Effective method of intestinal preparation in patients undergoing colonoscopy referred to Shahid Beheshti Hospital in Qom
Design
A clinical trial study include control group and four intervention groups (70 participant in each group) is selected by the available sampling method. By analyzing the use of opaque envelopes sealed with random sequence (SNOSE) will be performed by the analyzer itself.
Settings and conduct
Peg powder at the time of consumption than from 10 am the day before colonoscopy at intervals of one hour so that the last glass at 1 o'clock in the morning of the colonoscopy (in 3 divided doses with an interval of 8 hours Peg), the second tablet at 5 pm the day before Patients will be given a colonoscopy and a third pill at 1 a.m. on the day of the colonoscopy. Colonoscopy will be performed between 9 am and 1 pm by a gastroenterologist (to standardize the examination method) using a colonoscope for 15 to 30 minutes with the administration of painkillers and sedatives and local anesthesia by an anesthesiologist.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients aged 18 years and older;
Outpatients.
Exclusion criteria:
inflammatory bowel disease;
intestinal obstruction;
perforation;
lung, heart disease;
severe nausea;
Patients with loss of consciousness and swallowing disorders; Patients with ileostomy; Patients with a history of drug allergy
Intervention groups
High volume pack - 4 liters; High volume pack + 3 tablets of metoclopramide 10mg; High volume pack + 3 tablets of metoclopramide 400mg + erythromycin 3 tablets of 400 mg; High volume pack + 3 tablets of metoclopramide 10mg + erythromycin 3 tablets of 400 mg; Low volume pack + 3 tablets of metoclopramide 10mg + erythromycin 3 tablets of 400 mg
Main outcome variables
Determining colon preparation quality؛
cecum intubation mean time؛
polyp detection frequency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210719051943N1
Registration date:2022-01-22, 1400/11/02
Registration timing:prospective
Last update:2022-01-22, 1400/11/02
Update count:0
Registration date
2022-01-22, 1400/11/02
Registrant information
Name
mehdi pezeshki modares
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2000
Email address
mpezeshkim@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of adding erythromycin and metoclopramide to the standard diet of colonoscopy in colonoscopy preparation
Public title
adding erythromycin and metoclopramide to the diet of colonoscopy preparation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 years and older
Outpatients
Exclusion criteria:
Intestinal inflammation
Cardiopulmonary diseases
severe nausea
patients with decreased consciousness
Patients with a history of drug allergy
Intestinal perforation
Intestinal obstruction
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
350
Randomization (investigator's opinion)
Randomized
Randomization description
A stochastic sequence will be generated by the block analytics method using a limited block randomization method. Random allocation encryption will be performed by the analyzer itself using the method of using opaque sealed
envelopes sealed with random sequence (SNOSE). Participants will attend the study over time and on a random. interventionism and control groups will be assigned based on accident (coin toss).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of qom University of Medical Sciences
Street address
Beheshti Blv
City
Qom
Province
Ghoum
Postal code
3719964797
Approval date
2021-05-02, 1400/02/12
Ethics committee reference number
IR. MUQ .REC.1400.017
Health conditions studied
1
Description of health condition studied
Colonoscopic preparation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determining colon preparation quality
Timepoint
All colonoscopies will be performed in the period from 9 am to 1 pm by a gastroenterologist (to standardize the examination method). This may take between 15 and 30 minutes per person. clinical outcome assessed with colonoscopist during the procedure
Method of measurement
questionnaire
2
Description
cecum intubation mean time
Timepoint
All colonoscopies will be performed in the period from 9 am to 1 pm by a gastroenterologist (to standardize the examination method). This may take between 15 and 30 minutes per person. clinical outcome assessed with colonoscopist during the procedure
Method of measurement
questionnaire
3
Description
polyp detection frequency
Timepoint
All colonoscopies will be performed in the period from 9 am to 1 pm by a gastroenterologist (to standardize the examination method). This may take between 15 and 30 minutes per person. clinical outcome assessed with colonoscopist during the procedure