TARE-05-073M: PEG Solution (Laxabon®) 4L Versus Senna Glycoside (Pursennid® Ex-Lax) 36mg and PEG Solution (Laxabon®) 2L for Large Bowel Cleansing Prior to Colonoscopy

Sponsor

Umeå University (Other)

Overall Status

Completed

CT.gov ID

NCT00390598

Collaborator

(none)

490

Enrollment

Location

Arms

Duration (Months)

32.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The trial compares Laxabon® 4L versus Pursennid® Ex-Lax 36mg and 2L Laxabon® for large bowel cleansing prior to colonoscopy allocating patients planned for colonoscopy to one of the two cleansing regimens.

Condition or Disease	Intervention/Treatment	Phase
Colonoscopy	Drug: PEG (solution given 4 L) Drug: senna glycoside 36 mg and PEG (solution given 2 L)	Phase 2/Phase 3

Detailed Description

Effective large bowel cleansing prior to colonoscopy is still not achieved in all cases that undergo the procedure. The use of balanced electrolyte-polyethylene glycol (PEG) solution have improved the cleansing results and shortened the time needed for preparing the bowel. The problem with using PEG solution alone is the relatively large volume of the solution that the patients need to drink. The recommendation is to drink the solution until diarrhea fluid is clear and often 4 L or more is needed. Many patients refuse to drink the sufficient volume needed to get a clean colon. The large volume load can be a risk to patients suffering from renal and/or heart insufficiency.

Good results of bowel cleansing have also been reported with sodium phosphate solution or tablets. The fluid volume needed to drink along with sodium phosphate is generally no problem but this regimen causes electrolyte disturbances that usually are subclinical and of no significance but in patients with renal or heart insufficiency the sodium phosphate is contraindicated due to the risk of serious electrolyte disturbances.

Several combinations of stimulant laxatives with PEG solution have been tested before and the actual combination has been compared in one randomized study(1). Low-volume PEG plus sennosides preparation was better tolerated but it was not as effective as standard large-volume PEG.

PEG solution (Laxabon®) 4L is used for large bowel cleansing in many centers in Sweden and is the standard regimen used in our colonoscopy unit. In this study we compare this standard regimen with senna glycoside (Pursennid® Ex-Lax) 36mg (tablets) taken orally in the night before the colonoscopy and 2L Laxabon® solution orally starting to drink the solution four hours prior to the colonoscopy.

The result of large bowel cleansing is evaluated during the colonoscopy according to two separate validated scoring methods (Aronchick and Ottawa scores). Abdominal symptoms, discomfort, subjective grading of how hard/easy it was to complete the cleansing program and extra costs are evaluated with questionnaires.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

A Single Blind, Single Centre, Parallel Group, Randomized Controlled Trial Comparing PEG Solution (Laxabon®) 4L Versus Senna Glycoside (Pursennid® Ex-Lax) 36mg and PEG Solution (Laxabon®) 2L for Large Bowel Cleansing Prior to Colonoscopy

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: senna 36 mG + PEG 2L Bowel preparation with senna tablets 36 mG and PEG 2L prior to colonoscopy.	Drug: senna glycoside 36 mg and PEG (solution given 2 L) Other Names: Pursennid ExLax (R)= senna Laxabon (R)= PEG solution
Active Comparator: 4 L PEG Bowel preparation with 4 L PEG prior to colonoscopy.	Drug: PEG (solution given 4 L) Other Names: Laxabon (R) =PEG solution

Arm

Intervention/Treatment

Active Comparator: senna 36 mG + PEG 2L

Bowel preparation with senna tablets 36 mG and PEG 2L prior to colonoscopy.

Drug: senna glycoside 36 mg and PEG (solution given 2 L)

Other Names:

Pursennid ExLax (R)= senna

Laxabon (R)= PEG solution

Active Comparator: 4 L PEG

Bowel preparation with 4 L PEG prior to colonoscopy.

Drug: PEG (solution given 4 L)

Other Names:

Laxabon (R) =PEG solution

Outcome Measures

Primary Outcome Measures

Efficacy of large bowel cleansing as assessed by the physician performing the colonoscopy. Two validated scoring systems are used. []

Secondary Outcome Measures

The subjective grading of patients on ease of taking the large bowel preparation treatment. []
Frequency of not completed large bowel preparation treatment. []
Frequency of abdominal symptoms due to bowel preparation treatment. []
Frequency of incomplete colonoscopies with insufficient view leading to a repeated colonoscopy due to low diagnostic quality at the first attempt. []
Costs of large bowel cleansing. []
Frequency of abdominal symptoms that start after onset of large bowel preparation treatment and that persists one week after the colonoscopy. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient scheduled to undergo elective complete colonoscopy as an outpatient
Age 18 or older
The patient gives written informed consent and can understand the information given
The patient can participate only once in the study