Rectal CancerTreatableNCT06274190
Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary
A study testing bowel e-diary 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
- What is being tested?
- bowel e-diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Apr 2024to Jul 2026
- 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 after rectal surgery for rectal cancer or under Watch and Wait protocol (also referred to as active surveillance).
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.
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., 016379147, 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 will negatively impact different aspects of bowel function and the patients' quality of life. These bowel symptoms often remain prevalent, even at 12 months after RC treatment. Most assessment tools are however not capable of capturing the full range or therapeutic-related evolution of these bowel symptoms. Consequently, the aim is to develop a validated bowel diary for diagnosing and evaluation of all bowel symptoms.
In recent years, organ-preserving strategies such as Watch and Wait have become more widely implemented. Although these patients avoid surgical morbidity, emerging evidence shows that neoadjuvant radiotherapy alone can also cause substantial and persistent bowel dysfunction. Therefore, the study population was expanded to include patients managed with a Watch and Wait strategy in addition to those undergoing TME/PME.
Read the detailed description
Colorectal cancer is the 2nd and 3rd most common cancer in women and men, respectively and represents approximately 13% of all new cancer diagnoses, with 40% of cases specifically situated in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, given the improved oncological results, functional outcomes, such as bowel symptoms, become more and more important. Approximately 60-90% of RC patients are affected with a wide range of new onset bowel symptoms (incontinence for flatus or feces (solid, liquid), frequent bowel movements, urgency, clustering of defecation and evacuation problems) immediately after rectal treatment. The combination of these specific bowel symptoms and their impact on quality of life (QoL) has been summarized in an international consensus definition and is referred to as the Low Anterior Resection Syndrome (LARS).
Major LARS has an important impact on QoL and has major health economic consequences. This is attributable to its high prevalence after RC treatment, the chronic nature of symptoms and the limited evidence of available therapeutic options. This context leads to repetitive medical consultations, additional technical examinations which are often not very useful and need for prolonged medical treatment (multiple drug regimens), with often limited therapeutic gain. Furthermore, there is a lack of a comprehensive scoring system to identify the different aspects of LARS, leading to inadequate diagnostics and follow-up of symptoms. Based on these considerations, there is a clear need for a comprehensive scoring system for identification of the different aspects of LARS and monitoring of therapeutic treatment.
In recent years, organ-preserving strategies such as Watch and Wait have gained importance in the management of rectal cancer. Although these patients avoid surgical morbidity, growing evidence shows that neoadjuvant radiotherapy alone can also induce substantial and persistent bowel dysfunction, likely due to radiation scatter affecting adjacent pelvic structures. As Watch and Wait is increasingly implemented in clinical practice, it is essential that this patient group is included in the development of a comprehensive scoring system to accurately capture the full spectrum and evolution of bowel symptoms across all treatment pathways.
- Being tested
- bowel e-diary
- 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.
bowel e-diaryDiagnostic test
This bowel diary will be available on the smartphone in the form of an application.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Delphi patient focus group | No intervention | During this focus group, we aim to achieve various goals: * To gain insight into the bowel symptoms and the consequences patients experienced after treating rectal cancer * To understand the expectations of the patients regarding an electronic bowel diary * To determine whether the questions/items derived from the literature study for the bowel diary are clear and understandable for the patients * To explore other relevant questions/items that should be added to the bowel diary We will include 8-12 patients in this focus group. |
| Delphi survey | No intervention | In this Delphi survey, a multidisciplinary group of experts and patients will score each item of the long list on a 1-9-point Likert scale from 'Not relevant' (1) to 'Essential' (9) for inclusion in the bowel diary. Finally, a patient consultation meeting and a consensus meeting will be held for the participants who completed the Delphi survey. We will recruit 10-18 Delphi panelists per area of expertise. These panelists are experts with international expert recognition in treating bowel symptoms in the following health care categories (abdominal surgeons, digestive/radiation oncologists, specialized pelvic floor muscle physiotherapists, nursing specialists). In addition, we will include one group comprising 10-18 patients in the Delphi survey, ensuring a comprehensive and holistic perspective on treating bowel symptoms across various healthcare categories. |
| Post-Delphi patient focus group | No intervention | During this focus group, our objective is to ensure that both the questions and answers are meaningful. We will include 8-12 patients in this focus group. |
| Usability of e-diary | Experimental | The participants will be asked to use the newly developed electronic bowel diary for 7 consecutive days.
