NCT04316858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

February 22, 2020

Last Update Submit

March 18, 2020

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Palatability of the solution including willingness to repeat the preparation

    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.

    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 (3)

  • Degree of bowel cleanliness.

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

  • 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.

  • 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.

Study Arms (2)

Water

ACTIVE COMPARATOR

Water will be used as solvent for sodium phosphate

Drug: Sodium phosphateDietary Supplement: Water

Zero calorie carbonated drink

ACTIVE COMPARATOR

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

Drug: Sodium phosphateDietary Supplement: Zero calorie carbonated drink

Interventions

Sodium phosphateDRUG

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.

Also known as: Colonoscopy solution
WaterZero calorie carbonated drink
WaterDIETARY_SUPPLEMENT

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

Water
Zero calorie carbonated drinkDIETARY_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

Also known as: Diet cola
Zero calorie carbonated drink

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Non-emergency / non urgent colorectal diseases (IBD, suspected colonic polyps, colorectal cancer)
  • Screening Colonoscopy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dow University

Karachi, Sindh, 71000, Pakistan

Location

Related Publications (1)

  • 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.

    PMID: 35320215DERIVED

MeSH Terms

Interventions

sodium phosphateWater

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • hina noman, fcps

    dow university and health sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Registrar, Surgical Unit III, Civil Hospital

Study Record Dates

First Submitted

February 22, 2020

First Posted

March 20, 2020

Study Start

March 1, 2019

Primary Completion

August 31, 2019

Study Completion

December 31, 2019

Last Updated

March 20, 2020

Record last verified: 2020-03

Locations

PA(1)