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
Not provided
Not provided
Several randomised studies have shown that the addition of low-dose Simethicone to the bowel preparation was sufficient to reduce the presence of bubbles during colonoscopy. The aim of this study was to evaluate the efficacy and safety of a bowel preparation containing low-dose Simethicone on bubble formation.
Patients and Methods This prospective, real-life, phase 4 study was conducted from February 2020 to May 2021, in five private endoscopy centres, among adult patients undergoing a colonoscopy. Clinical, endoscopic and histological parameters were collected on e-CRF. The primary endpoint was the measurement of bubble formation in the various colon segments.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simethicone combined with Macrogol 4000 (PEG) | Drug | bowel preparation product for colonoscopy as part of CRC screening |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the quality of the bowel preparation assessed by Bubble scale | During procedure | |
| Assess the quality of the bowel preparation assessed by Boston Bowel Preparation Scale (BBPS) | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Colonoscope removal time | time spent by the endoscopist searching for polyps and adenomas (mn) | immediately post procedure |
| The frequency of adverse events (AEs) | including nausea, vomiting, abdominal bloating - and their severity, |
Not provided
Inclusion Criteria:
patients :
Exclusion Criteria:
-
Not provided
Not provided
Not provided
All patients, scheduled for colonoscopy as part of CRC screening, were prospectively included according to the inclusion criteria
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique des Cèdres, Ramsay Santé, | Cornebarrieu | 31700 | France | |||
| Polyclinique Louis Pasteur, |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| within 10 minutes post procedure |
| volume of bowel preparation ingested | in ml | immediately post procedure |
| Caecal intubation rate | successful Caecal intubation | immediately post procedure. |
| Essey-lès-Nancy |
| 54280 |
| France |
| Saint Joseph Hospital | Marseille | 13008 | France |
| 5. Clinique Ambroise Paré | Toulouse | 31082 | France |
| Pole Santé des Haberges | Vesoul | 70000 | France |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided