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

NCT02618564 — Not applicable, Completed, 100 participants, Queen's University

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Registry	NCT02618564
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, other
Enrollment	100 (Actual)
Sponsor	Queen's University (Other)
Conditions	Colonoscopy Preparation Outcome
Interventions	Sennosides (Drug)
Dates	start 2016-01-01, primary completion 2017-08-01, completion 2017-08-01, first posted 2015-12-01, last updated 2018-05-09
Locations	2 sites in Canada

-Summary

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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
2 TABS QHS	Active comparator	Drug: Sennosides	Sennosides 2 tabs, taken two nights before the colonoscopy
3 TABS QHS	Active comparator	Drug: Sennosides	Sennosides 3 tabs, taken two nights before the colonoscopy
2 TABS AM	Active comparator	Drug: Sennosides	Sennosides 2 tabs, taken the morning before the colonoscopy
3 TABS AM	Active comparator	Drug: Sennosides	Sennosides 3 tabs, taken the morning before the colonoscopy
2 TABS AM & QHS	Active comparator	Drug: Sennosides	Sennosides 2 tabs taken the morning before and 2 tabs taken the evening before the colonoscopy.

Sennosides (Drug), also known as Senokot: Each group will be assigned different doses of sennosides and varying times of administration

+Outcome measures

Primary outcomes

Bowel movements, as measured by patient diary [2 days]: The primary outcome of this pilot study is the number of bowel movements. Patients will record the timing and number of bowel motions produced.

Secondary outcomes

Colon cleansing, as measured by The Ottawa Scale and Aronchick Bowel Cleansing Scale [2 days]: 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
Tolerability, as measured by patient questionnaire [2 days]: The secondary outcome is patient tolerability. Patients will be asked to complete a questionnaire examining symptoms such as nausea, bloating, vomiting, and abdominal pain.

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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.

+Locations (2)

Facility	City	Country	Status
Hotel Dieu Hospital	Kingston, Ontario	Canada
Hotel Dieu Hospital	Kingston, Ontario	Canada

+Investigators

Lawrence Hookey, Principal investigator, Queen's University