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

Not Applicable

Completed

• Conditions: Colonoscopy
• Interventions: Drug: Sodium phosphate; Dietary Supplement: Water; Dietary Supplement: Zero calorie carbonated drink

• Registration Number: NCT04316858
• Lead Sponsor: Dow University of Health Sciences

Brief 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. 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 Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-08-31
• Study Completion: 2019-12-31
• Study First Submitted: 2020-02-22
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-18
• Last Update Submitted: 2020-03-18
• Study First Posted: 2020-03-20
• Last Update Posted: 2020-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water	Sodium phosphate	Water will be used as solvent for sodium phosphate
Water	Water	Water will be used as solvent for sodium phosphate
Zero calorie carbonated drink	Sodium phosphate	Zero calorie carbonated drink will be used as solvent for sodium phosphate
Zero calorie carbonated drink	Zero calorie carbonated drink	Zero calorie carbonated drink will be used as solvent for sodium phosphate

Primary Outcome Measures

Name	Time	Method
Palatability of the solution including willingness to repeat the preparation	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 Outcome Measures

Name	Time	Method
Degree of bowel cleanliness.	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.
Incidence of adverse effects.	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.
Completion time of preparation.	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.

Trial Locations

Locations (1)

Dow University; 🇵🇰 Karachi, Sindh, Pakistan