Study on the Safety and Efficacy of Sodium Phosphate Powder for Intestinal Preparation in People Aged 50 to 70 Years Old
Status:
RECRUITING
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
Project Name: Safety and Efficacy of Sodium Phosphate Powder for Intestinal Preparation in People Aged 50 to 70: A Prospective, Multicenter, Randomized Controlled Clinical Trial The main purpose of the study is to investigate the effectiveness and safety of sodium phosphate powder for intestinal preparation in people aged 50 to 70.
Secondary objective: To study the tolerance of sodium phosphate powder for intestinal preparation in the population aged 50 to 70 years and its impact on The impact of lesion detection. A prospective multicenter intervention randomized controlled clinical study of research design The total number of cases is 362 in the group leader center, with a total of 8 participating centers each having 44 cases.
Treatment plan: Sodium phosphate powder group or Fujingqing group
Main efficacy evaluation indicators:
The effective rate of intestinal preparation, that is, the endoscopist determines that the patient's Boston intestinal preparation score is 6 points and The ratio of patients with a bowel preparation score of 2 points per segment to the total number of patients.
Safety evaluation indicators Adverse reaction incidence rate Statistical methods: Numerical variables are described using mean standard deviation (Mean SD) and estimated using normal distribution method
Analysis of main efficacy indicators:
Based on the intention to treat set, including all qualified patients undergoing colonoscopy, efficacy evaluation will be conducted, Use chi square test or Fisher's exact probability method for inter group comparison. The inspection level is 0.05.
Research period from April 2023 to August 2024