Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Number of patients with full colonic exploration and detection of lesions
研究概览
简要总结
The study will compare the diagnostic efficacy of the VCC (PillCam COLON 2) to standard colonoscopy in patients with prior colorectal surgery.
The hypothesis is to validate the VCC as a means of screening for colonic polyps after resection, which would avoid a colonoscopy with its associated general anesthesia and potential side effects.
详细描述
Standard care after colorectal surgery is colon surveillance by standard colonoscopy with its benefits (gold standard examination, resection of lesions) and disadvantages (acceptability, general anesthesia, availability of qualified personnel, risk of perforation and associated gastrointestinal bleeding).
Use of a video-capsule (VCC) is a new, non-invasive technique, that allows to visualize the colon as a whole. This technique has the advantage of not requiring general anesthesia or air insufflation. The examination is performed as an outpatient procedure and therefore does not require hospitalization.
In previous studies, PillCam COLON 2 showed a good sensitivity and specificity in detecting colorectal lesions. However, its use requires an excellent bowel preparation.
To date, no study has been conducted using the VCC in monitoring patients with prior colorectal surgery, especially on the passage of the VCC through surgical anastomosis. No information on VCC capabilities to view and recognize surgical anastomoses and VCC transit time in surgically modified colon is available. The possibility to precisely locate a colorectal lesion prior to surgery, using the VCC, also remains to be studied.
The study requires a 2-month patient participation. The planned total study duration is 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient between 18 and 85 years old
- •patient with greater than 3 month follow-up for colorectal resection with ileo-colic , colo-colic or colorectal anastomosis, regardless of etiology
- •patient requiring a colonoscopy for regular medical care
- •absence of contra-indication to anesthesia and to colonoscopy conduct
- •patient able to understand the study related information and to provide written informed consent
- •patient registered with the French social security regime
- •Non-inclusion Criteria:
- •absence of written informed consent
- •patient having had a total colectomy
- •patient with terminal stoma
- •patient with clinical suspicion of intestinal stenosis and/or anastomotic stenosis
- •patient with known Zenker diverticulum
- •patient wearing a pacemaker or any other internal electronic medical device
- •patient with deglutition disorders and/or altered state of consciousness
- •patient with serious disease preventing planned study procedures
- •pregnant or breast-feeding woman
- •patient within exclusion period from other clinical trial
- •patient having forfeited their freedom of an administrative or legal obligation
- •patient being under guardianship
排除标准
- 未提供
研究组 & 干预措施
PillCam COLON 2 and Standard Colonoscopy
Patients will have videocapsule colonoscopy after bowel preparation, followed by standard colonoscopy the next day.
Interventions:
- Device: PillCam COLON 2 on D0
- Procedure: Standard colonoscopy on D1
干预措施: PillCam Colon 2 (Device)
PillCam COLON 2 and Standard Colonoscopy
Patients will have videocapsule colonoscopy after bowel preparation, followed by standard colonoscopy the next day.
Interventions:
- Device: PillCam COLON 2 on D0
- Procedure: Standard colonoscopy on D1
干预措施: Colonoscopy (Procedure)
结局指标
主要结局
Number of patients with full colonic exploration and detection of lesions
时间窗: By the end of both procedures (Day 1)
Number of patients for whom the capsule allowed for full colonic exploration and presence/absence of colorectal lesions detected by VCC compared to conventional colonoscopy
次要结局
- Quality of colic preparation(By the end of both procedures (Day 1))
- Anastomosis visualization(Prior to colonoscopy on Day 1)
- Number and size of detected lesions(By the end of both procedures (Day 1))
- Adverse events related to VCC exam and colonoscopy(Until end of Day 1)
- Patient's assessment of tolerability and acceptance(Follow up visit (between Day 15 and Day 30))
- Health-economic assessment(End of follow-up (between D15 and D30))
- Times related to videocapsule(Prior to colonoscopy on Day 1)