Clinical trial NCT00390598: PEG Solution (Laxabon®) 4L Versus Senna Glycoside (Pursennid® Ex-Lax) 36mg and PEG Solution (Laxabon®) 2L for Large Bowel Cleansing Prior to Colonoscopy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Colonoscopy
Keywords: colonoscopy
large bowel preparation
bowel cleansing
randomized controlled trial
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2006-10-20
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 criteria: 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

Primary outcomes:
measure: Efficacy of large bowel cleansing as assessed by the physician performing the colonoscopy. Two validated scoring systems are used.
Secondary outcomes:
measure: The subjective grading of patients on ease of taking the large bowel preparation treatment.
measure: Frequency of not completed large bowel preparation treatment.
measure: Frequency of abdominal symptoms due to bowel preparation treatment.
measure: Frequency of incomplete colonoscopies with insufficient view leading to a repeated colonoscopy due to low diagnostic quality at the first attempt.
measure: Costs of large bowel cleansing.
measure: Frequency of abdominal symptoms that start after onset of large bowel preparation treatment and that persists one week after the colonoscopy.
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Surgery, Umeå University Hospital
Study officials:
affiliation: Umeå University
name: Peter Naredi, MD, PhD
role: STUDY_CHAIR
affiliation: Umeå University
name: Markku M Haapamaki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hookey LC, Depew WT, Vanner SJ. Combined low volume polyethylene glycol solution plus stimulant laxatives versus standard volume polyethylene glycol solution: a prospective, randomized study of colon cleansing before colonoscopy. Can J Gastroenterol. 2006 Feb;20(2):101-5. doi: 10.1155/2006/621367.
citation: Haapamaki MM, Lindstrom M, Sandzen B. Low-volume bowel preparation is inferior to standard 4 1 polyethylene glycol. Surg Endosc. 2011 Mar;25(3):897-901. doi: 10.1007/s00464-010-1293-6. Epub 2010 Sep 2.