NCT03787888

Brief Summary

Colonoscopy is a useful tool used in modern medicine and it is increasingly being employed for both diagnostic and therapeutic purposes. (Polyethelene glycol)PEG is very often used for bowel preparation.There are some cases of hyponatremia reported due to the use of PEG. This study was designed to find frequency of sodium disorders after bowel cleansing by Polyethylene glycol solution for colonoscopies in Dr. Ruth K.M. Pfau, Civil Hospital Karachi.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

December 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
2 months until next milestone

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
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

August 18, 2021

Status Verified

December 1, 2018

Enrollment Period

6 months

First QC Date

December 15, 2018

Last Update Submit

August 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frequency of hyponatremia caused by polyethelene glycol.

    Frequency of hyponatremia caused by polyethelene glycol when used as a bowel cleansing agent for colonoscopy.

    12 hours

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing colonoscopy at OT complex Dr. K.M. Pfau, Civil Hospital Karachi.

You may qualify if:

  • Patients of either gender of age between 18-80 years undergoing colonoscopy.
  • Patients should have normal electrolytes before taking solution.
  • Patients should have given informed consent.
  • Patients should have taken solution adequately before procedure.

You may not qualify if:

  • Patients with chronic kidney disease
  • Patients on diuretics
  • Patients who are hyponatremic on first sample, i.e., before taking bowel cleansing agent.
  • Hypothyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruth KM Pauf Civil Hospital

Karachi, Sindh, 74000, Pakistan

Location

Related Publications (2)

  • ASGE Technology Committee; Mamula P, Adler DG, Conway JD, Diehl DL, Farraye FA, Kantsevoy SV, Kaul V, Kethu SR, Kwon RS, Rodriguez SA, Tierney WM. Colonoscopy preparation. Gastrointest Endosc. 2009 Jun;69(7):1201-9. doi: 10.1016/j.gie.2009.01.035. No abstract available.

    PMID: 19481646BACKGROUND
  • Samad N, Fraser I. Severe symptomatic hyponatremia associated with the use of polyethylene glycol-based bowel preparation. Endocrinol Diabetes Metab Case Rep. 2017 Feb 23;2017:16-0119. doi: 10.1530/EDM-16-0119. eCollection 2017.

    PMID: 28458891BACKGROUND

MeSH Terms

Conditions

Hyponatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Haris Alvi, FCPS

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 15, 2018

First Posted

December 26, 2018

Study Start

March 1, 2019

Primary Completion

August 31, 2019

Study Completion

September 30, 2019

Last Updated

August 18, 2021

Record last verified: 2018-12

Locations