at least 10 min after taking each glass of PEG solution and discard the chewing gum before taking next glass.
Standard of careOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Chewing gums with PEG solution | Experimental | The investigator provide the chewing gums with PEG solution to the experimental group. Receives: Other: Chewing gums with PEG solution |
| Standard of Care | Active comparator | Care provided as per the standard existing routine. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with complete intake of PEG solution (2 litre) in both groups
Intake Adherence among Patients Undergoing Colonoscopy was assessed by Intake Adherence tool comprises of 4 items which include time spent in ingesting the whole PEG solution in minutes, total amount of PEG solution taken, extra fluid taken other than PEG solution, total amount of fluid taken in milliliters.
Measured: up to 5 weeks
Number of patients with change in GI side effects related to PEG solution in both groups
GI side effects among Patients Undergoing Colonoscopy was assessed by Numerical Rating Scale and the Rhodes Index of Nausea, Vomiting, And Retching (INVR).
Measured: up to 5 weeks
Improvement in bowel preparation in both groups
Bowel Preparation among Patients Undergoing Colonoscopy was assessed by Boston Bowel Preparation Scale. A four-point scoring system with maximum score of 9 and minimum score of 0 applied to each of the three broad regions of the colon: the right colon (including the cecum and ascending colon), the transverse colon (including the hepatic and splenic flexures), and the left colon (including the descending colon, sigmoid colon, and rectum).
Measured: up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Nov 2021
- Primary completion14 Nov 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pooja Ms Chaudhary, Nursing, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328219
- Sponsor's protocol ID
- ILBSIndia21
- Status last verified
- Jan 2022
- First submitted
- 30 Dec 2021
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Gum Chewing on Polyethylene Glycol (PEG) Related Intake Adherence, GI Side Effects and Bowel Preparation Among Patients Undergoing Colonoscopy
- ClinicalTrials.gov ID
- NCT05328219
- Acronym / sponsor ID
- ILBSIndia21
- Conditions
- Colonoscopy
- Keywords
- Colonoscopy, Chewing gum, Intake Adherence, Bowel preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 14 Nov 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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.
- 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chewing gums with PEG solution | Experimental | Other: Chewing gums with PEG solutionThe investigator provide the chewing gums with PEG solution to the experimental group. |
| Standard of Care | Active comparator | Other: Standard of careCare provided as per the standard existing routine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- OPD Patients who -
Key exclusion criteria (4 listed)
- Patients who -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chewing gums with PEG solutionPatients undergoing colonoscopy under experimental group was advised to take 2L of PEG solution and packets of sugarless sweet mint flavored chewing gums. The patients are advised to Chew one stick of sugarless gum for at least 10 min after taking each glass of PEG solution and discard the chewing gum before taking next glass. | Other | Chewing gums with PEG solution |
| Standard of careStandard of care | Other | Standard of Care |
Primary outcome
Number of patients with complete intake of PEG solution (2 litre) in both groups
Time frame: up to 5 weeks
Intake Adherence among Patients Undergoing Colonoscopy was assessed by Intake Adherence tool comprises of 4 items which include time spent in ingesting the whole PEG solution in minutes, total amount of PEG solution taken, extra fluid taken other than PEG solution, total amount of fluid taken in milliliters.
Number of patients with change in GI side effects related to PEG solution in both groups
Time frame: up to 5 weeks
GI side effects among Patients Undergoing Colonoscopy was assessed by Numerical Rating Scale and the Rhodes Index of Nausea, Vomiting, And Retching (INVR).
Improvement in bowel preparation in both groups
Time frame: up to 5 weeks
Bowel Preparation among Patients Undergoing Colonoscopy was assessed by Boston Bowel Preparation Scale. A four-point scoring system with maximum score of 9 and minimum score of 0 applied to each of the three broad regions of the colon: the right colon (including the cecum and ascending colon), the transverse colon (including the hepatic and splenic flexures), and the left colon (including the descending colon, sigmoid colon, and rectum).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: No
Related trials for Colonoscopy
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pooja Ms Chaudhary, Nursing principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chewing gums with PEG solution in people with Colonoscopy, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with complete intake of PEG solution (2 litre) in both groups (time frame: up to 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.