Clinical trial · Interventional
Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery
NCT01879943CI-TRIAL-00038061terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Operational difficulties related to medical staff turnover (investigators departure and sickness leave).
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy | Procedure | — | UNRESOLVED |
| PillCam Colon 2 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PillCam COLON 2 and Standard Colonoscopy
- description
- 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
- interventionNames
- Device: PillCam Colon 2
- Procedure: Colonoscopy
Primary outcomes (1)
- measure
- Number of patients with full colonic exploration and detection of lesions
- timeFrame
- By the end of both procedures (Day 1)
- description
- 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
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. patient between 18 and 85 years old 2. patient with greater than 3 month follow-up for colorectal resection with ileo-colic , colo-colic or colorectal anastomosis, regardless of etiology 3. patient requiring a colonoscopy for regular medical care 4. absence of contra-indication to anesthesia and to colonoscopy conduct 5. patient able to understand the study related information and to provide written informed consent 6. patient registered with the French social security regime Non-inclusion Criteria: 1. absence of written informed consent 2. patient having had a total colectomy 3. patient with terminal stoma 4. patient with clinical suspicion of intestinal stenosis and/or anastomotic stenosis 5. patient with known Zenker diverticulum 6. patient wearing a pacemaker or any other internal electronic medical device 7. patient with deglutition disorders and/or altered state of consciousness 8. patient with serious disease preventing planned study procedures 9. pregnant or breast-feeding woman 10. patient within exclusion period from other clinical trial 11. patient having forfeited their freedom of an administrative or legal obligation 12. patient being under guardianship
References
Publications (0)
Data not yet available
No reference posted for this study.