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Completed

NCT Number: NCT00390598

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Surgery, Umeå University Hospital

Umeå, SE 90185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEG (solution given 4 L)

Drug

Other names: Laxabon (R) =PEG solution

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

Drug

Other names: Pursennid ExLax (R)= senna, Laxabon (R)= PEG solution

Primary outcomes

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

Secondary outcomes

  1. The subjective grading of patients on ease of taking the large bowel preparation treatment.

  2. Frequency of not completed large bowel preparation treatment.

  3. Frequency of abdominal symptoms due to bowel preparation treatment.

  4. Frequency of incomplete colonoscopies with insufficient view leading to a repeated colonoscopy due to low diagnostic quality at the first attempt.

  5. Costs of large bowel cleansing.

  6. Frequency of abdominal symptoms that start after onset of large bowel preparation treatment and that persists one week after the colonoscopy.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study 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

Acronym: TARE-05-073M

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 20, 2006
Registry last updated
Mar 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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