To evaluate the usability of the e-diary, a group of 10 patients will participate in the assessment using the System Usability Scale (SUS).
Furthermore we will have conversations with these patients regarding the use of the application: complexity, need for additional support, coherence of the application, user-friendliness, and the need for prior knowledge. Receives: Diagnostic Test: bowel e-diary |
| Psychometric properties of e-diary | Experimental | To assess the validity of the e-diary (test-retest reliability, construct validity and responsiveness), participants who underwent rectal cancer surgery will complete the e-diary during two distinct 7-day periods. Receives: Diagnostic Test: bowel e-diary |
| Bowel symptoms in Watch and Wait | Experimental | To explore the type and severity of bowel symptoms in patients managed with a Watch and Wait strategy, participants will complete the e-diary during two distinct 7-day periods. Receives: Diagnostic Test: bowel e-diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selection of items for the newly developed bowel diary
The selection of items for a comprehensive bowel diary in patients with rectal cancer is based on a literature review, a patient focus group and an international Delphi survey. The patient focus group is recorded using an audio and video recording. This recording is transcribed verbatim by the researcher into a Word document. The transcription will be analyzed using NVIVO 9 software. In this Delphi survey, a multidisciplinary group of experts will score each item of the long list on a 1-9-point Likert scale from 'Not relevant' (1) to 'Essential' (9) for inclusion in the bowel diary. Finally, a patient consultation meeting and a consensus meeting will be held for the participants who completed the Delphi survey.
Measured: 12 months
Assessment of content validity of the newly developed bowel diary in a post-Delphi patient focus group consisting of 8-12 participants
Content validation of the newly developed bowel diary will be tested during interview in the post-Delphi patient focus group. This focus group is recorded using an audio and video recording. This recording are transcribed verbatim by the researcher into a Word document. The transcription will be analyzed using NVIVO 9 software.
Measured: 12 months
The usability of the newly developed e-diary, assessed with the System Usability Scale (SUS) in patients after rectal surgery for rectal cancer
The participants will be asked to use a newly developed electronic bowel diary for 7 consecutive days. This bowel diary will be available on the smartphone in the form of an application. After 7 days, the usability of this e-diary will be assessed with the System Usability Scale (SUS). The SUS is a questionnaire consisting of 10 items, utilizing a 5-point Likert scale to measure users' perceived satisfaction with the system. It includes two subscales focusing on usability and learnability. Scores on the SUS range from 0 to 100, with no direct correlation to percentiles (i.e., a score of 60 does not signify a usability level of 60%). Instead, a score of 70 points or higher is commonly employed as an initial threshold indicating acceptable usability. This benchmark is derived from the overall mean of more than 200 studies covering various systems and products.
Measured: 12 months
The usability of the newly developed e-diary will be evaluated through conversations with patients who have undergone rectal surgery for rectal cancer, after these patients have used the e-diary for seven consecutive days
Participants will be instructed to use a newly developed electronic bowel diary via a smartphone app for seven consecutive days. The research will then conduct conversations with the participants covering aspects such as complexity, the need for additional support, application coherence, user-friendliness, pre-existing knowledge requirements, and suggestions for improvement. Audio and video recordings of these conversations will be transferred to the researcher's computer and subsequently transcribed into a Word document. The transcriptions will be analyzed using NVIVO 9 software.
Measured: 12 months
Construct validity of the newly developed bowel e-diary: Known groups method
Patients will be divided into two groups based on their LARS score: no/minor LARS and major LARS. Over a 7-day period, patients will be asked to complete the bowel diary, which will then be examined to determine if there is a meaningful difference between the two groups. The Mann-Whitney U-test will be used to assess whether the difference is significant, and the C-index will be calculated to evaluate how well the test distinguishes between the groups. A C-index of 0.65 or higher would indicate that the test is effective at differentiating between the groups.
Measured: 12 months
Construct validity of the newly developed bowel e-diary: Convergent and divergent validity
The bowel diary will be completed by patients over a 7-day period, while the questionnaires (such as LARS, MSKCC-BFI, COREFO, PAC-SYM, QLQ-C30) will be filled out on day 7.
The correlation between the bowel diary and the questionnaires (such as LARS, MSKCC-BFI, COREFO, PAC-SYM, QLQ-C30) will be calculated. The correlation will be performed across the entire set of questionnaires and bowel diary items, while pairwise correlations at the subscale level will analyze the relationship between related factors.
