Dataset Information

The impact of assessing and treating bile acid malabsorption on function and quality of life in patients with major Low Anterior Resection Syndrome (LARS).

ABSTRACT: Interventions: This is a prospective randomised controlled study comparing colesevelam therapy with placebo in a two-period cross-over design, where patients will act as their own controls. Radiological testing for Bile acid malabsorption (BAM) will be performed in a subset of participants prior to the intervention being administered. We aim to test at least half of the participants, but this will be determined by funding and access to radiology. We anticipate that 3-15 patients will undergo this test. Selection will be based on the test being available when the individual is recruited. The SeHCAT test involves administering 75Se 23-selena-25-homocholic acid and glycocholic acid as an oral capsule to a fasting patient. The initial count rate of 75Se will be measured three hours after the intake of the isotope. On day 7 following administration, there will be further imaging, and the net count rate of 75Se will be expressed as a percentage of the net count rate at day 0. The % retention of 75Se will be recorded. While a positive test is one that shows a retention <15%, the actual levels of 75Se will also be compared to changes in the LARS score. A 2-sequence, 2-period design will be used with a six-week washout between interventions to account for first-order carryover effects. Participants will be randomised to one of the following sequences: AB|BA, where A=colesevelam therapy and B=placebo. The intervention will be presented as 312mg capsules. The participant will start by taking two capsules (approximately 625mg) three times a day for three days, and if there are no side effects will then increase to four capsules (1.25g) three times a day. Side effects will be monitored by use of a daily patient diary and telephone interviews on days one and three. Patients will Primary outcome(s): Low Anterior Resection Syndrome (LARS) Score, from a validated questionnaire. This questionnaire will be administered in Dunedin Hospital by a research assistant before and after each treatment. [LARS score will be measured prior to commencement of the first treatment, at the end of the first 5-week treatment phase, prior to commencement of the second treatment (approximately 11 weeks post-enrollment), and at the end of the second 5-week treatment phase.];Short-form 12 Health Survey, a quality of life questionnaire. This questionnaire will be administered in Dunedin Hospital by a research assistant before and after each treatment. [Quality of life will be measured prior to commencement of the first treatment, at the end of the first 5-week treatment phase, prior to commencement of the second treatment (approximately 11 weeks post-enrollment), and at the end of the second 5-week treatment phase.];Faecal Incontinence Quality of Life Score. This will be administered at Dunedin Hospital by a research assistant.[Quality of life will be measured prior to commencement of the first treatment, at the end of the first 5-week treatment phase, prior to commencement of the second treatment (approximately 11 weeks post-enrollment), and at the end of the second 5-week treatment phase.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Safety/efficacy

DISEASE(S): Oral And Gastrointestinal-other Diseases Of The Mouth, Teeth, Oesophagus, Digestive System Including Liver And Colon,Surgery-other Surgery,Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Bile Salt Malabsorption,Low Anterior Resection,Rectal Cancer,High Anterior Resection,Ultra-low Anterior Resection

PROVIDER: 2470972 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Dataset Information

The impact of assessing and treating bile acid malabsorption on function and quality of life in patients with major Low Anterior Resection Syndrome (LARS).

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