Clinical trial · Observational
Translation of the International Consensus Definition of LARS Into a Bowl Dysfunction Severity Scoring Tool (New LARS Score)
A Qualitative Research Study Using Patient Focus Groups to Translate International Consensus Definition of Low Anterior Resection Syndrome (LARS) Into a Bowel Dysfunction Severity Scoring Tool.
NCT05605600CI-TRIAL-00065324completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to develop a new severity scoring tool for Low Anterior Resection Syndrome (LARS) drawing on the international consensus criteria for LARS as well as opinions of patients with lived-experience of LARS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low Anterior Resection Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients with Low Anterior Resection Syndrome
- description
- Patients with lived-experience of anterior resection surgery, who may or may not have subsequently developed bowel dysfunction symptoms, will be invited to take part in a focus group. They will discuss a new questionnaire and the phrasing of the questions, ensuring clarity and reducing the potential variability in interpretation of each question.
Primary outcomes (1)
- measure
- Development of LARS Severity tool
- timeFrame
- 6 months
- description
- Qualitative research methods will be used develop the new tool. A patient focus group will be conducted to review the draft questionnaire and refine question and response wordings.
Secondary outcomes (2)
- measure
- Gain patient opinion on new scoring tool name
- timeFrame
- 6 months
- description
- Focus groups will be asked to rank proposed tool names from 'least favoured' to 'most favoured'. This will be considered along with clinical opinion to derive final tool name.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 years or older * Able and willing to provide informed consent * Undergone an anterior resection for cancer, with current bowel continuity Exclusion Criteria: * Currently undergoing adjuvant therapy * Recurrent or metastatic disease * Unable to participate to complete study procedures (Due to intellectual or cognitive impairment; Due to insufficient English-language skills (oral and written))
References
Publications (0)
Data not yet available
No reference posted for this study.