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Low Anterior Resection SyndromePATO-LARSNCT07573371

Understanding and Tailored Treatment of Low Anterior Resection Syndrome

An observational study of Low Anterior Resection Syndrome and Faecal Incontinence With Faecal Urgency, run by Aalborg University Hospital at 3 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
145 participants
Where
3 sitesDenmark
Study dates
17 Sep 2024to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.
  • Specific inclusion criteria for LARS patients:
  • Patients operated for rectal cancer with a rectal resection and sphincter preserving surgery at a minimum of three months postop.
Show all 12Show fewer
  • If patients have received a temporary protective ileostomy, this should have been reversed for a minimum of three months postop.
  • Specific inclusion criteria for fecal incontinence patients and urge fecal incontinence patients
  • Patients planned for neuromodulation.
  • Satisfactory interoperative test results leading to permanent implantation of a pacemaker for sacral nerve modulation.
  • Specific inclusion criteria for "watch and wait" patients:
  • 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.

Who cannot join

  • General exclusion criteria
  • 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
Show all 17Show fewer
  • 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
  • Specific exclusion criterias for LARS patients
  • History of anastomotic leakage following rectal resection and sphincter preserving therapy
  • Evidens of local recurrence or dessimination of the cancer

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Esben B Mark, PhD contact

97663523 ext. +45

e.mark@rn.dk

Denmark3 sites, 2 recruiting
  • Aalborg University Hospital

    Aalborg, 9220

    Active, not recruiting
  • Aarhus University Hospital

    Aarhus, 8200

    Gitte K Sørensen, Research Nurse, 2499 5223 ext. +45, gittesoe@rm.dk

    Peter Christensen, MD, Professor

    Recruiting
  • Vejle Hospital

    Vejle, 7100

    Bettina H Ingemann, Research Nurse, 7940 9831 ext. +45, Bettina.Hugger.Ingemann@rsyd.dk

    Recruiting

Other trials in Denmark

About this study

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:

Read more
  • 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
Read the detailed description

Low anterior resection syndrome (LARS) is a common long-term complication after colorectal cancer surgery. Up to 80% of patients experience symptoms such as urgency, frequent bowel movements, clustering, and fecal incontinence. These symptoms can severely affect quality of life, and the underlying causes are not fully understood. LARS appears to result from several interacting mechanisms, including sensory changes, altered motility, reduced reservoir function, sphincter dysfunction, and effects of chemotherapy or radiotherapy. Because different patients may have different dominant mechanisms, treatment responses vary widely.

This observational study aims to investigate the physiological and imaging characteristics of LARS using advanced assessment methods. The goal is to better understand the mechanisms behind LARS, identify distinct patient subtypes, and support development of more targeted treatment strategies.

The study will include 50 patients with minor or major LARS after rectal cancer surgery. Their results will be compared with four control groups:

  • patients who had rectal cancer surgery but did not develop LARS,
  • patients with fecal incontinence (before/after sacral nerve stimulation),
  • patients with urge fecal incontinence (before/after dorsal genital nerve stimulation), and
  • patients treated with organ-preserving chemoradiotherapy ("watch-and-wait"), whose rectum has not been surgically removed.

All participants will attend a single study visit that includes advanced physiological measurements, Magnetic Resonance Imaging (MRI)-based assessments, and standardized questionnaires. These methods are not part of routine clinical care but are used to explore mechanisms such as motility, sensory function, sphincter activity, and rectal reservoir function.

Patients with LARS will also be followed during their standard stepwise treatment pathway. They will complete questionnaires before and during each treatment step, which may include dietary advice, medication, pelvic floor training (biofeedback), and rectal emptying techniques such as mini-enemas or transanal irrigation. This follow-up will help determine how different physiological patterns relate to treatment response.

The study is conducted in collaboration between Aarhus University Hospital and Aalborg University Hospital, with expert input from The Royal London Hospital (UK) and Motilis SA (Switzerland).

Keywords
LARS
Medical subject headings
Low Anterior Resection Syndrome, Encopresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07573371
Study groupRoleWhat they receive
LARS, minor or major symptomsLARS 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 symptomsLARS 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 waitRectum/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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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

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

Secondary outcomes (21)
  1. 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.

