Low Anterior Resection Syndrome, Quality of Life (QOL)
Conditions
Keywords
rectal cancer, LARS, quality of life, Psyllium
Brief summary
Rectal cancer constitutes 1/3 of more than 4500 annually diagnosed cases of colorectal (CRC) in Norway. With the advances in radiochemotherapy, and surgical techniques, the long-term survival rate is increasing after surgery regardless of the rising incidences, with a 73% 5-year survival rate in Norway (89% for stage I-III cancer). Low anterior resection (LAR) is the most commonly performed surgical procedure with curative intent with over 500 procedures per year in Norway alone. 80 % of patients subjected to LAR suffer from the LAR syndrome (LARS) which includes grades of bowel incontinence, urgency and tenesmus contributing to reduced quality of life (QoL). Suggested means of management have been advocated without preceding randomized trials. Psyllium husk has been suggested as a nutritional supplement for symptom reduction in patients suffering from LARS, but data is limited and no larger, randomized studies regarding its effect on patients with low anterior resection syndrome have been conducted. In this pilot study preceeding a placebo-controlled RCT, the investigators aim to improve documentation of a proposed management strategy. The investigators anticipate that a reduction in intestinal symptomburden will increase QoL for this large patientgroup.
Interventions
DIETARY_SUPPLEMENTPsyllium husk
3.66 gram Psyllium husk twice daily for 8 weeks
Sponsors
Sykehuset Telemark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, effect study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Operated with low rectal resection for rectal cancer * LARS score \>20 at 12 months or more after surgery * Written consent
Exclusion criteria
* Various conditions rendering the patient unable to answer questionnaire * LARS score 0-20 * Contraindications to Psyllium husk (hypersensitivity, intestinal obstruction, reduced esophageal function, rare congenital medical conditions such as sucrase-isomaltase deficiency, fructose intolerance and glucose-galactose malabsorbtion)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LARS score | At baseline, at 4 and 8 weeks of intervention | Low anterior resection syndrome score (0-42 points) 0-20: No LARS 21-29: Minor LARS 30-42: Major LARS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QoL) | At baseline, at 4 and 8 weeks of intervention | PROMs for self-evaluation of QoL: EQ-5D-5L VAS score (0-100 were 0 is the worst possible health and lowest quality of life and 100 is the best possible health and highest quality of life) |
Countries
Norway
Outcome results
None listed