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

NCT06724198 | Active Not Recruiting

• 1 other identifier: 2024/732141(REK)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Anterior Resection Syndrome; Quality of Life (QOL)

Keywords

rectal cancer, LARS, quality of life, Psyllium

Outcome Measures

Primary Outcomes (1)

• LARS score

  Low anterior resection syndrome score (0-42 points) 0-20: No LARS 21-29: Minor LARS 30-42: Major LARS

  At baseline, at 4 and 8 weeks of intervention

Secondary Outcomes (1)

• Quality of Life (QoL)

  At baseline, at 4 and 8 weeks of intervention

Study Arms (1)

Intervention group

EXPERIMENTAL

Participants will recieve Psyllium husk twice daily for 8 weeks

Dietary Supplement: Psyllium husk

Interventions

Psyllium husk DIETARY_SUPPLEMENT

3.66 gram Psyllium husk twice daily for 8 weeks

Also known as: Vi-Siblin, Metamucil, Fybogel

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Operated with low rectal resection for rectal cancer
• LARS score \>20 at 12 months or more after surgery
• Written consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sykehuset Telemark: lead

Study Sites (1)

Sykehuset Telemark HF

Skien, Telemark, 3710, Norway

Location

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Rectal Neoplasms

Interventions

Psyllium; Vi-siblin; citric acid, ispaghula husk, sodium bicarbonate drug combination

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Silje S Holte

  Sykehuset Telemark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Ivestigator Consultant Colorectal Surgeon

Model Details: Open-label, effect study

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 9, 2024
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After study completion
• Access Criteria: Collaborators

Locations

NO (1)