The Use of Sennosides With Pico Salax in Bowel Preparation for Colonoscopy: a Study of Optimal Dose and Timing

The objective of this study is to evaluate sennosides as an adjunct to sodium picosulfate magnesium citrate (Pico Salax) in preparation for colonoscopy. We will compare different doses and administration times. The primary outcome is number of bowel motions produced. Secondary outcomes include the quality of bowel cleansing and patient tolerability.

Study Overview

• Status: Completed
• Conditions: Colonoscopy Preparation Outcome
• Intervention / Treatment: Drug: Sennosides

Detailed Description

We will compare different doses and administration times in patients booked for morning colonoscopy. The primary outcome is number of bowel motions produced in total by the sennosides. Secondary outcomes include the quality of bowel cleansing and patient tolerability.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 5G2
      • Hotel Dieu Hospital
    • Kingston, Ontario, Canada, K7L5G2
      • Hotel Dieu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and non-pregnant female patients 18 to 75 years of age inclusive
• Patients who require an outpatient colonoscopy with a split dose Pico-Salax prep

Exclusion Criteria:

• Colonoscopy requiring the use of a large volume prep (eg Colyte, PEG)
• Ileus or bowel obstruction
• Previous colorectal surgery
• Ascites
• Recognized renal impairment (defined as GFR less than normal in 3 months prior to enrolment)
• Pregnancy
• Recent (<6 months) myocardial infarction or unstable angina.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2 TABS QHS; Sennosides 2 tabs, taken two nights before the colonoscopy	Drug: Sennosides; Each group will be assigned different doses of sennosides and varying times of administration; Other Names: Senokot
Active Comparator: 3 TABS QHS; Sennosides 3 tabs, taken two nights before the colonoscopy	Drug: Sennosides; Each group will be assigned different doses of sennosides and varying times of administration; Other Names: Senokot
Active Comparator: 2 TABS AM; Sennosides 2 tabs, taken the morning before the colonoscopy	Drug: Sennosides; Each group will be assigned different doses of sennosides and varying times of administration; Other Names: Senokot
Active Comparator: 3 TABS AM; Sennosides 3 tabs, taken the morning before the colonoscopy	Drug: Sennosides; Each group will be assigned different doses of sennosides and varying times of administration; Other Names: Senokot
Active Comparator: 2 TABS AM & QHS; Sennosides 2 tabs taken the morning before and 2 tabs taken the evening before the colonoscopy.	Drug: Sennosides; Each group will be assigned different doses of sennosides and varying times of administration; Other Names: Senokot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel movements, as measured by patient diary	The primary outcome of this pilot study is the number of bowel movements. Patients will record the timing and number of bowel motions produced.	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colon cleansing, as measured by The Ottawa Scale and Aronchick Bowel Cleansing Scale	The secondary outcome is colon cleansing efficacy. The endoscopist will grade the cleansing quality of the colon using two standardized measures - the Ottawa Scale and the 5-point Aronchick Bowel Preparation Scale	2 days
Tolerability, as measured by patient questionnaire	The secondary outcome is patient tolerability. Patients will be asked to complete a questionnaire examining symptoms such as nausea, bloating, vomiting, and abdominal pain.	2 days

Collaborators and Investigators

• Sponsor: Queen's University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: October 3, 2015
• First Submitted That Met QC Criteria: November 29, 2015
• First Posted (Estimate): December 1, 2015

Study Record Updates

• Last Update Posted (Actual): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Laxatives; Sennosides
• Other Study ID Numbers: DMED#1845-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO