Surveillance Digital Rectoscopy After Local Excision of Rectal Tumours
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Analysis of diagnostic accuracy
研究概览
简要总结
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.
详细描述
BACKGROUND Transanal excision of rectal tumours describes the excision of both benign and malignant rectal lesions avoiding the need for major rectal resection. Traditional transanal approaches facilitated the excision of lower third rectal tumours using a trans-anal retractor. Since its introduction in the 1980s, transanal endoscopic microsurgery (TEMS) has established itself as an oncologically effective and safe approach to transanal excision of neoplasms throughout the rectum. More recent developments using laparoscopic (TAMIS) and now robotic platforms (R-TAMIS) provide alternative approaches. Local excision techniques are associated with reduced comorbidity when compared with radical rectal resection (i.e. Total Mesorectal Excision, TME) e.g. death, bleeding, genito-urinary dysfunction and anastomotic leak and need for a stoma. The development and evolution of neo-adjuvant therapy for rectal cancer with significant rates of complete response, demonstrates the potential for organ preservation and may be used alongside local excision techniques, as studied in the TREK, STAR-TREK and GRECCAR-2.
However, it is suggested that when performed for cancer, oncological outcomes may be poorer in patients undergoing local excision compared to radical resection. Current evidence regarding recurrence and survival rates is inconsistent, with some studies suggesting equivalent outcomes, but other studies reporting worse oncological outcomes. As such, regular, high quality post-operative surveillance of the rectum in patients under local excision is critical. Current methods of surveillance for the detection of recurrence commonly include multimodal radiological cross-sectional imaging (magnetic resonance imaging (MRI) and computerised tomography (CT)) and endoscopic (flexible sigmoidoscopy/colonoscopy) surveillance. There are currently no established UK guidelines for surveillance of this patient cohort, yet it is clear that even where local excision of a benign lesion is performed, endoscopic surveillance remains critical in identifying and managing recurrence or metachronous rectal pathology.
1.2 RATIONALE FOR STUDY
COVID-19 had a seismic impact on the provision of care across medicine, not least on the delivery of timely endoscopic examinations, resulting in a significant reduction in activity and exponential increase in waiting times which persists to date. Surveillance procedures are perhaps most at risk of delays, especially when triaged against patients with positive faecal immunohistochemistry tests (FIT) with a high chance of significant pathology. Local data indicates poor compliance with surveillance schedules (Table 1) particularly for endoscopic procedures. In total 20.8% of flexible sigmoidoscopy requests for surveillance after TEMS rectal cancer excision were performed 6 or more months after the scheduled time.
Year 1 2 3 Months 4 8 12 18 24 30 36 Total Number of Patients 36 34 34 33 32 32 32 Pelvic MRI 20 (56%) 15 (44%) 11 (32%) 10 (30%) 6 (19%) 5 (16%) 1 (3%) CT (CAP) 14 (41%) 8 (25%) 3 (9%) Flexible Sigmoidoscopy 15 (42%) 6 (18%) 8 (24%) 7 (21%) 2 (6%) 2 (6%) 2 (6%) Table 1 - Number (%) of Patients Receiving Surveillance <1 month from scheduled date
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Unable to give informed consent. Under the age of 16 years
研究组 & 干预措施
Surveillance cohort
Patients undergoing surveillance following rectal tumour removal
干预措施: LumenEye X1 digital rectoscope (Diagnostic Test)
结局指标
主要结局
Analysis of diagnostic accuracy
时间窗: Baseline
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.
次要结局
- Clinician Experience of LumenEye Examination(Baseline)
- Patient Experience of LumenEye Examination(Baseline)
