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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01475-38 | Other Identifier | ANSM France |
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Operational difficulties related to medical staff turnover (investigators departure and sickness leave).
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PillCam COLON 2 and Standard Colonoscopy | Experimental | Patients will have videocapsule colonoscopy after bowel preparation, followed by standard colonoscopy the next day. Interventions:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PillCam Colon 2 | Device | PillCam® COLON 2 capsule endoscopy is a minimally invasive tool for direct visualization of the colon, including identifying the occurrence of polyps. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with full colonic exploration and detection of lesions | 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 | By the end of both procedures (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomosis visualization | Anastomosis visualization by VCC and type (latero-lateral, termino-lateral, latero-terminal and termino-terminal) | Prior to colonoscopy on Day 1 |
| Number and size of detected lesions |
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Inclusion Criteria:
Non-inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Delvaux, MD | Department of Hepato-Gastroenterology, Nouvel Hopital Civil, Strasbourg, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hepato-Gastroenterology, Nouvel Hopital Civil | Strasbourg | 67000 | France |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| Colonoscopy | Procedure | Standard colonoscopy is the standard against which capsule endoscopy is compared. |
|
Number and size of detected lesions with VCC compared to conventional colonoscopy
| By the end of both procedures (Day 1) |
| Quality of colic preparation | Assessment of the quality of colic preparation for VCC (D0) and colonoscopy (D1) | By the end of both procedures (Day 1) |
| Times related to videocapsule | Assessment of times related to videocapsule:
| Prior to colonoscopy on Day 1 |
| Adverse events related to VCC exam and colonoscopy | Assessment of safety of each method. Recording of adverse events. | Until end of Day 1 |
| Patient's assessment of tolerability and acceptance | Patient ranking of tolerability and acceptance of each of the procedures using a visual analog scale | Follow up visit (between Day 15 and Day 30) |
| Health-economic assessment | Assessment of costs associated to each of the exams:
| End of follow-up (between D15 and D30) |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |