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Effect of Treatment of Low Anterior Resection Syndrome After Rectal Cancer Surgery

A Randomized Controlled Study of the Effect of Treatment of Low Anterior Resection Syndrome (LARS) After Rectal Cancer Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03215017
Enrollment
45
Registered
2017-07-12
Start date
2017-05-15
Completion date
2022-12-01
Last updated
2023-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Anterior Resection Syndrome

Brief summary

A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer. The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome.

Detailed description

A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer. The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome. An interim analysis will be made after 40 included patients in the study.

Interventions

DEVICETransanal irrigation

Effect of Transanal irrigation (TAI) using Peristeen® anal irrigation system - Coloplast

DRUGMedication

Medication to help control of the bowel movement (One or a combination of Loperamide, Sorbitol, Sterculia gum)

Sponsors

Mirna Abraham-Nordling
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients that have undergone surgery for rectal cancer (sphincter saving surgery, low anterior resection) * Adult ≥ 18 years old * Have scoring major LARS (according to the Low anterior resection syndrome score)

Exclusion criteria

* stoma * recurrent disease * Another colorectal surgery * Inflammatory bowel disease (IBD)

Design outcomes

Primary

MeasureTime frameDescription
Bowel function1 yearCleveland incontinence questionnaire
Bowel function, Low anterior resection syndrome (LARS)1 yearAssessed using LARS questionnaire (score 0-42, a high score indicates poor bowel function)

Secondary

MeasureTime frameDescription
Quality of Life (QoL)1 yearAssessed using EORTC Quality of life questionnaire (QLQ)-C30

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026