Randomized Trial Comparing Carbonated Drink With Water as a Solvent for Colonoscopy Solution

NCT ID: NCT04316858

Last Updated: 2020-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Colonoscopy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Water

Water will be used as solvent for sodium phosphate

Group Type ACTIVE_COMPARATOR

Sodium phosphate

Intervention Type DRUG

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.

Water

Intervention Type DIETARY_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 drink

Zero calorie carbonated drink will be used as solvent for sodium phosphate

Group Type ACTIVE_COMPARATOR

Sodium phosphate

Intervention Type DRUG

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.

Zero calorie carbonated drink

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Sodium phosphate

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.

Intervention Type DRUG

Water

800 ml of water will be added to 90 ml of sodium phosphate to facilitate its intake by the patients preparatory to colonoscopy

Intervention Type DIETARY_SUPPLEMENT

Zero calorie carbonated drink

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Colonoscopy solution Diet cola

Eligibility Criteria

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Inclusion Criteria

* • Age \> 18 years

* Non-emergency / non urgent colorectal diseases (IBD, suspected colonic polyps, colorectal cancer)
* Screening Colonoscopy

Exclusion Criteria

* Age \<18 years Pregnancy Intestinal obstruction Unfit patient Acute or serious illness Coagulopathy Unwilling patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hina Noman

Senior Registrar, Surgical Unit III, Civil Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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hina noman, fcps

Role: PRINCIPAL_INVESTIGATOR

dow university and health sciences

Locations

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Dow University

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type DERIVED
PMID: 35320215 (View on PubMed)

Other Identifiers

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HNoman

Identifier Type: -

Identifier Source: org_study_id

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