Clinical trial NCT04316858: Randomized Trial Comparing Carbonated Drink With Water as a Solvent for Colonoscopy Solution
Official title: A Prospective Randomized Trial in Comparison of Zero Calorie Carbonated Drink or Water as a Solvent in Sodium Phosphate for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Palatability of the solution including willingness to repeat the preparation
timeFrame: 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:
measure: Degree of bowel cleanliness.
timeFrame: This will be collected at the procedure appointment which is expected to be 2-3 hours in length.
measure: Incidence of adverse effects.
timeFrame: This will be collected at the procedure appointment which is expected to be 2-3 hours in length. It will be noted once.
measure: Completion time of preparation.
timeFrame: 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.
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University
state: Sindh
Study officials:
affiliation: dow university and health sciences
name: hina noman, fcps
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.