Measured: 12 months
Test-retest reliability of the newly developed bowel e-diary
To investigate the test-retest reliability of the newly developed bowel e-diary, patients will have to fill out the bowel diary application twice, each time for a continuous period of 7 days, during a period when the disorder and treatment do not change (i.e., after the end of adjuvant treatment and/or after closure of an eventual temporary postoperative ileostomy).
Measured: 12 months
Responsiveness of the newly developed bowel e-diary in patients after rectal surgery for rectal cancer. The newly validated e-diary is the primary outcome.
To evaluate the responsiveness of the new bowel diary, patients will complete the diary for 14 consecutive days. The first 7 days (day 1-7) will be compared with the following 7 days (day 7-14). Internal responsiveness will be calculated using the Standardized Response Mean (SRM) for the bowel diary. External responsiveness will be assessed by calculating the SRM for both the bowel diary and the LARS score and MSKCC-BFI questionnaires.
Measured: 12 months
Explorative analysis of bowel symptoms in Watch and Wait
To exploratively analyse the type and severity of bowel symptoms in patients managed with a Watch and Wait strategy, and to compare these symptoms with those reported by patients who underwent TME/PME surgery.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start29 Apr 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Inge Geraerts, KU Leuven
- Investigators
- Inge Geraerts, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274190
- Sponsor's protocol ID
- S68746
- Acronym
- Treatable
- Status last verified
- Apr 2026
- First submitted
- 31 Jan 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lauwereins L, D'Hoore A, Coeckelberghs E, Wolthuis A, Bislenghi G, Haustermans K, Rasschaert G, Dekervel J, Debrun L, Castro EM, Devoogdt N, De Groef A, Vanderheyden H, Geraerts I; Bowel Diary Research group. Development of S.Tool: An electronic diary for assessing bowel symptoms after rectal cancer surgery. Eur J Surg Oncol. 2026 May;52(5):111755. doi: 10.1016/j.ejso.2026.111755. Epub 2026 Mar 23.
PubMed 41894921
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 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
- NCT06274190
- Acronym / sponsor ID
- Treatable / S68746
- Keywords
- Bowel diary, Quality of Life (QoL), Care pathway
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 23 Feb 2024 (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 will negatively impact different aspects of bowel function and the patients' quality of life. These bowel symptoms often remain prevalent, even at 12 months after RC treatment. Most assessment tools are however not capable of capturing the full range or therapeutic-related evolution of these bowel symptoms. Consequently, the aim is to develop a validated bowel diary for diagnosing and evaluation of all bowel symptoms.
In recent years, organ-preserving strategies such as Watch and Wait have become more widely implemented. Although these patients avoid surgical morbidity, emerging evidence shows that neoadjuvant radiotherapy alone can also cause substantial and persistent bowel dysfunction. Therefore, the study population was expanded to include patients managed with a Watch and Wait strategy in addition to those undergoing TME/PME.
Detailed description
Colorectal cancer is the 2nd and 3rd most common cancer in women and men, respectively and represents approximately 13% of all new cancer diagnoses, with 40% of cases specifically situated in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, given the improved oncological results, functional outcomes, such as bowel symptoms, become more and more important. Approximately 60-90% of RC patients are affected with a wide range of new onset bowel symptoms (incontinence for flatus or feces (solid, liquid), frequent bowel movements, urgency, clustering of defecation and evacuation problems) immediately after rectal treatment. The combination of these specific bowel symptoms and their impact on quality of life (QoL) has been summarized in an international consensus definition and is referred to as the Low Anterior Resection Syndrome (LARS).
Major LARS has an important impact on QoL and has major health economic consequences. This is attributable to its high prevalence after RC treatment, the chronic nature of symptoms and the limited evidence of available therapeutic options. This context leads to repetitive medical consultations, additional technical examinations which are often not very useful and need for prolonged medical treatment (multiple drug regimens), with often limited therapeutic gain. Furthermore, there is a lack of a comprehensive scoring system to identify the different aspects of LARS, leading to inadequate diagnostics and follow-up of symptoms. Based on these considerations, there is a clear need for a comprehensive scoring system for identification of the different aspects of LARS and monitoring of therapeutic treatment.
In recent years, organ-preserving strategies such as Watch and Wait have gained importance in the management of rectal cancer. Although these patients avoid surgical morbidity, growing evidence shows that neoadjuvant radiotherapy alone can also induce substantial and persistent bowel dysfunction, likely due to radiation scatter affecting adjacent pelvic structures. As Watch and Wait is increasingly implemented in clinical practice, it is essential that this patient group is included in the development of a comprehensive scoring system to accurately capture the full spectrum and evolution of bowel symptoms across all treatment pathways.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pre-Delphi patient focus group | No intervention | –During this focus group, we aim to achieve various goals: * To gain insight into the bowel symptoms and the consequences patients experienced after treating rectal cancer * To understand the expectations of the patients regarding an electronic bowel diary * To determine whether the questions/items derived from the literature study for the bowel diary are clear and understandable for the patients * To explore other relevant questions/items that should be added to the bowel diary We will include 8-12 patients in this focus group. |
| Delphi survey | No intervention | –In this Delphi survey, a multidisciplinary group of experts and patients will score each item of the long list on a 1-9-point Likert scale from 'Not relevant' (1) to 'Essential' (9) for inclusion in the bowel diary. Finally, a patient consultation meeting and a consensus meeting will be held for the participants who completed the Delphi survey. We will recruit 10-18 Delphi panelists per area of expertise. These panelists are experts with international expert recognition in treating bowel symptoms in the following health care categories (abdominal surgeons, digestive/radiation oncologists, specialized pelvic floor muscle physiotherapists, nursing specialists). In addition, we will include one group comprising 10-18 patients in the Delphi survey, ensuring a comprehensive and holistic perspective on treating bowel symptoms across various healthcare categories. |
| Post-Delphi patient focus group | No intervention | –During this focus group, our objective is to ensure that both the questions and answers are meaningful. We will include 8-12 patients in this focus group. |
| Usability of e-diary | Experimental | Diagnostic Test: bowel e-diaryThe participants will be asked to use the newly developed electronic bowel diary for 7 consecutive days. To evaluate the usability of the e-diary, a group of 10 patients will participate in the assessment using the System Usability Scale (SUS). Furthermore we will have conversations with these patients regarding the use of the application: complexity, need for additional support, coherence of the application, user-friendliness, and the need for prior knowledge. |
| Psychometric properties of e-diary | Experimental | Diagnostic Test: bowel e-diaryTo assess the validity of the e-diary (test-retest reliability, construct validity and responsiveness), participants who underwent rectal cancer surgery will complete the e-diary during two distinct 7-day periods. |
| Bowel symptoms in Watch and Wait | Experimental | Diagnostic Test: bowel e-diaryTo explore the type and severity of bowel symptoms in patients managed with a Watch and Wait strategy, participants will complete the e-diary during two distinct 7-day periods. |
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 after rectal surgery for rectal cancer or under Watch and Wait protocol (also referred to as active surveillance).
Key exclusion criteria (4 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.
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 |
|---|---|---|
| bowel e-diaryThis bowel diary will be available on the smartphone in the form of an application. | Diagnostic test | Bowel symptoms in Watch and Wait, Psychometric properties of e-diary, Usability of e-diary |
Primary outcome
Selection of items for the newly developed bowel diary
Time frame: 12 months
The selection of items for a comprehensive bowel diary in patients with rectal cancer is based on a literature review, a patient focus group and an international Delphi survey. The patient focus group is recorded using an audio and video recording. This recording is transcribed verbatim by the researcher into a Word document. The transcription will be analyzed using NVIVO 9 software. In this Delphi survey, a multidisciplinary group of experts will score each item of the long list on a 1-9-point Likert scale from 'Not relevant' (1) to 'Essential' (9) for inclusion in the bowel diary. Finally, a patient consultation meeting and a consensus meeting will be held for the participants who completed the Delphi survey.
Assessment of content validity of the newly developed bowel diary in a post-Delphi patient focus group consisting of 8-12 participants
Time frame: 12 months
Content validation of the newly developed bowel diary will be tested during interview in the post-Delphi patient focus group. This focus group is recorded using an audio and video recording. This recording are transcribed verbatim by the researcher into a Word document. The transcription will be analyzed using NVIVO 9 software.
The usability of the newly developed e-diary, assessed with the System Usability Scale (SUS) in patients after rectal surgery for rectal cancer
Time frame: 12 months
The participants will be asked to use a newly developed electronic bowel diary for 7 consecutive days. This bowel diary will be available on the smartphone in the form of an application. After 7 days, the usability of this e-diary will be assessed with the System Usability Scale (SUS). The SUS is a questionnaire consisting of 10 items, utilizing a 5-point Likert scale to measure users' perceived satisfaction with the system. It includes two subscales focusing on usability and learnability. Scores on the SUS range from 0 to 100, with no direct correlation to percentiles (i.e., a score of 60 does not signify a usability level of 60%). Instead, a score of 70 points or higher is commonly employed as an initial threshold indicating acceptable usability. This benchmark is derived from the overall mean of more than 200 studies covering various systems and products.
The usability of the newly developed e-diary will be evaluated through conversations with patients who have undergone rectal surgery for rectal cancer, after these patients have used the e-diary for seven consecutive days
Time frame: 12 months
Participants will be instructed to use a newly developed electronic bowel diary via a smartphone app for seven consecutive days. The research will then conduct conversations with the participants covering aspects such as complexity, the need for additional support, application coherence, user-friendliness, pre-existing knowledge requirements, and suggestions for improvement. Audio and video recordings of these conversations will be transferred to the researcher's computer and subsequently transcribed into a Word document. The transcriptions will be analyzed using NVIVO 9 software.
Construct validity of the newly developed bowel e-diary: Known groups method
Time frame: 12 months
Patients will be divided into two groups based on their LARS score: no/minor LARS and major LARS. Over a 7-day period, patients will be asked to complete the bowel diary, which will then be examined to determine if there is a meaningful difference between the two groups. The Mann-Whitney U-test will be used to assess whether the difference is significant, and the C-index will be calculated to evaluate how well the test distinguishes between the groups. A C-index of 0.65 or higher would indicate that the test is effective at differentiating between the groups.
Construct validity of the newly developed bowel e-diary: Convergent and divergent validity
Time frame: 12 months
The bowel diary will be completed by patients over a 7-day period, while the questionnaires (such as LARS, MSKCC-BFI, COREFO, PAC-SYM, QLQ-C30) will be filled out on day 7. The correlation between the bowel diary and the questionnaires (such as LARS, MSKCC-BFI, COREFO, PAC-SYM, QLQ-C30) will be calculated. The correlation will be performed across the entire set of questionnaires and bowel diary items, while pairwise correlations at the subscale level will analyze the relationship between related factors.
Test-retest reliability of the newly developed bowel e-diary
Time frame: 12 months
To investigate the test-retest reliability of the newly developed bowel e-diary, patients will have to fill out the bowel diary application twice, each time for a continuous period of 7 days, during a period when the disorder and treatment do not change (i.e., after the end of adjuvant treatment and/or after closure of an eventual temporary postoperative ileostomy).
Responsiveness of the newly developed bowel e-diary in patients after rectal surgery for rectal cancer. The newly validated e-diary is the primary outcome.
Time frame: 12 months
To evaluate the responsiveness of the new bowel diary, patients will complete the diary for 14 consecutive days. The first 7 days (day 1-7) will be compared with the following 7 days (day 7-14). Internal responsiveness will be calculated using the Standardized Response Mean (SRM) for the bowel diary. External responsiveness will be assessed by calculating the SRM for both the bowel diary and the LARS score and MSKCC-BFI questionnaires.
Explorative analysis of bowel symptoms in Watch and Wait
Time frame: 12 months
To exploratively analyse the type and severity of bowel symptoms in patients managed with a Watch and Wait strategy, and to compare these symptoms with those reported by patients who underwent TME/PME surgery.
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 15 Apr 2026.
- Derived from this study: PubMed 41894921Lauwereins L, D'Hoore A, Coeckelberghs E, Wolthuis A, Bislenghi G, Haustermans K, Rasschaert G, Dekervel J, Debrun L, Castro EM, Devoogdt N, De Groef A, Vanderheyden H, Geraerts I; Bowel Diary Research group. Development of S.Tool: An electronic diary for assessing bowel symptoms after rectal cancer surgery. Eur J Surg Oncol. 2026 May;52(5):111755. doi: 10.1016/j.ejso.2026.111755. Epub 2026 Mar 23.
- 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 bowel e-diary 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 4 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 15 Apr 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?
Selection of items for the newly developed bowel diary (time frame: 12 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06274190, which also lists 1 linked publication.
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 15 Apr 2026.