Actively Recruiting
Study on the Safety and Efficacy of Sodium Phosphate Powder for Intestinal Preparation in People Aged 50 to 70 Years Old
Led by RenJi Hospital · Updated on 2024-10-22
8
Participants Needed
1
Research Sites
24 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study on the Safety and Efficacy of Sodium Phosphate Powder for Intestinal Preparation in People Aged 50 to 70 Years Old
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 70 years old, any gender
- No contraindications for colonoscopy and planning to undergo colonoscopy soon
- Willing to participate in this study
You will not qualify if you...
- History of colorectal surgery such as tumor removal or colorectal perforation
- Electrolyte disorders or currently on hemodialysis
- Active bleeding in the lower gastrointestinal tract
- Abnormal blood clotting function
- Severe diseases of lung, liver, kidney, or blood system, with liver or kidney test results exceeding 1.5 times the normal upper limit
- Other diseases that could affect treatment judgment or pose significant risks, including acute inflammatory bowel disease, colon cancer, intestinal obstruction, peritonitis, ascites, or severe constipation
- Mental illness or severe neurosis
- Known allergies to study drugs
- Participation in other clinical trials within the last month
- Any other condition deemed unsuitable for study inclusion or unwillingness to participate
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
P
Peng Yan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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