Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652906
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-11
Brief Title:
Study on the Safety and Efficacy of Sodium Phosphate Powder for Intestinal Preparation in People Aged 50 to 70 Years Old
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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 Fishers exact probability method for inter group comparison The inspection level is 005
Research period from April 2023 to August 2024
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 patients 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 Fishers exact probability method for inter group comparison The inspection level is 005
Research period from April 2023 to August 2024
Detailed Description:
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
1 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 15 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 30 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
After completing the intestinal preparation the renal function and electrolyte examination should be further improved followed by a colonoscopy examination Retain operation videos and if necessary take live tissue for inspection Efficacy evaluation Effectiveness evaluation indicators primary and secondary efficacy indicators
Main efficacy evaluation indicators
The effective rate of intestinal preparation that is the endoscopist determines that the patients 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
Secondary efficacy evaluation indicators
The effective rate of segmented intestinal preparation ie according to the Boston score for the 3 segments of the colon rectum sigmoid Colon transverse colon descending colon ascending colon cecum were scored separately
Polyp detection rate which is the ratio of patients with polyps detected by colonoscopy to the total number of patients
Adenoma detection rate refers to the ratio of patients with adenomas detected by colonoscopy to the total number of patients
Patient subjective tolerance score including taste score and willingness to repeat use score
Safety evaluation indicators The incidence of adverse reactions namely nausea vomiting abdominal pain and The proportion of patients with adverse reactions such as bloating and electrolyte imbalance to the total number of patients
Statistical methods Numerical variables are described using mean standard deviation Mean SD and estimated using normal distribution method Version number 30 Date December 5th 2023 three Calculate the 95 bilateral confidence interval of the overall mean and use t-test for inter group comparison Categorical variable Describe using frequency n and composition ratio ie n and estimate each using normal approximation method 95 confidence interval for the overall group rate using chi square test or Fishers exact probability method Compare between groups
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 Fishers exact probability method for inter group comparison The inspection level is 005
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
1 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 15 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 30 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
After completing the intestinal preparation the renal function and electrolyte examination should be further improved followed by a colonoscopy examination Retain operation videos and if necessary take live tissue for inspection Efficacy evaluation Effectiveness evaluation indicators primary and secondary efficacy indicators
Main efficacy evaluation indicators
The effective rate of intestinal preparation that is the endoscopist determines that the patients 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
Secondary efficacy evaluation indicators
The effective rate of segmented intestinal preparation ie according to the Boston score for the 3 segments of the colon rectum sigmoid Colon transverse colon descending colon ascending colon cecum were scored separately
Polyp detection rate which is the ratio of patients with polyps detected by colonoscopy to the total number of patients
Adenoma detection rate refers to the ratio of patients with adenomas detected by colonoscopy to the total number of patients
Patient subjective tolerance score including taste score and willingness to repeat use score
Safety evaluation indicators The incidence of adverse reactions namely nausea vomiting abdominal pain and The proportion of patients with adverse reactions such as bloating and electrolyte imbalance to the total number of patients
Statistical methods Numerical variables are described using mean standard deviation Mean SD and estimated using normal distribution method Version number 30 Date December 5th 2023 three Calculate the 95 bilateral confidence interval of the overall mean and use t-test for inter group comparison Categorical variable Describe using frequency n and composition ratio ie n and estimate each using normal approximation method 95 confidence interval for the overall group rate using chi square test or Fishers exact probability method Compare between groups
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 Fishers exact probability method for inter group comparison The inspection level is 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None