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IRCT20211101052935N1 IRCT 2022-05-13 Shahid Beheshti University of Medical Sciences Investigating the effect of senna on preparation for colonoscopy Comparison of two bowel preparation regimens for colonoscopy: high-dose polyethylene glycol versus low-dose polyethylene glycol combined with senna 2021-02-28 anticipated 362 Complete https://irct.ir/trial/59743 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Based on sample size of study, 100 blocks with a size of 4 (such as AABB, ABAB, etc.) in a randomly varied order, will be used for random allocation. Random blocks will be provided by GraphPad software. The blocks will be placed one after the other in sequence, from the first to the 100th of them (equivalent to the first to the 400th patient). For example, if the blocks that will be provided by the software are AABB, BBAA, ABAB, respectively, the order of patients’ bowel preparation regimens will be AABBABABBBAA. The order of the blocks (100 provided blocks, it means arranging 400 bowel preparation regimens for 400 patients) will be reposed to the clinic secretary. Patients who will be candidates for colonoscopy, do not meet the exclusion criteria, and declare their informed consent to enter the study, will receive a preparation regimen based on the provided blocks A or B, respectively, Blinding description: The endoscopist does not know which class of medications had been used by the patient for preparation. Therefore, he/she reports the patient's preparation in the colonoscopy report, regardless of the preparation regimen. 3 colonoscopy preparation. Intervention 1: Control group: In this study, all patients will undergo colonoscopy in the afternoon and we will use a split-dose preparation, i.e., administering half of the colon cleansing agent in the evening (4 pm) before colonoscopy and the remaining in the morning (Five hours before the procedure). Patients in the control group will receive 6 sachets of polyethylene glycol powder (420 g) (Sepidaj Pharmaceutical Company), at 4 pm on the prior day of colonoscopy to 5 hours before the procedure. Intervention 2: Intervention group: In this study, all patients will undergo colonoscopy in the afternoon and we will use a split-dose preparation, i.e., administering half of the colon cleansing agent in the evening (4 pm) before colonoscopy and the remaining in the morning (Five hours before the procedure). Patients in the intervention group will receive 3 sachets of polyethylene glycol powder (210 g) (Sepidaj Pharmaceutical Company), along with senna solution (120 ml) (Iran Darok Company) in two divided doses of 60 ml. The first dose will be given at 4 pm on the prior day of the colonoscopy and the second dose on the morning of the procedure (five hours before the procedure). No - There is not a plan to make this available Justification or reason for not sharing IPD is No further information available.
public Mohsen Rajabnia
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2243 2560 dr.rajabnia@outlook.com Shahid Beheshti University of Medical Sciences scientific Amir Sadeghi
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2243 2560 amirsadeghimd@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) People more than 18 year-old. Giving a written consent. Indications for colorectal cancer screening, include: average-risk screening, increased-risk screening (patients with one or more first degree relative[s] with colorectal cancer [CRC] or colorectal adenomas, hereditary CRC syndromes), positive fecal occult blood test, documented iron deficiency anemia in men or postmenopausal women. Lower gastrointestinal symptoms such as unexplained chronic clinically significant diarrhea, or unexplained involuntary weight loss. Abnormal abdominal imaging such as abnormalities detected on barium enema, abdominal computed tomography and etc. 18 years no limit Both Hypersensitivity to polyethylene glycol or senna Taking laxatives within one week prior to colonoscopy Previous colonic resection surgery Known or suspected bowel obstruction Prior history of colonoscopy Other Other Control group: In this study, all patients will undergo colonoscopy in the afternoon and we will use a split-dose preparation, i.e., administering half of the colon cleansing agent in the evening (4 pm) before colonoscopy and the remaining in the morning (Five hours before the procedure). Patients in the control group will receive 6 sachets of polyethylene glycol powder (420 g) (Sepidaj Pharmaceutical Company), at 4 pm on the prior day of colonoscopy to 5 hours before the procedure. Intervention group: In this study, all patients will undergo colonoscopy in the afternoon and we will use a split-dose preparation, i.e., administering half of the colon cleansing agent in the evening (4 pm) before colonoscopy and the remaining in the morning (Five hours before the procedure). Patients in the intervention group will receive 3 sachets of polyethylene glycol powder (210 g) (Sepidaj Pharmaceutical Company), along with senna solution (120 ml) (Iran Darok Company) in two divided doses of 60 ml. The first dose will be given at 4 pm on the prior day of the colonoscopy and the second dose on the morning of the procedure (five hours before the procedure). Quality of colon preparation. Timepoint: During colonoscopy (within first 24 hours after use regimens). Method of measurement: Endoscopist report based on BBPS (Boston Bowel Preparation Scale). Adverse effects of preparation regimens. Timepoint: While taking the drug until colonoscopy. Method of measurement: patients report. Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences Approved 2021-02-24 Gastroenterology and Liver Diseases Research Institute, Shahid Beheshti University of Medical Scienc Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran. Tehran Tehran Iran (Islamic Republic of)