The goal of this observational study is to learn why some patients develop low anterior resection syndrome (LARS) after colorectal cancer treatment. The study also aims to identify different subtypes of LARS and understand which patients may respond to specific treatments.
The main questions it aims to answer are:
* What physiological and imaging changes are associated with LARS? * How do patients with LARS differ from patients without LARS after colorectal cancer surgery? * Are there measurable differences between LARS, patients treated with organ-preserving chemoradiotherapy, and patients with fecal incontinence?
Participants will:
* Complete advanced physiological and imaging assessments related to bowel function * Be compared with four control groups:
* patients without LARS after colorectal cancer surgery * patients treated with organ-preserving chemoradiotherapy * patients with fecal incontinence and urge fecal incontinence * Take part in a single study visit where all measurements are performed
Must be able to read and understand Danish.
All participants must be adults and >18 years and have full legal capacity.
Assessed by study personnel to have understood the research protocol, being able to comply with investigation procedures as well as ability to come to the hospital at the agreed timepoints, and to complete the trial.
Patients operated for rectal cancer with a rectal resection and sphincter preserving surgery at a minimum of three months postop.
Persons that are not able to understand information
Connective tissue disorders
Parkinson's disease
Non-MRI compatible pacemaker, clips or other metal objects in the body. Patients implanted with a pacemaker for sacral nerve modulation will not undergo MRI postoperatively.
During outpatient visits, the treatment responsible doctor will identify eligible patients. Patients will be recruited at the following departments: 1. LARS patients - patient operated for rectal cancer at Department of Surgery, Aarhus University Hospital, with rectal resection with sphincter preservation and primary anastomosis. 2. Watch and wait patients - patient treated for rectal cancer with organ preservation at Aalborg University Hospital or Vejle Hospital. 3. Patients with Faecal Incontinence planned for neuromodulation at Pelvic Floor Unit, Department of Surgery, AUH.
Case-control
Prospective
Not listed
EuroQol 5-Dimension, 5-Level quality-of-life questionnaire
The EuroQol 5-Dimension, 5-Level questionnaire assesses generic health-related quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has five response levels ranging from "no problems" to "extreme problems." Score range and direction: Higher scores indicate better health-related quality of life. Includes a visual analogue scale (0-100) where higher scores indicate better self-rated health.
Low Anterior Resection Syndrome Score
The Low Anterior Resection Syndrome (LARS) Score is a disease-specific symptom questionnaire assessing bowel dysfunction after low anterior resection. It includes five items covering incontinence, frequency, clustering, urgency, and impact on daily life. Score range and direction: Total score ranges from 0 to 42. Higher scores indicate more severe bowel dysfunction. Severity categories: 0-20: No LARS 21-29: Minor LARS 30-42: Major LARS
St Mark's Incontinence score
Description: The St. Mark's Incontinence Score assesses the severity of fecal incontinence across multiple domains, including incontinence to gas, liquid, and solid stool, urgency, use of pads, and lifestyle impact. Score range and direction: Total score ranges from 0 to 24. Higher scores indicate more severe fecal incontinence.
Colostomy Impact Score
The Colostomy Impact Score is a disease-specific questionnaire evaluating the impact of living with a colostomy on daily functioning, social participation, body image, and emotional well-being. Score range and direction: Total score ranges from 0 to 100. Higher scores indicate greater negative impact of the colostomy on quality of life.
Bristol Stool Form Scale
The Bristol Stool Form Scale classifies stool consistency into seven categories ranging from hard, lumpy stools to entirely liquid stools. It is used as an indicator of bowel transit and stool form. Score range and direction: Scale ranges from Type 1 to Type 7. Lower types (1-2) indicate harder stools and slower transit. Middle types (3-4) indicate normal stool form. Higher types (6-7) indicate loose or watery stools and faster transit.
Patient Assessment of Constipation Symptoms (PAC-SYM)
The Patient Assessment of Constipation Symptoms questionnaire measures symptom severity in constipation across three domains: abdominal symptoms, stool symptoms, and rectal symptoms. Score range and direction: Each item is scored 0-4; total score ranges from 0 to 48. Higher scores indicate more severe constipation symptoms.
Click on the lead sponsor to view all of their trials.
Aalborg University Hospital
Lead sponsor
Aarhus University Hospital
Collaborator
Danish Cancer Society
Collaborator
Vejle Hospital
Collaborator
