Clinical trial · Observational
Use of a Novel Camera to Check the Bowel After Polyp or Tumour Removal
Surveillance Digital Rectoscopy After Local Excision of Rectal Tumours
- 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)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bowel Cancer | Malignant Intestinal Neoplasm | ALIAS | 0.90 |
| Polyp Rectal | — | UNRESOLVED | — |
| Rectal Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Rectal Adenoma | Rectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LumenEye X1 digital rectoscope | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Surveillance cohort
- description
- Patients undergoing surveillance following rectal tumour removal
- interventionNames
- Diagnostic Test: LumenEye X1 digital rectoscope
Primary outcomes (1)
- measure
- Analysis of diagnostic accuracy
- timeFrame
- Baseline
- description
- 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 (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: All participants who are capable of giving informed consent. All participants aged 16 years or over. All patients must have had a rectal tumour/ polyp removed within easy reach of the rigid sigmoidoscope. All participants must be resident in the United Kingdom. Exclusion Criteria: Unable to give informed consent. Under the age of 16 years
References
Publications (7)
- BACKGROUNDHyun JH, Alhanafy MK, Park HC, Park SM, Park SC, Sohn DK, Kim DW, Kang SB, Jeong SY, Park KJ, Oh JH. Initial local excision for clinical T1 rectal cancer showed comparable overall survival despite high local recurrence rate: a propensity-matched analysis. Ann Coloproctol. 2022 Apr;38(2):166-175. doi: 10.3393/ac.2021.00479.0068. Epub 2021 Oct 6. PMID 34610653
- BACKGROUNDRullier E, Vendrely V, Asselineau J, Rouanet P, Tuech JJ, Valverde A, de Chaisemartin C, Rivoire M, Trilling B, Jafari M, Portier G, Meunier B, Sieleznieff I, Bertrand M, Marchal F, Dubois A, Pocard M, Rullier A, Smith D, Frulio N, Frison E, Denost Q. Organ preservation with chemoradiotherapy plus local excision for rectal cancer: 5-year results of the GRECCAR 2 randomised trial. Lancet Gastroenterol Hepatol. 2020 May;5(5):465-474. doi: 10.1016/S2468-1253(19)30410-8. Epub 2020 Feb 7. PMID 32043980
- BACKGROUNDBach SP, Gilbert A, Brock K, Korsgen S, Geh I, Hill J, Gill T, Hainsworth P, Tutton MG, Khan J, Robinson J, Steward M, Cunningham C, Levy B, Beveridge A, Handley K, Kaur M, Marchevsky N, Magill L, Russell A, Quirke P, West NP, Sebag-Montefiore D; TREC collaborators. Radical surgery versus organ preservation via short-course radiotherapy followed by transanal endoscopic microsurgery for early-stage rectal cancer (TREC): a randomised, open-label feasibility study. Lancet Gastroenterol Hepatol. 2021 Feb;6(2):92-105. doi: 10.1016/S2468-1253(20)30333-2. Epub 2020 Dec 11. PMID 33308452
- BACKGROUNDBrachet S, Meillat H, Chanez B, Ratone JP, Brunelle S, Tyran M, Poizat F, de Chaisemartin C, Lelong B. Case-Matched Comparison of Functional and Quality of Life Outcomes of Local Excision and Total Mesorectal Excision Following Chemoradiotherapy for Rectal Cancer. Dis Colon Rectum. 2022 Dec 1;65(12):1464-1474. doi: 10.1097/DCR.0000000000002384. Epub 2022 Jul 27. PMID 35913830
- BACKGROUNDBuess G, Theiss R, Hutterer F, Pichlmaier H, Pelz C, Holfeld T, Said S, Isselhard W. [Transanal endoscopic surgery of the rectum - testing a new method in animal experiments]. Leber Magen Darm. 1983 Mar;13(2):73-7. German.