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

Sponsor
Dow University of Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04316858
Collaborator
(none)
2
Enrollment
1
Location
2
Arms
10
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sodium phosphate
  • Dietary Supplement: Water
  • Dietary Supplement: Zero calorie carbonated drink
 N/A

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

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Other
Official Title:
A Prospective Randomized Trial in Comparison of Zero Calorie Carbonated Drink or Water as a Solvent in Sodium Phosphate for Colonoscopy
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Aug 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Water

Water will be used as solvent for sodium phosphate

Drug: 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.
Other Names:
  • Colonoscopy solution

    • Dietary Supplement: Water
    800 ml of water will be added to 90 ml of sodium phosphate to facilitate its intake by the patients preparatory to colonoscopy
    Active Comparator: Zero calorie carbonated drink

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

    Drug: 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.
    Other Names:
  • Colonoscopy solution

    • 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
    Other Names:
  • Diet cola

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dow University Karachi Sindh Pakistan 71000

    Sponsors and Collaborators

    • Dow University of Health Sciences

    Investigators

    • Principal Investigator: hina noman, fcps, dow university and health sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hina Noman, Senior Registrar, Surgical Unit III, Civil Hospital, Dow University of Health Sciences
    ClinicalTrials.gov Identifier:
    NCT04316858
    Other Study ID Numbers:
    • HNoman
    First Posted:
    Mar 20, 2020
    Last Update Posted:
    Mar 20, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 20, 2020