    Measured: • Applied at baseline and four weeks into all treatment periods

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. Wexner Incontinence Score

    The Wexner Incontinence Score evaluates the severity of fecal incontinence based on frequency of incontinence to gas, liquid, and solid stool, need for pads, and lifestyle alteration.

    Score range and direction:

    Total score ranges from 0 to 20. Higher scores indicate more severe fecal incontinence.

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

  6. Hospital Anxiety and Depression Scale (HADS)

    The Hospital Anxiety and Depression Scale assesses symptoms of anxiety and depression in medical populations. It consists of two subscales: HADS-Anxiety and HADS-Depression.

    Score range and direction:

    Each subscale ranges from 0 to 21. Higher scores indicate more severe symptoms of anxiety or depression. Total score (0-42) may be reported but is less commonly used.

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

  7. Whole gut and segmental transit times as measured with 3D-Transit

    Whole-gut and segmental gastrointestinal transit times are measured using the Motilis 3D-Transit system. The system tracks the movement of an electromagnetic capsule through the gastrointestinal tract, allowing calculation of segmental transit times (stomach, small intestine, colon) and total whole-gut transit time. This measure evaluates gastrointestinal motility patterns at baseline.

    Score range and direction:

    Transit times are continuous measures reported in minutes or hours.

    There is no fixed upper or lower limit, as transit times vary physiologically between individuals.

    Longer transit times indicate slower gastrointestinal motility.

    Shorter transit times indicate faster gastrointestinal motility.

    Measured: At baseline

  8. Colonic and segmental colonic volumes

    Magnetic resonance imaging is used at baseline to quantify total colonic volume and segmental colonic volumes (ascending, transverse, descending, sigmoid/rectum colon). Volumes are derived from semi-automated segmentation of the colon on T2-weighted images. This measure evaluates baseline colonic morphology and storage capacity.

    Score range and direction:

    Colonic volumes are continuous measures reported in milliliters (mL).

    There is no fixed upper or lower limit, as volumes vary physiologically between individuals.

    Higher values indicate larger colonic or segmental volume.

    Lower values indicate smaller colonic or segmental volume.

    Measured: At baseline

  9. Resting Anal Pressure Measured by High-Resolution Anorectal Manometry

    Resting anal pressure will be measured using high-resolution anorectal manometry according to standard manometric protocols. Resting anal pressure reflects basal anal sphincter tone, primarily related to internal anal sphincter function. The outcome will be reported as a continuous physiological measure in millimeters of mercury (mmHg). There are no fixed minimum or maximum values because pressures vary physiologically between individuals. Higher values indicate higher resting anal sphincter tone, while lower values indicate reduced resting sphincter tone.

    Measured: At baseline

  10. Maximal Voluntary Anal Squeeze Pressure Measured by High-Resolution Anorectal Manometry

    Maximal voluntary anal squeeze pressure will be measured using high-resolution anorectal manometry according to standard manometric protocols. Squeeze pressure reflects voluntary external anal sphincter contractile strength. The outcome will be reported as a continuous physiological measure in millimeters of mercury (mmHg). There are no fixed minimum or maximum values because pressures vary physiologically between individuals. Higher values indicate stronger voluntary anal sphincter contraction, while lower values indicate reduced voluntary sphincter contractile function.

    Measured: At baseline

  11. Rear-Front Pressure Gradient Measured by the Fecobionics Device

    The rear-front pressure gradient will be measured using the Fecobionics device during simulated stool evacuation. The Fecobionics device records axial pressure patterns during defecation. The rear-front pressure gradient reflects the pressure difference between the rear and front sensors of the device during evacuation and provides a measure of propulsive force relative to outlet resistance. The outcome will be reported as a continuous physiological measure in millimeters of mercury (mmHg). There are no fixed minimum or maximum values because values vary physiologically between individuals. Higher values indicate stronger propulsive pressure relative to outlet resistance, whereas lower values may indicate impaired propulsion or increased outlet resistance.

