Bowel Dysfunction After Low Rectal Resection. an Pilot Study Using Psyllium Husk in Rectal Cancer Patients.

Not Applicable

Recruiting

• Conditions: Low Anterior Resection Syndrome; Quality of Life (QOL)

• Registration Number: NCT06724198
• Lead Sponsor: Sykehuset Telemark

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-27
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-07-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Sykehuset Telemark HF; 🇳🇴 Skien, Telemark, Norway