A Prospective, Multicenter, Randomized Controlled Clinical Trial on the Safety and Efficacy of Sodium Phosphate Powder for Intestinal Preparation in the Population Aged 50 to 70 Years Old

Project Name: Safety and Efficacy of Sodium Phosphate Powder for Intestinal Preparation in People Aged 50 to 70: A Study Prospective, multicenter, randomized controlled clinical trials 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 years old Completeness. 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.

Case selection Inclusion Criteria

1. Age range from 50 to 70 years old, regardless of gender;

2. No contraindications for colonoscopy examination, plan to undergo colonoscopy examination in the near future;

3. Agree to participate in this study. Exclusion criteria

4. Patients with a history of colorectal surgery (resection of malignant tumors, resection of colorectal perforation, etc.); 2. Electrolyte disorders and hemodialysis patients; 3. Patients with active lower gastrointestinal bleeding; 4. Patients with abnormal coagulation function; 5. Concomitant severe primary diseases such as lung, liver, kidney, and hematopoietic system, liver function ALT AST Exceeding the upper limit of the reference value by 1.5 times, or Cr exceeding the upper limit of the reference value; 6. Merge other diseases that may affect the efficacy judgment or pose a significant risk, such as inflammatory bowel disease Acute phase, colon cancer, intussusception, volvulus, intestinal obstruction, peritonitis, ascites, refractory Constipation, etc; 7. Patients with mental illness and severe neurosis; 8. Patients who are known to have allergies to the investigational or control drugs; 9. Those who have participated in other clinical studies within one month; 10. Researchers believe that there are other situations that are not suitable for inclusion, and patients are unwilling to be included in the study.

Version number: 3.0 Date: December 5th, 2023 two Treatment plan: Sodium phosphate powder group: Patients will receive comprehensive renal function and electrolyte tests after admission, and will take medication for the first time At 7pm the day before the inspection, 1 bag of sodium phosphate powder should be diluted with 800ml or more of warm and cool boiled water Take after release. The second medication should be taken at 7am on the day of operation or examination (or before the examination) Less than 3 hours), the usage is the same as the first time, with a 12 hour interval between each session. The standard dose for each session is 1 bag, Until clear water like stool appears, the patient should take a photo of their intestines to prepare for feces, and record the results of each dose taken The time of the first and last bowel movements, as well as the frequency of each bowel movement. After the intestinal preparation is completed, Further improvement of renal function and electrolyte examination, followed by colonoscopy examination and retention of operation video, necessary Take live tissue for examination when necessary. Fujingqing group: After admission, patients were given comprehensive renal function and electrolyte tests, and the day before intestinal examination Take 2000ml of polyethylene glycol electrolyte powder III isotonic solution at night, every 10-15 minutes 250ml, taken within 2 hours, take polyethylene glycol electrolyte powder III 3-4 hours in advance on the day of examination 2000ml of isotonic solution until clear water like stool appears, and the patient should take a photo of the intestine to prepare the stool, Record the time of the first and last bowel movements, as well as the frequency of bowel movements, after each dose of medication.