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

NCT ID: NCT06724198

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-09-01

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Participants will recieve Psyllium husk twice daily for 8 weeks

Group Type: EXPERIMENTAL

Psyllium husk

Intervention Type: DIETARY_SUPPLEMENT

3.66 gram Psyllium husk twice daily for 8 weeks

Interventions

Psyllium husk

3.66 gram Psyllium husk twice daily for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Vi-Siblin, Metamucil, Fybogel

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sykehuset Telemark

OTHER_GOV

Sponsor Role: lead

Responsible Party

Silje Stensholt Holte

Principal Ivestigator Consultant Colorectal Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silje S Holte

Role: PRINCIPAL_INVESTIGATOR

Sykehuset Telemark

Locations

Sykehuset Telemark HF

Skien, Telemark, Norway

Countries

Norway

Other Identifiers

2024/732141(REK)

Identifier Type: -

Identifier Source: org_study_id