Understanding and Tailored Treatment of Low Anterior Resection Syndrome

NCT07573371 | Recruiting

• 1 other identifier: R325-A19027
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Low Anterior Resection Syndrome; Faecal Incontinence With Faecal Urgency; Faecal Incontinence; Colorectal (Colon or Rectal) Cancer Survivors

Keywords

LARS

Outcome Measures

Primary Outcomes (2)

• 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.

  From baseline visit to the end of each standardized treatments at 4 weeks

• 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

  From baseline visit to the end of each standardized treatments at 4 weeks

Secondary Outcomes (21)

• St Mark's Incontinence score

  • Applied at baseline and four weeks into all treatment periods

• Colostomy Impact Score

  From baseline visit to the end of each standardized treatments at 4 weeks

• Bristol Stool Form Scale

  From baseline visit to the end of each standardized treatments at 4 weeks

• Patient Assessment of Constipation Symptoms (PAC-SYM)

  From baseline visit to the end of each standardized treatments at 4 weeks

• Wexner Incontinence Score

  From baseline visit to the end of each standardized treatments at 4 weeks

Study Arms (5)

LARS, minor or major symptoms

LARS score ≥ 20; Patients operated for rectal cancer with a rectal resection and sphincter preserving surgery at a minimum of three months postoperative. If patients have received a temporary protective ileostomy, this should have been reversed for a minimum of three months postoperative.

LARS, no symptoms

LARS score \< 20; Patients operated for rectal cancer with a rectal resection and sphincter preserving surgery at a minimum of three months postoperative. If patients have received a temporary protective ileostomy, this should have been reversed for a minimum of three months postoperative.

Faecal Incontinence

* Patients planned for neuromodulation * Satisfactory interoperative test results leading to permanent implantation of a pacemaker for sacral nerve modulation

Faecal Incontinence, urge

* Patients planned for neuromodulation * Satisfactory interoperative test results leading to permanent implantation of a pacemaker for sacral nerve modulation * Faecal urgency occurring ≥3 episodes per week, with or without associated Faecal incontinence (≥1 episode per week), and a St. Mark's Incontinence Score of ≥9

Watch and wait

Rectum/colon cancer patients treated with organ-preserving treatment, i.e., chemotherapy and radiotherapy with a complete clinical and radiological response at a minimum of 12 months posttreatment

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• General:
• 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.
• If patients have received a temporary protective ileostomy, this should have been reversed for a minimum of three months postop.
• Patients planned for neuromodulation.
• Satisfactory interoperative test results leading to permanent implantation of a pacemaker for sacral nerve modulation.
• Rectum/colon cancer patients treated with organ-preserving treatment, i.e., chemotherapy and radiotherapy with a complete clinical and radiological response at a minimum of 12 months posttreatment.

You may not qualify if:

• 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.
• Piercings that cannot be removed before MRI
• Claustrophobia
• Allergic to latex
• Abdominal diameter equal or more than 140 cm
• Have other individual factors, in the opinion of the physician/healthcare professional, in which participating is contraindicated
• Participation in concomitant clinical trial
• Known intestinal obstruction, significant intestinal strictures or perforation. If in doubt about intestinal stricture, the patient will be examined with MRI of the small intestine, colonoscopy or other supplementing examination
• Disorders of swallowing
• Pregnant women
• History of anastomotic leakage following rectal resection and sphincter preserving therapy
• Evidens of local recurrence or dessimination of the cancer

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aarhus University Hospital: collaborator
• Danish Cancer Society: collaborator
• Vejle Hospital: collaborator

Study Sites (3)

Aalborg University Hospital

Aalborg, 9220, Denmark

ACTIVE NOT RECRUITING

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Vejle Hospital

Vejle, 7100, Denmark

RECRUITING

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Encopresis

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Peter Christensen, MD, Professor

  Pelvic Floor Unit, Department of Surgery, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esben B Mark, PhD

CONTACT

97663523; e.mark@rn.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 7, 2026
• Study Start: September 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)