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OpenTrials
Completed

NCT Number: NCT06724198

Bowel Dysfunction After Low Rectal Resection. An Pilot Study Using Psyllium Husk In Rectal Cancer Patients.

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Psyllium husk

Dietary Supplement

3.66 gram Psyllium husk twice daily for 8 weeks

Other names: Vi-Siblin, Metamucil, Fybogel

Primary outcomes

  1. LARS score

    Time frame: 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 outcomes

  1. Quality of Life (QoL)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Sykehuset Telemark

Other Gov

Registry information

Official study title

Quality of Life (QoL) and Symptom Burden After Low Rectal Resection. An Open, Effect Pilot Study With Psyllium Husk Treatment in Rectal Cancer Patients.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
May 11, 2026

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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