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Study on the Safety and Efficacy of Sodium Phosphate Powder for Intestinal Preparation in People Aged 50 to 70 Years Old

NCT06652906 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-10-22

No results posted yet for this study

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

Conditions

  • Physical Examination

Interventions

DRUG

Sodium phosphate powder

After admission, the patient underwent comprehensive renal function and electrolyte tests. The first medication was taken at 7pm the day before the examination. One bag of sodium phosphate powder was diluted with 800ml or more of warm and cool water before taking. The second dose of medication should be taken at 7am on the day of operation or examination (or at least 3 hours before the examination), with the same usage as the first dose, with a 12 hour interval between each dose. The standard dose for each dose is 1 bag, until clear water like stool appears.

DRUG

Polyethylene glycol electrolyte dispersion

After admission, the patient underwent comprehensive renal function and electrolyte examination. The evening before the intestinal examination, 2000ml of polyethylene glycol electrolyte San III isotonic solution was taken, 250ml every 10-15 minutes, and it was taken within 2 hours. On the day of examination, 2000ml of polyethylene glycol electrolyte San III isotonic solution was taken 3-4 hours in advance until clear water like stool appeared.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-11
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06652906 on ClinicalTrials.gov