Short summary

In an initial comparative trial of 250 individuals receiving Colon Capsule Endoscopy (CCE) and optical colonoscopy (OC), the results were that the CCE device was non-inferior to OC for the population that were exposed to both procedures and in whom both procedures were fully conducted. Unfortunately, in almost 50% of cases, the investigation by CCE was incomplete as the capsule was not excreted within its' battery lifetime. This latter finding is in contrast with other studies reported in the literature on CCE, in which excretion rates as high as 90.5 % have been presented in a meta-analysis.

The objective of the study is to establish which booster procedure best facilitates timely excretion of CCE. In addition, which booster procedure provides the highest level of bowel cleansing, alongside patient centered outcomes including satisfaction, compliance, and ability to manage CCE at home.

Rationale

At this point, it is not possible to know, why the excretion rates in the local population differed to such an extent to others' findings. One hypothesis is that the difference may be explained by the differences in bowel cleansing and boosting regimens. A screening population consists of healthy people per definition. Thus, the procedures they are exposed to in relation to their health has to entail a minimum of risk and thus, the bowel cleansing and boosting procedure used in Denmark consists of only Moviprep® and water. In other studies of CCE, the bowel cleansing and boosting procedures have varied, and the optimal method has yet to be determined.

Description of the cohort

Patients enrolled in a follow-up program due to previous colonic findings will be invited to participate. Furthermore, only patients that do not have the upcoming procedure as their final investigation will be invited to ensure that they are enrolled in future follow-up in addition to the current study. Patients are thus aware that they are enrolled in a follow-up programme and expect to be invited for a colonoscopy, with which they have previous experience.

Criteria for exclusion are:

• Hypersensitivity to the active substances or one or more of the subsidiary substances
• Gastrointestinal obstruction or perforation
• Previous problems with bowel cleansing
• Ileus
• Phenylketonuri (due to aspartam in Moviprep®)
• Glucose-6-phosphate-dehydrogenase deficiency (due to ascorbate in Moviprep®)
• Toxic megacolon, which complicates serious inflammatoric conditions in the intestinal canal including Morbus Crohn and colitis ulcerosa
• Serious kidney disease
• Previous surgery/resection of colon or rectum (except for appendectomy)
• Insulin-dependent Diabetes Mellitus
• Any implanted electronic devices including pacemakers
• Inability to sign informed consent
• Pregnancy

Data and biological material

Data include information on the capsule transit time, bowel cleanliness, and compliance. All data are collected in relation to the study and thus no additional databases will be used for further information.

Collaborating researchers and departments

Department of Surgery, Odense University Hospital, Svendborg

• Professor and consultant Gunnar Baatrup, MD
• PhD-student Rasmus Krøijer, MD
• Data manager Anne-Kirstine Dyrvig, MScPH