PEG Solution (Laxabon®) 4L Versus Senna Glycoside (Pursennid® Ex-Lax) 36mg and PEG Solution (Laxabon®) 2L for Large Bowel Cleansing Prior to Colonoscopy (TARE-05-073M)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colonoscopy |
Drug: PEG (solution given 4 L) Drug: senna glycoside 36 mg and PEG (solution given 2 L) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind 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 |
- Efficacy of large bowel cleansing as assessed by the physician performing the colonoscopy. Two validated scoring systems are used.
- 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.
| Estimated Enrollment: | 490 |
| Study Start Date: | September 2005 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
Active Comparator: 4 L PEG
Bowel preparation with 4 L PEG prior to colonoscopy.
|
Drug: PEG (solution given 4 L)
Other Name: Laxabon (R) =PEG solution
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Exclusion Criteria:
- Earlier resection of the large bowel or rectum
- Active known colitis
- Ileus or gastro-intestinal obstruction
Contacts and Locations| Sweden | |
| Department of Surgery, Umeå University Hospital | |
| Umeå, Sweden, SE 90185 | |
| Study Chair: | Peter Naredi, MD, PhD | Umeå University |
| Principal Investigator: | Markku M Haapamaki, MD, PhD | Umeå University |
More Information
Publications:
| Responsible Party: | Markku Haapamäki, Umea University |
| ClinicalTrials.gov Identifier: | NCT00390598 History of Changes |
| Other Study ID Numbers: | TARE-05-073M |
| Study First Received: | October 19, 2006 |
| Last Updated: | March 23, 2011 |
| Health Authority: | Sweden: The National Board of Health and Welfare |
Keywords provided by Umeå University:
|
colonoscopy large bowel preparation bowel cleansing randomized controlled trial |
Additional relevant MeSH terms:
|
Cardiac Glycosides Senna Extract Sennoside A&B Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Cardiotonic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Cathartics Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013