AIM: To evaluate the possibility of reducing the volume of polyethylene glycol (PEG)-electrolyte solution using adjunctive mosapride citrate for colonoscopy preparation. METHODS: This was a single-center, prospective, randomized, investigator-blinded, non-inferiority study involving 252 patients of both sexes, aged from 20 to 80 years, scheduled for screening or diagnostic colonoscopy in our department. A total of 126 patients was randomized to receive 1.5 L PEG-electrolyte solution plus 15 mg of mosapride (1.5 L group), and 126 received 2 L PEG-electrolyte solution plus 15 mg of mosapride (2 L group). Patients completed a questionnaire on the acceptability and tolerability of the bowel preparation process. The efficacy of bowel preparation was assessed using a 5-point scale based on the Aronchick scale. The primary end point was adequate bowel preparation rates (score of excellent/good/fair) vs (poor/inadequate). Acceptability and tolerability, as well as disease detection, were secondary end points. RESULTS: A total of 244 patients was included in the analysis. There were no significant differences between the 2 L and 1.5 L groups in age, sex, body mass index, number of previous colonoscopies, and the preparation method used previously. The adequate bowel preparation rates were 88.5% in the 2 L group and 82.8% in the 1.5 L group [95% lower confidence limit (LCL) for the difference = -14.5%, non-inferiority P = 0.019] in the right colon. In the left colon, the adequate bowel preparation rates were 89.3% in the 2 L group and 81.1% in the 1.5 L group (95% LCL = -17.0%, non-inferiority P = 0.066). Compliance, defined as complete (100%) intake of the PEG solution, was significantly higher in the 1.5 L group than in the 2 L group (96.8% vs 85.7%, P = 0.002). The proportion of abdominal distension (none/mild/moderate/severe) was significantly lower in the 1.5 L group than in the 2 L group (36/65/22/3 vs 58/48/18/2, P = 0.040). Within the subgroup who had undergone colonoscopy previously, a significantly higher number of patients in the 1.5 L group than in the 2 L group felt that the current preparation was easier than the previous one (54.1% vs 28.0%, P = 0.001). The disease detection rate was not significantly different between the two groups. CONCLUSION: Although the 1.5 L group had better acceptability and tolerability, 15 mg of mosapride may be insufficient to compensate for a 0.5-L reduction of PEG solution.
RCT Entities:
AIM: To evaluate the possibility of reducing the volume of polyethylene glycol (PEG)-electrolyte solution using adjunctive mosapride citrate for colonoscopy preparation. METHODS: This was a single-center, prospective, randomized, investigator-blinded, non-inferiority study involving 252 patients of both sexes, aged from 20 to 80 years, scheduled for screening or diagnostic colonoscopy in our department. A total of 126 patients was randomized to receive 1.5 L PEG-electrolyte solution plus 15 mg of mosapride (1.5 L group), and 126 received 2 L PEG-electrolyte solution plus 15 mg of mosapride (2 L group). Patients completed a questionnaire on the acceptability and tolerability of the bowel preparation process. The efficacy of bowel preparation was assessed using a 5-point scale based on the Aronchick scale. The primary end point was adequate bowel preparation rates (score of excellent/good/fair) vs (poor/inadequate). Acceptability and tolerability, as well as disease detection, were secondary end points. RESULTS: A total of 244 patients was included in the analysis. There were no significant differences between the 2 L and 1.5 L groups in age, sex, body mass index, number of previous colonoscopies, and the preparation method used previously. The adequate bowel preparation rates were 88.5% in the 2 L group and 82.8% in the 1.5 L group [95% lower confidence limit (LCL) for the difference = -14.5%, non-inferiority P = 0.019] in the right colon. In the left colon, the adequate bowel preparation rates were 89.3% in the 2 L group and 81.1% in the 1.5 L group (95% LCL = -17.0%, non-inferiority P = 0.066). Compliance, defined as complete (100%) intake of the PEG solution, was significantly higher in the 1.5 L group than in the 2 L group (96.8% vs 85.7%, P = 0.002). The proportion of abdominal distension (none/mild/moderate/severe) was significantly lower in the 1.5 L group than in the 2 L group (36/65/22/3 vs 58/48/18/2, P = 0.040). Within the subgroup who had undergone colonoscopy previously, a significantly higher number of patients in the 1.5 L group than in the 2 L group felt that the current preparation was easier than the previous one (54.1% vs 28.0%, P = 0.001). The disease detection rate was not significantly different between the two groups. CONCLUSION: Although the 1.5 L group had better acceptability and tolerability, 15 mg of mosapride may be insufficient to compensate for a 0.5-L reduction of PEG solution.
Authors: V K Sharma; S K Chockalingham; E A Ugheoke; A Kapur; P H Ling; R Vasudeva; C W Howden Journal: Gastrointest Endosc Date: 1998-02 Impact factor: 9.427
Authors: Jin Lee; Su Jin Jeong; Tae Hyung Kim; Yong Eun Park; Joon Hyuk Choi; Nae-Yun Heo; Jongha Park; Seung Ha Park; Young Soo Moon; Tae Oh Kim Journal: Medicine (Baltimore) Date: 2020-01 Impact factor: 1.817