About this trial
1.1 Polyps or tumours in the lower part of the bowel (rectum) can be removed using instruments inserted through the bottom which avoids major surgery and the possibility of a stoma bag (colostomy). Afterwards, it is important to check the area with regular camera tests. If checks are delayed, re-growths could be serious and may be untreatable. COVID and other factors have led to long waiting lists for camera checks and in NHS Lothian around 20% of all camera checks are done more than 6 months late.
The investigators want to try a new camera and approach that would allow us to reduce waiting lists. Using a short camera called a 'rectoscope' to check the lower bowel has already been shown to be safe, comfortable and acceptable to patients with other conditions. In fact, patients are unlikely to feel or realise any difference between the rectoscope and standard camera tests.
The investigators want to show that this 'rectoscope' can be safely used in the outpatient clinic with an enema (suppository) instead of strong bowel medicine taken by mouth the day before. This would mean the camera checks happen on time and would reduce waiting lists for other important tests.
The investigators will include 30 patients across three stages of our study. In the first set of patients, the investigators will use the rectoscope alongside the usual endoscope in the endoscopy room using the usual oral bowel medicine. This stage will check the rectoscope is acceptable to the patient and the doctor. In the next 10 patients the investigators will use a suppository instead of oral bowel medicine still using both cameras. Finally, the investigators will use the rectoscope in the outpatient clinic with an suppository to show this is an easy, effective and acceptable way to deliver timely camera checks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
All patients must have had a rectal tumour/ polyp removed within easy reach of the rigid sigmoidoscope undergoing post-operative surveillance.
Trial design
Cohort
Prospective
Treatments tested in this trial
LumenEye X1 digital rectoscope
Diagnostic testThe LumenEye X1 is a novel digital rectoscope that introduces digital HD imaging and improved ergonomics to conventional rigid sigmoidoscopy.
Treatment groups
Trial outcomes
Primary outcomes
Analysis of diagnostic accuracy
LumenEye for the Detection of Rectal Pathology Including Tumour, Polyps and Inflammation. To provide pilot data within the small study for the diagnostic accuracy of the LumenEye system as compared to conventional flexible endoscopy. In the first 2 stages of the study LumenEye will be compared against flexible sigmoidoscopy. Sigmoidoscopy will be considered the gold standard and will be performed directly after the LumenEye procedure. Accuracy will be calculated in standard fashion based on observations of true / false positive/ negative observations alongside measures of sensitivity and specificity.
Secondary outcomes
Clinician Experience of LumenEye Examination
Assessing the the positive response rate by examining clinicians to their overall experience and certainty of diagnosis for each examination. Confidence in LumenEye findings and overall clinician experience will be measured using a standard 4-5 point likert scale.
Patient Experience of LumenEye Examination
Assessing the percentage of participants with positive responses to the patient experience questionnaire, which is answered with a 5 point Likert scale. Questions are as follows: The LumenEye examination was comfortable: Strongly disagree / Disagree / Neutral / Agree / Strongly agree If needed, I would be willing to undergo a further examination with a LumenEye in future Strongly disagree / Disagree / Neutral / Agree / Strongly agree What is your overall opinion of your experience with LumenEye assessment? Very poor / Poor / Neutral / Positive / Very positive The flexible sigmoidoscopy examination was comfortable: Strongly disagree / Disagree / Neutral / Agree / Strongly agree
Sponsors and contacts
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University of Edinburgh
Lead sponsor
NHS Lothian
Collaborator
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