Rectal CancerTreatableNCT06914245
Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients_contributing Factors (Treatable)
A study testing Electronic bowel diary, Faecal Incontinence Quality of Life questionnaire (FIQL) and EuroQoL 5 dimensions, 5 levels (EQ-5D-5L) in people with Rectal Cancer and LARS - Low Anterior Resection Syndrome, run by KU Leuven at 1 site in Belgium.
Trial summary
Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection combined with chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, LARS - Low Anterior Resection Syndrome, Active Surveillance
- What is being tested?
- Electronic bowel diary, Faecal Incontinence Quality of Life questionnaire (FIQL) and EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Apr 2025to Dec 2028
- Phase
- Interventional
- 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
Who may be able to join
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- At least 18 years of age at the time of signing the Informed Consent Form (ICF).
- Proficient in reading, comprehending, and conversing in Dutch.
- Patients scheduled for Total Mesorectal Excision (TME) or Partial Mesorectal Excision (PME) or 'Watch and wait' protocol due to rectal cancer.
Who cannot join
- The participant has undergone a different type of surgery, including a Hartmann procedure, abdominoperineal excision, transanal endoscopic microsurgery, or sigmoid resection.
- Experienced fecal incontinence prior to undergoing surgery.
- Are affected by neurological disorders affecting bowel function.
- Already underwent previous pelvic radiation or rectal surgery for non-cancer reasons.
- Has a permanent stoma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Liesbet Lauwereins, Msc., +3216379147, liesbet.lauwereins@kuleuven.be
About this study
Official title: Towards Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients Through Precision Medicine
Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection combined with chemoradiotherapy. However, this treatment negatively affects various aspects of bowel function and patients' quality of life. These bowel symptoms often remain prevalent, even 12 months after RC treatment.
The aim of this study is to identify the factors contributing to persistent bowel symptoms and their long-term impact on quality of life following treatment for rectal cancer, assessed 12 months after surgery or stoma closure in surgically treated patients, and 12 months after completion of neoadjuvant therapy in patients managed with active surveillance/watch-and-wait. These insights are crucial for developing an effective care approach, as they help determine when specific evaluations should be conducted and which treatments should be applied at different stages.
- Being tested
- Electronic bowel diary, Faecal Incontinence Quality of Life questionnaire (FIQL), EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)
- Keywords
- Bowel diary, Quality of Life (QoL), Care pathway
- Medical subject headings
- Rectal Neoplasms, Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic bowel diaryDiagnostic test
This bowel diary will be available on the smartphone in the form of an application.
Faecal Incontinence Quality of Life questionnaire (FIQL)Diagnostic test
This questionnaire will be available online.
EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)Diagnostic test
This questionnaire will be available online.
| Study group | Role | What they receive |
|---|---|---|
| TME/PME | Experimental | To investigate the prognostic variables of persistent bowel symptoms and persistent consequences of bowel symptoms, specifically the impact on QoL, participants scheduled for rectal surgery will be asked to complete an electronic bowel diary on their mobile phones and to fill out several online questionnaires at multiple time points (prior to surgery, and at 1, 6, and 12 months post-rectal surgery or post-stoma closure). Receives: Diagnostic Test: Electronic bowel diary; Diagnostic Test: Faecal Incontinence Quality of Life questionnaire (FIQL); Diagnostic Test: EuroQoL 5 dimensions, 5 levels (EQ-5D-5L) |
| Active surveillance | Experimental | To investigate the prognostic variables of persistent bowel symptoms and persistent consequences of bowel symptoms, specifically the impact on QoL, participants in active surveillance will be asked to complete an electronic bowel diary on their mobile phones and to fill out several online questionnaires at multiple time points (at baseline and at 1, 6, and 12 months after completion of neoadjuvant therapy). Receives: Diagnostic Test: Electronic bowel diary; Diagnostic Test: Faecal Incontinence Quality of Life questionnaire (FIQL); Diagnostic Test: EuroQoL 5 dimensions, 5 levels (EQ-5D-5L) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel symptoms after rectal cancer treatment
To ensure that patients can report all their bowel symptoms where they suffer from, a valid, reliable, user-friendly, and easy-to-interpret electronic bowel diary has been developed in another research project for which approval has already been obtained from the Ethical Committee of the University Hospitals Leuven (S68746). This electronic bowel diary will be used to map out all bowel complaints.
Measured: 12 months
The evaluation of Quality of Life (QoL) related to bowel symptoms after rectal cancer treatment
Faecal Incontinence Quality of Life questionnaire (FIQL) will be used for the evaluation of QoL related to faecal incontinence problems. The FIQL is a reliable and valid 41-item questionnaire, resulting in 4 subscales: Lifestyle, Coping/behavior, Depression/Self Perception and Embarrassment. The Scales ranges from 1 to 5, with a 1 indicating a lower functional status of quality of life. This questionnaire is also validated in Dutch.
Measured: 12 months
The evaluation of overall Quality of Life (QoL) after rectal cancer treatment
EuroQol 5 Dimensions, 5 Levels (EQ-5D-5L) will be used to assess overall quality of life (QoL). The EQ-5D-5L is a reliable and valid 6-item questionnaire, consisting of two parts: the social perspective and the individual perspective of one's own health.
In the social perspective, the health state is converted into a value set with a score ranging from 0 to 1, where 0 represents being dead and 1 represents full health. The individual perspective assesses the respondent's own perception of their health, with a score ranging from 0 to 100.
This questionnaire is validated in Dutch and widely used to measure general health-related quality of life.
Measured: 12 months
Secondary outcomes (13)
The predictive value of 'defecation functions' measured with the MSKCC-BFI for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Defecation functions will be assessed with the Memorial Sloan-Kettering Cancer Centre Bowel Function Instrument (MSKCC-BFI). The MSKCC-BFI is a broad bowel specific questionnaire (18 items), resulting in three subscales, four single items and one total score for bowel function.
Measured: 12 months
The predictive value of 'defecation functions' measured with the LARS score for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Defecation functions will be assessed with the LARS score. The LARS score is a short questionnaire, consisting of 5 items, stratifying patients into no, minor or major LARS. This questionnaire has been validated in Dutch.
Measured: 12 months
The predictive value of 'defecation functions' measured with the PAC-SYM for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Defecation functions will be assessed with the Patient Assessment of Constipation-Symptoms questionnaire (PAC-SYM). The PAC-SYM is a validated constipation-specific questionnaire of 12 items that reflect stool, rectal and abdominal symptoms. Patients report the severity of each symptom on a Likert scale from 0 (absent) to 4 (very severe). This questionnaire has been validated in Dutch.
Measured: 12 months
The predictive value of 'baseline age' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Information concerning the patient age will be derived from the medical file.
Measured: pre-operatively, prior to the surgical intervention for rectal cancer
The predictive value of 'gender' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Information concerning the gender of the patient will be derived from the medical file.
Measured: pre-operatively, prior to the surgical intervention for rectal cancer
The predictive value of 'diabetes' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Information concerning diabetes will be derived from the medical file.
Measured: pre-operatively, prior to the surgical intervention for rectal cancer
The predictive value of 'smoking history' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Information concerning smoking history (current, former, never) will be queried.
Measured: pre-operatively, prior to the surgical intervention for rectal cancer
The predictive value of 'BMI' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Information regarding the patient's BMI will be collected pre-operatively.
Measured: pre-operatively, prior to the surgical intervention for rectal cancer
The predictive value of 'depression' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Depression will be measured using the Patient Health Questionnaire (PHQ-9), a 9-item validated Dutch questionnaire with scores ranging from 0 to 27.
Higher scores indicate more severe depression, classifying patients into mild, moderate, moderately severe, or severe depression.
Measured: 12 months
The predictive value of 'anxiety' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item validated Dutch questionnaire with a score range of 0 to 21. Higher scores reflect greater anxiety severity, categorizing patients into mild, moderate, or severe anxiety.
Measured: 12 months
The predictive value of 'resilience' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC), a 10-item questionnaire with scores ranging from 0 to 40, where higher scores indicate greater resilience. The scale was translated into Dutch using the forward-backward translation technique to ensure accuracy.
Measured: 12 months
The predictive value of 'Optimal physiotherapy care' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
The assessment of optimal physiotherapy care for bowel symptoms during and after RC treatment will be defined based on available scientific evidence, guidelines and clinical expertise of the promotors of this project. Through a self-developed questionnaire, patients will be questioned which care they received in order to estimate by the research team whether they received no/suboptimal/optimal PT care.
Measured: at 6 months post-surgery or post-stoma closure
The predictive value of 'Treatment-related factors' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
TNM-stage, tumor height, neoadjuvant therapy, stoma prior to surgery, date rectal cancer surgery, approach rectal resection, surgery technique, reconstruction technique, type of anastomosis, Rullier classification, inferior mesenteric artery ligation, inferior mesenteric vein ligation, type of stoma, date stoma closure, adjuvant therapy, post-operative complication, anastomotic leakage classification, Clavien-Dindo classification will be derived from the medical file.
Measured: At 1 month post-surgery or post-stoma closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start28 Apr 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Delta, Universitair Ziekenhuis Brussel, Ziekenhuis aan de Stroom, AZ Oostende, General Hospital Groeninge, Regionaal Ziekenhuis Heilig Hart Tienen, Meander MC, Amersfoort, the Netherlands, AZORG, UZ Leuven, Leuven, Belgium
- Responsible party
- Principal investigator, Inge Geraerts, KU Leuven
- Investigators
- Inge Geraerts, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914245
- Sponsor's protocol ID
- S69283
- Acronym
- Treatable
- Status last verified
- Jan 2026
- First submitted
- 31 Mar 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients Through Precision Medicine
- ClinicalTrials.gov ID
- NCT06914245
- Acronym / sponsor ID
- Treatable / S69283
- Keywords
- Bowel diary, Quality of Life (QoL), Care pathway
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- AZ Delta, Universitair Ziekenhuis Brussel, Ziekenhuis aan de Stroom, AZ Oostende, General Hospital Groeninge, Regionaal Ziekenhuis Heilig Hart Tienen, Meander MC, Amersfoort, the Netherlands, AZORG, UZ Leuven, Leuven, Belgium
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection combined with chemoradiotherapy. However, this treatment negatively affects various aspects of bowel function and patients' quality of life. These bowel symptoms often remain prevalent, even 12 months after RC treatment.
The aim of this study is to identify the factors contributing to persistent bowel symptoms and their long-term impact on quality of life following treatment for rectal cancer, assessed 12 months after surgery or stoma closure in surgically treated patients, and 12 months after completion of neoadjuvant therapy in patients managed with active surveillance/watch-and-wait. These insights are crucial for developing an effective care approach, as they help determine when specific evaluations should be conducted and which treatments should be applied at different stages.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TME/PME | Experimental | Diagnostic Test: Electronic bowel diary, Diagnostic Test: Faecal Incontinence Quality of Life questionnaire (FIQL), Diagnostic Test: EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)To investigate the prognostic variables of persistent bowel symptoms and persistent consequences of bowel symptoms, specifically the impact on QoL, participants scheduled for rectal surgery will be asked to complete an electronic bowel diary on their mobile phones and to fill out several online questionnaires at multiple time points (prior to surgery, and at 1, 6, and 12 months post-rectal surgery or post-stoma closure). |
| Active surveillance | Experimental | Diagnostic Test: Electronic bowel diary, Diagnostic Test: Faecal Incontinence Quality of Life questionnaire (FIQL), Diagnostic Test: EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)To investigate the prognostic variables of persistent bowel symptoms and persistent consequences of bowel symptoms, specifically the impact on QoL, participants in active surveillance will be asked to complete an electronic bowel diary on their mobile phones and to fill out several online questionnaires at multiple time points (at baseline and at 1, 6, and 12 months after completion of neoadjuvant therapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- At least 18 years of age at the time of signing the Informed Consent Form (ICF).
- Proficient in reading, comprehending, and conversing in Dutch.
- Patients scheduled for Total Mesorectal Excision (TME) or Partial Mesorectal Excision (PME) or 'Watch and wait' protocol due to rectal cancer.
Key exclusion criteria (5 listed)
- The participant has undergone a different type of surgery, including a Hartmann procedure, abdominoperineal excision, transanal endoscopic microsurgery, or sigmoid resection.
