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Completed

NCT Number: NCT04316858

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

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.

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Key information

Conditions

Colonoscopy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dow University

Karachi, Sindh, 71000, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sodium phosphate

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.

Other names: Colonoscopy solution

Water

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

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

Other names: Diet cola

Primary outcomes

  1. 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.

Secondary outcomes

  1. Degree of bowel cleanliness.

    Time frame: This will be collected at the procedure appointment which is expected to be 2-3 hours in length.

    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.

  2. 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.

    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.

  3. 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.

    This will be assessed in minutes on check-in for the colonoscopy procedure.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

A Prospective Randomized Trial in Comparison of Zero Calorie Carbonated Drink or Water as a Solvent in Sodium Phosphate for Colonoscopy

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2020
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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