Zhuan Liao1, Zhao-Shen Li, Can Xu. 1. Digestive Endoscopy Center, Department of Gastroenterology, Changhai Hospital, The Second Military Medical University, Shanghai, China. zhuanliao@hotmail.com
Abstract
BACKGROUND: A capsule endoscope failed to reach the cecum in approximately 20% of cases, with delayed gastric emptying being the most common cause. We hypothesized that reduction of the capture rate in the stomach saves the battery life and thus allows the capsule endoscope to reach the cecum. OBJECTIVE: The aim of this study was to determine whether reduction of the capture rate of a capsule endoscope in the stomach increases the complete examination rate (CER). SETTING:An endoscopy center in a teaching hospital in Shanghai. DESIGN: A prospective randomized controlled trial. PATIENTS: A total of 50 patients were prospectively randomized into 2 groups: modified capture rate (MCR) group (n = 25) and the control group (n = 25). INTERVENTIONS: The OMOM capsule endoscopy system, which has the functions of viewing images in real time and modifying the capture rate during the examination, was used. In patients in the MCR group, the capture rate of the capsule endoscope was initially set at 0.5 frames per second (fps) and then was modified to 2 fps once the capsule endoscope passed the pylorus; whereas, in patients in the control group, the capture rate of the capsule endoscope was set and kept at 2 fps during the entire recording. MAIN OUTCOME MEASUREMENTS: The primary outcome was CER, and the secondary outcome was the total work time of the capsule. RESULTS: There was no significant difference in sex distribution, mean age, the number of hospitalized patients, and indications between the 2 groups. The CER was significantly higher in the MCR group than in the control group (100% vs 72%, respectively; P = .014). The mean (SD) total work time was much longer in the MCR group than in the control group (650 [145] minutes vs 439 [69] minutes, P < .001). There were no significant differences in gastric transit time, colon imaging time, and the diagnostic yield between the 2 groups. LIMITATIONS: The sample size was small, although statistical significance of the primary outcome was achieved. However, this could have limited representativeness. CONCLUSIONS: Reduction of the capture rate of the OMOM capsule endoscope in the stomach increased the complete small-bowel examination rate, although the diagnostic yield was not increased in our patient setting.
RCT Entities:
BACKGROUND: A capsule endoscope failed to reach the cecum in approximately 20% of cases, with delayed gastric emptying being the most common cause. We hypothesized that reduction of the capture rate in the stomach saves the battery life and thus allows the capsule endoscope to reach the cecum. OBJECTIVE: The aim of this study was to determine whether reduction of the capture rate of a capsule endoscope in the stomach increases the complete examination rate (CER). SETTING: An endoscopy center in a teaching hospital in Shanghai. DESIGN: A prospective randomized controlled trial. PATIENTS: A total of 50 patients were prospectively randomized into 2 groups: modified capture rate (MCR) group (n = 25) and the control group (n = 25). INTERVENTIONS: The OMOM capsule endoscopy system, which has the functions of viewing images in real time and modifying the capture rate during the examination, was used. In patients in the MCR group, the capture rate of the capsule endoscope was initially set at 0.5 frames per second (fps) and then was modified to 2 fps once the capsule endoscope passed the pylorus; whereas, in patients in the control group, the capture rate of the capsule endoscope was set and kept at 2 fps during the entire recording. MAIN OUTCOME MEASUREMENTS: The primary outcome was CER, and the secondary outcome was the total work time of the capsule. RESULTS: There was no significant difference in sex distribution, mean age, the number of hospitalized patients, and indications between the 2 groups. The CER was significantly higher in the MCR group than in the control group (100% vs 72%, respectively; P = .014). The mean (SD) total work time was much longer in the MCR group than in the control group (650 [145] minutes vs 439 [69] minutes, P < .001). There were no significant differences in gastric transit time, colon imaging time, and the diagnostic yield between the 2 groups. LIMITATIONS: The sample size was small, although statistical significance of the primary outcome was achieved. However, this could have limited representativeness. CONCLUSIONS: Reduction of the capture rate of the OMOM capsule endoscope in the stomach increased the complete small-bowel examination rate, although the diagnostic yield was not increased in our patient setting.