An interventional study of Electronic bowel diary and Faecal Incontinence Quality of Life questionnaire (FIQL) in Rectal Cancer, LARS - Low Anterior Resection Syndrome and Active Surveillance, sponsored by KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by KU Leuven · Not applicable, Interventional, and Supportive care
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 150 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
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Exclusion Criteria:
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).
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).
Diagnostic Test: Electronic bowel diary · Diagnostic Test: Faecal Incontinence Quality of Life questionnaire (FIQL) · Diagnostic Test: EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)
This bowel diary will be available on the smartphone in the form of an application.
This questionnaire will be available online.
This questionnaire will be available online.
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
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.
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
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.
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
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.
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
Information concerning the patient age will be derived from the medical file.
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
Information concerning the gender of the patient will be derived from the medical file.
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
Information concerning diabetes will be derived from the medical file.
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
Information concerning smoking history (current, former, never) will be queried.
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
Information regarding the patient's BMI will be collected pre-operatively.
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
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.
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
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.
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
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.
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
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.
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
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.
Time frame: At 1 month post-surgery or post-stoma closure
Plan to share: Undecided
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