- Experienced fecal incontinence prior to undergoing surgery.
- Are affected by neurological disorders affecting bowel function.
- Already underwent previous pelvic radiation or rectal surgery for non-cancer reasons.
- Has a permanent stoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic bowel diaryThis bowel diary will be available on the smartphone in the form of an application. | Diagnostic test | Active surveillance, TME/PME |
| Faecal Incontinence Quality of Life questionnaire (FIQL)This questionnaire will be available online. | Diagnostic test | Active surveillance, TME/PME |
| EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)This questionnaire will be available online. | Diagnostic test | Active surveillance, TME/PME |
Primary outcome
Bowel symptoms after rectal cancer treatment
Time frame: 12 months
To ensure that patients can report all their bowel symptoms where they suffer from, a valid, reliable, user-friendly, and easy-to-interpret electronic bowel diary has been developed in another research project for which approval has already been obtained from the Ethical Committee of the University Hospitals Leuven (S68746). This electronic bowel diary will be used to map out all bowel complaints.
The evaluation of Quality of Life (QoL) related to bowel symptoms after rectal cancer treatment
Time frame: 12 months
Faecal Incontinence Quality of Life questionnaire (FIQL) will be used for the evaluation of QoL related to faecal incontinence problems. The FIQL is a reliable and valid 41-item questionnaire, resulting in 4 subscales: Lifestyle, Coping/behavior, Depression/Self Perception and Embarrassment. The Scales ranges from 1 to 5, with a 1 indicating a lower functional status of quality of life. This questionnaire is also validated in Dutch.
The evaluation of overall Quality of Life (QoL) after rectal cancer treatment
Time frame: 12 months
EuroQol 5 Dimensions, 5 Levels (EQ-5D-5L) will be used to assess overall quality of life (QoL). The EQ-5D-5L is a reliable and valid 6-item questionnaire, consisting of two parts: the social perspective and the individual perspective of one's own health. In the social perspective, the health state is converted into a value set with a score ranging from 0 to 1, where 0 represents being dead and 1 represents full health. The individual perspective assesses the respondent's own perception of their health, with a score ranging from 0 to 100. This questionnaire is validated in Dutch and widely used to measure general health-related quality of life.
13 secondary outcomes
The predictive value of 'defecation functions' measured with the MSKCC-BFI for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Time frame: 12 months
The predictive value of 'defecation functions' measured with the LARS score for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Time frame: 12 months
The predictive value of 'defecation functions' measured with the PAC-SYM for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Time frame: 12 months
The predictive value of 'baseline age' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Time frame: pre-operatively, prior to the surgical intervention for rectal cancer
The predictive value of 'gender' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Time frame: pre-operatively, prior to the surgical intervention for rectal cancer
The predictive value of 'diabetes' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Time frame: pre-operatively, prior to the surgical intervention for rectal cancer
The predictive value of 'smoking history' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Time frame: pre-operatively, prior to the surgical intervention for rectal cancer
The predictive value of 'BMI' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Time frame: pre-operatively, prior to the surgical intervention for rectal cancer
The predictive value of 'depression' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Time frame: 12 months
The predictive value of 'anxiety' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Time frame: 12 months
The predictive value of 'resilience' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Time frame: 12 months
The predictive value of 'Optimal physiotherapy care' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Time frame: at 6 months post-surgery or post-stoma closure
The predictive value of 'Treatment-related factors' for the development of persistent bowel symptoms and consequences of bowel symptoms at 12 months post-surgery or post-stoma closure
Time frame: At 1 month post-surgery or post-stoma closure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Inge Geraerts, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic bowel diary, Faecal Incontinence Quality of Life questionnaire (FIQL) and EuroQoL 5 dimensions, 5 levels (EQ-5D-5L) in people with Rectal Cancer and LARS - Low Anterior Resection Syndrome, run by KU Leuven at 1 site in Belgium.
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 4 inclusion and 5 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 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 Inge Geraerts, PhD (+3216329120, inge.geraerts@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel symptoms after rectal cancer treatment (time frame: 12 months). The study lists 3 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 23 Jan 2026.