Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Following European guidelines patients undergoing colonoscopy in one of Odense University Hospitals units will now be offered a colon capsule endoscopy (CCE) in case of incomplete examinations. Patients formerly referred to colonoscopy in general anesthesia or patients who decline colonoscopy after having completed bowel preparation will also be offered a CCE. In our department we have conducted a comparison study documenting that the sensitivity of CCE is superior to CT colonography in both polyps >9 mm and polyps >5 mm, which is also supported by an Italian study. The safety and completion rate of CCE following incomplete colonoscopy is confirmed by several studies including one multicenter study and the completion rate is not significantly lower compared to other patient groups. In an incomplete colonoscopy it is always the most oral part of the colon which is not visualized, whereas in CCE, an incomplete investigation will most often have visualized the oral part. By combining incomplete colonoscopy results and incomplete CCE results we can identify patients who have had a complete colon investigation although both investigations were incomplete.
Aim: to investigate the quality of CCE and the completion rate in patients who have undergone an incomplete colonoscopy, have completed bowel preparation but declines colonoscopy or have been referred to colonoscopy in general anesthesia.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incomplete colonoscopy | Individuals referred to colon capsule endoscopy due to incomplete colonoscopy investigation. |
| |
| Colonoscopy general anesthesia | Individuals referred to colon capsule endoscopy as alternative to colonoscopy under general anesthesia. |
| |
| Colonoscopy declined | Individuals referred to colon capsule endoscopy after completion of bowel preparation for colonoscopy, but who have declined colonoscopy to be carried out. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colon capsule endoscopy | Device | Endoscopy performed using PillCam2 camera capsule for oral ingestion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete mucosal visualization combining incomplete investigations | By combining results from incomplete colon capsule endoscopy and incomplete colonoscopy we will identify complete combined investigations. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Completion rate of colon capsule endoscopy | Total and subgroup completion rates of investigations | 2 years |
| Safety of colon capsule endoscopy | Total and subgroup safety of investigations |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All adults referred to colon capsule endoscopy from the surgical department of Odense University Hospital, which signs consent form enabling us to retrieve personal data.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gunnar Baatrup, Prof. | Contact | +4520575154 | gunnar.baatrup@rsyd.dk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Recruiting | Svendborg | 5700 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36471059 | Derived | Havshoi AV, Deding U, Jensen SS, Andersen PV, Kaalby L, Al-Najami I. Colon capsule endoscopy following incomplete colonoscopy in routine clinical settings. Surg Endosc. 2023 Apr;37(4):2749-2755. doi: 10.1007/s00464-022-09783-w. Epub 2022 Dec 5. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 year |
| Quality of colon capsule endoscopy | Sensitivity and specificity compared to colonoscopies | 1 year |
| Economic evaluation | Economic analyses and evaluations comparing cost of investigations per patient and per case by investigation type. | 1 year |
| Patient preference | Investigation of patient preferences stratified by demographic characteristics and history of endoscopic procedures | 2 years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013514 | Surgical Procedures, Operative |