ColonoscopyNCT04316858
Randomized Trial Comparing Carbonated Drink With Water as a Solvent for Colonoscopy Solution
A study testing Sodium phosphate, Water and Zero calorie carbonated drink in people with Colonoscopy, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
This prospective randomized trial will be conducted in all patients undergoing elective colonoscopies from February 2020 to August 2020 in Dowites Operation Theater Endoscopy suite by surgical unit III, Civil Hospital Karachi. Patient will be select randomly based on inclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Sodium phosphate, Water and Zero calorie carbonated drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2019to 31 Dec 2019
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Age > 18 years
- Non-emergency / non urgent colorectal diseases (IBD, suspected colonic polyps, colorectal cancer)
- Screening Colonoscopy
Who cannot join
- Age <18 years Pregnancy Intestinal obstruction Unfit patient Acute or serious illness Coagulopathy Unwilling patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Trial in Comparison of Zero Calorie Carbonated Drink or Water as a Solvent in Sodium Phosphate for Colonoscopy
This prospective randomized trial will be conducted in all patients undergoing elective colonoscopies from February 2020 to August 2020 in Dowites Operation Theater Endoscopy suite by surgical unit III, Civil Hospital Karachi. Patient will be select randomly based on inclusion criteria. Patients will be advised to take 90ml of sodium phosphate in 800ml solvent ( zero calorie soft drink and water). Patients will be nil per oral from midnight aside from clear liquids. Serum electrolytes, urea, creatinine will be measured after and before bowel preparation. Bowel preparation will be assessed by consultant during endoscopy. Questionnaire will be filled by PI for palatability, tolerance of solution, adverse effects, and willingness to repeat the preparation.
Read the detailed description
This prospective randomized trial will be conducted in all patients undergoing elective colonoscopies from February 2020 to August 2020 in Dowites Operation Theater Endoscopy suite by surgical unit III, Civil Hospital Karachi. Patient will be select randomly based on inclusion criteria. Patients will be advised to take 90ml of sodium phosphate in 800ml solvent ( zero calorie soft drink and water). Patients will be nil per oral from midnight aside from clear liquids. Serum electrolytes, urea, creatinine will be measured after and before bowel preparation. Bowel preparation will be assessed by consultant during endoscopy. Questionnaire will be filled by PI for palatability, tolerance of solution, adverse effects, and willingness to repeat the preparation.
90ml of sodium phosphate will be added to 800ml of solvent and taken in divided doses one day prior to procedure. Whole solution will be finished 3 -4 hours before colonoscopy. The instructions about how to take the solution will be clearly explained at the time of booking. Complete Blood Count and hepatitis B and C screening as routine shall be done. All procedure will be carried out under monitored sedation by trained colorectal surgeon from the faculty
- Conditions
- Colonoscopy
- Being tested
- Sodium phosphate, Water, Zero calorie carbonated drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium phosphateDrug
Also called Colonoscopy solution
90ml of sodium phosphate will be added to 800ml of solvent( water or zero calorie carbonated drink) and taken in divided doses one day prior to procedure. Whole solution will be finished 3 -4 hours before colonoscopy.
WaterDietary supplement
800 ml of water will be added to 90 ml of sodium phosphate to facilitate its intake by the patients preparatory to colonoscopy
Zero calorie carbonated drinkDietary supplement
Also called Diet cola
800 ml of zero calorie diet cola will be added to 90 ml of sodium phosphate to facilitate its intake by the patients preparatory to colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Water | Active comparator | Water will be used as solvent for sodium phosphate Receives: Drug: Sodium phosphate; Dietary Supplement: Water |
| Zero calorie carbonated drink | Active comparator | Zero calorie carbonated drink will be used as solvent for sodium phosphate Receives: Drug: Sodium phosphate; Dietary Supplement: Zero calorie carbonated drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palatability of the solution including willingness to repeat the preparation
This will be assessed by a questionnaire to be filled by the patient on check-in for the colonoscopy procedure. It will be scored on a scale of 1 to 4 as excellent, good, satisfactory or bad; score 1 being excellent result.
Measured: This will be collected at the procedure appointment which is expected to be 2-3 hours in length. This time will be labelled as time 0 and will be noted once. T
Secondary outcomes (3)
Degree of bowel cleanliness.
This will be assessed by a questionnaire to be filled by the endoscopist after completion of endoscopy. It will assessed on a scale of 1 to 4 as excellent, satisfactory, poor or bad, with score 1 being the excellent.
Measured: This will be collected at the procedure appointment which is expected to be 2-3 hours in length.
Incidence of adverse effects.
This will be assessed by the reporting of adverse effects by the patients and laboratory evaluation of electrolytes prior to and after bowel preparation. These will be noted on a proforma and following side effects will be noted: Nausea/vomiting, bloating, cramps, or electrolyte abnormalities.
Measured: This will be collected at the procedure appointment which is expected to be 2-3 hours in length. It will be noted once.
Completion time of preparation.
This will be assessed in minutes on check-in for the colonoscopy procedure.
Measured: This will be assessed only once on check-in for the colonoscopy procedure.This will be collected at the procedure appointment which is expected to be 2-3 hours in length.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start1 Mar 2019
- Primary completion31 Aug 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hina Noman, Dow University of Health Sciences
- Investigators
- hina noman, fcps, Principal investigator, dow university and health sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316858
- Sponsor's protocol ID
- HNoman
- Status last verified
- Mar 2020
- First submitted
- 22 Feb 2020
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khan H, Memon AS, Abbasi MR, Samo KA, Agha JM, Rathore L, Saeed S. A prospective randomized trial to compare the effectiveness of zero calorie carbonated drink and water as a solvent in sodium phosphate for colonoscopy. J Pak Med Assoc. 2022 Mar;72(3):409-412. doi: 10.47391/JPMA.2344.
PubMed 35320215
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial in Comparison of Zero Calorie Carbonated Drink or Water as a Solvent in Sodium Phosphate for Colonoscopy
- ClinicalTrials.gov ID
- NCT04316858
- Acronym / sponsor ID
- HNoman
- Conditions
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Mar 2020 (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.
This prospective randomized trial will be conducted in all patients undergoing elective colonoscopies from February 2020 to August 2020 in Dowites Operation Theater Endoscopy suite by surgical unit III, Civil Hospital Karachi. Patient will be select randomly based on inclusion criteria. Patients will be advised to take 90ml of sodium phosphate in 800ml solvent ( zero calorie soft drink and water). Patients will be nil per oral from midnight aside from clear liquids. Serum electrolytes, urea, creatinine will be measured after and before bowel preparation. Bowel preparation will be assessed by consultant during endoscopy. Questionnaire will be filled by PI for palatability, tolerance of solution, adverse effects, and willingness to repeat the preparation.
Detailed description
This prospective randomized trial will be conducted in all patients undergoing elective colonoscopies from February 2020 to August 2020 in Dowites Operation Theater Endoscopy suite by surgical unit III, Civil Hospital Karachi. Patient will be select randomly based on inclusion criteria. Patients will be advised to take 90ml of sodium phosphate in 800ml solvent ( zero calorie soft drink and water). Patients will be nil per oral from midnight aside from clear liquids. Serum electrolytes, urea, creatinine will be measured after and before bowel preparation. Bowel preparation will be assessed by consultant during endoscopy. Questionnaire will be filled by PI for palatability, tolerance of solution, adverse effects, and willingness to repeat the preparation.
90ml of sodium phosphate will be added to 800ml of solvent and taken in divided doses one day prior to procedure. Whole solution will be finished 3 -4 hours before colonoscopy. The instructions about how to take the solution will be clearly explained at the time of booking. Complete Blood Count and hepatitis B and C screening as routine shall be done. All procedure will be carried out under monitored sedation by trained colorectal surgeon from the faculty
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water | Active comparator | Drug: Sodium phosphate, Dietary Supplement: WaterWater will be used as solvent for sodium phosphate |
| Zero calorie carbonated drink | Active comparator | Drug: Sodium phosphate, Dietary Supplement: Zero calorie carbonated drinkZero calorie carbonated drink will be used as solvent for sodium phosphate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Age > 18 years
Key exclusion criteria (1 listed)
- Age <18 years Pregnancy Intestinal obstruction Unfit patient Acute or serious illness Coagulopathy Unwilling patients
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 |
|---|---|---|
| Sodium phosphateAlso: Colonoscopy solution90ml of sodium phosphate will be added to 800ml of solvent( water or zero calorie carbonated drink) and taken in divided doses one day prior to procedure. Whole solution will be finished 3 -4 hours before colonoscopy. | Drug | Water, Zero calorie carbonated drink |
| Water800 ml of water will be added to 90 ml of sodium phosphate to facilitate its intake by the patients preparatory to colonoscopy | Dietary supplement | Water |
| Zero calorie carbonated drinkAlso: Diet cola800 ml of zero calorie diet cola will be added to 90 ml of sodium phosphate to facilitate its intake by the patients preparatory to colonoscopy | Dietary supplement | Zero calorie carbonated drink |
Primary outcome
Palatability of the solution including willingness to repeat the preparation
Time frame: This will be collected at the procedure appointment which is expected to be 2-3 hours in length. This time will be labelled as time 0 and will be noted once. T
This will be assessed by a questionnaire to be filled by the patient on check-in for the colonoscopy procedure. It will be scored on a scale of 1 to 4 as excellent, good, satisfactory or bad; score 1 being excellent result.
3 secondary outcomes
Degree of bowel cleanliness.
Time frame: This will be collected at the procedure appointment which is expected to be 2-3 hours in length.
Incidence of adverse effects.
Time frame: This will be collected at the procedure appointment which is expected to be 2-3 hours in length. It will be noted once.
Completion time of preparation.
Time frame: This will be assessed only once on check-in for the colonoscopy procedure.This will be collected at the procedure appointment which is expected to be 2-3 hours in length.
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 20 Mar 2020.
- Derived from this study: PubMed 35320215Khan H, Memon AS, Abbasi MR, Samo KA, Agha JM, Rathore L, Saeed S. A prospective randomized trial to compare the effectiveness of zero calorie carbonated drink and water as a solvent in sodium phosphate for colonoscopy. J Pak Med Assoc. 2022 Mar;72(3):409-412. doi: 10.47391/JPMA.2344.
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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.
hina noman, fcps principal investigator
dow university and health sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium phosphate, Water and Zero calorie carbonated drink in people with Colonoscopy, run by Dow University of Health Sciences at 1 site in Pakistan.
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 3 inclusion and 1 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 20 Mar 2020. 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 Pakistan. 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?
Palatability of the solution including willingness to repeat the preparation (time frame: This will be collected at the procedure appointment which is expected to be 2-3 hours in length. This time will be labelled as time 0 and will be noted once. T). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04316858, which also lists 1 linked publication.
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 20 Mar 2020; AzTrials last refreshed its copy on 3 Nov 2026.