    Measured: At baseline

  12. Compare the physiological findings in LARS patients with controls

    Compare the physioligal findings in LARS patients with a) no-LARS patients, b) organ-preservation patients and c) patient with fecal incontinence

    Measured: At baseline

  13. Investigate the physiological changes in anorectal function associated with neuromodulation in patients with urge fecal incontinence

    Changes in anorectal function measured by the Fecobionics Device

    Measured: From baseline to after 30 minutes of active neuromodulation

  14. Investigate the physiological changes in anorectal function associated with neuromodulation in patients with urge fecal incontinence

    Changes in anorectal function measured by high-resolution anorectal manometry

    Measured: From baseline to after 30 minutes of active neuromodulation

  15. Investigate the physiological changes in anorectal function associated with neuromodulation in patients with fecal incontinence

    Changes in anorectal function measured by the Fecobionics Device

    Measured: From baseline to after active neuromodulation at Visit 2

  16. Investigate the physiological changes in anorectal function associated with neuromodulation in patients with fecal incontinence

    Changes in anorectal function measured by high-resolution anorectal manometry

    Measured: From baseline to after active neuromodulation at Visit 2

  17. Change in VAS Urgency Score From Before to During Stimulation at the Baseline Visit

    The participant's perceived urgency to defecate during the examination will be assessed using a visual analogue scale. Participants with fecal incontinence will rate their urgency to defecate on a numeric scale from 0 to 10, where 0 indicates no desire to defecate and 10 indicates maximal urgency. The outcome will be reported as the change in VAS urgency score from the pre-stimulation assessment to the stimulation assessment at the baseline visit. Higher scores indicate stronger urgency to defecate.

    Measured: Baseline visit: immediately before stimulation and during active stimulation

  18. Resting-State Electroencephalography

    Resting-state electroencephalography is recorded with the participant at rest to assess baseline cortical activity patterns. Measures include spectral power across standard frequency bands (theta, alpha, beta).

    Score range and direction:

    Spectral power values are continuous and do not have fixed upper limits.

    Higher or lower values reflect differences in cortical activity depending on frequency band.

    Measured: At baseline

  19. Evoked Potential Amplitude During Rectal Balloon Distension

    Electroencephalography is recorded during rapid rectal balloon distension to elicit cortical evoked potentials. The primary measure is the amplitude of the evoked response to visceral stimulation.

    Score range and direction:

    Amplitude is measured in microvolts (µV).

    Higher amplitudes indicate stronger cortical responses to visceral stimulation.

    Measured: At baseline

  20. Evoked Potential Latency During Rectal Balloon Distension

    Electroencephalography is recorded during rectal balloon distension to measure the latency of cortical evoked potentials, reflecting the timing of sensory pathway activation.

    Score range and direction:

    Latency is measured in milliseconds (ms).

    Longer latencies indicate slower or delayed cortical processing.

    Shorter latencies indicate faster neural conduction.

    Measured: At baseline

  21. Defecation Index Measured by the Fecobionics Device

    The defecation index will be derived from Fecobionics measurements obtained during simulated stool evacuation. The index summarizes expulsion performance and anorectal function based on prespecified Fecobionics-derived variables. The outcome will be reported as a continuous index value. There are no fixed minimum or maximum values. Higher values indicate more efficient expulsion and better defecatory performance, whereas lower values indicate reduced defecatory performance.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2026
  2. Study start17 Sep 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
145 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07573371
Sponsor's protocol ID
R325-A19027
Acronym
PATO-LARS
Status last verified
May 2026
First submitted
20 Apr 2026
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because the study involves sensitive health information and data protection regulations (GDPR) prevent public sharing of identifiable or de-identified participant-level data.

Questions about this trial

What is this clinical trial studying?

An observational study of Low Anterior Resection Syndrome and Faecal Incontinence With Faecal Urgency, run by Aalborg University Hospital at 3 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Esben B Mark, PhD (97663523 ext. +45, e.mark@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EuroQol 5-Dimension, 5-Level quality-of-life questionnaire (time frame: From baseline visit to the end of each standardized treatments at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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