Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 313617 | Other Identifier | IRAS | |
| 22/PR/0889 | Other Identifier | Wales REC4 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Auckland, New Zealand | OTHER |
| University of Aarhus | OTHER |
| Cambridge University Hospitals NHS Foundation Trust | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Six out of ten patients have significant bowel problems in the first 12 months after surgery to remove their rectum (last bit of bowel), with as many as 4 out of 10 having longer term issues. This is an operation which is most commonly performed to treat bowel cancer. Bowel problems can include having to rush to the toilet, having accidents or leakage into the underwear or difficulty fully emptying the bowels. This condition is called Low Anterior Resection Syndrome, or 'LARS' for short. The definition of Low Anterior Resection Syndrome was developed in 2020 with patient involvement throughout the process so it accurately captures the real-world experience of LARS. This definition is to be used to create a new scoring system to measure the severity of LARS.
The aim of this study is to transform this new definition into a scoring tool which can be used to assess the severity of Low Anterior Resection Syndrome and investigate how well various treatments work for LARS. It is vital to have patients involved throughout this work to ensure that the new score gives an accurate picture of the severity of these symptoms.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Low Anterior Resection Syndrome | 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Development of LARS Severity tool | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gain patient opinion on new scoring tool name | 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. | 6 months |
| Commence initial psychometric evaluation of the New LARS score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The aim of this study is to develop a new scoring tool for Low Anterior Resection Syndrome through patient focus groups. We will identify and recruit patients with lived-experience of anterior resection surgery, who may or may not have subsequently developed bowel dysfunction symptoms.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Julie Cornish | Cardiff and Vale University Health Board | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Julie Cornish | Cardiff | CF14 4XW | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000094123 | Low Anterior Resection Syndrome |
| D015179 | Colorectal Neoplasms |
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be asked to complete the new LARS score tool, along with existing LARS tool to test proposed question set and administration method as well as comparability to existing tool. |
| 6 months |
| D011183 |
| Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |