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IRCT20110721007080N5 IRCT 2020-05-04 Babol University of Medical Sciences Evaluation of the effect of patient position change on the quality of colonoscopy Evaluation of the Effectiveness of changing patient's position during the Withdrawal phase of Colonoscopy from left lateral Decubitus to Supine on increasing Adenoma Detection Rate (ADR) 2020-04-20 anticipated 624 Complete https://irct.ir/trial/46565 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Patients will assign to study groups due to the random blocks method. By using a website(www.randomization.com) and considering one block and total sample size 624, all patients with a 1 to 1 ratio, randomly assigned to one of the study groups according to the patient's number. During the colonoscopy, at the beginning of the withdrawal phase, the physician will use the patient's list and put a patient in a considered group according to patient's number and continue the procedure, Blinding description: This study is a single-blind study. Due to anesthesia, the patients are blind to the group they are in. The physician performing the colonoscopy is blind to the patient group up to the beginning of the withdrawal phase of colonoscopy, but because of the nature of the colonoscopy process and the physician's direct view of how the patient is positioned, it is not possible to blind the physician during the withdrawal phase of colonoscopy. N/A Adenoma Detection Rate (ADR). Intervention 1: Intervention group: positioning the patient in supine position in the withdrawal phase of colonoscopy. At the beginning of the withdrawal phase of colonoscopy, patients will be switched from the left lateral position to the supine position by helping from the nurse, and the physician initiates the withdrawal phase of colonoscopy. Intervention 2: Control group: positioning the patient in the left lateral decubitus position in the withdrawal phase of colonoscopy. Patients will remain in the same position lying on their left side and the doctor will initiate the withdrawal phase of colonoscopy. Yes - There is a plan to make this available What will be shared: Epidemiological findings and gathered data from colonoscopy and pathology results after making participants anonymous are sharable. When: The start of access is 6 months after the publication of results. To whom: The data are accessible to other scientists. Conditions: The researcher must say the data are used in which research and specify the goal of the research. Where to obtain: For data access refer to the corresponding author. How to obtain: Request for data access is sent to the corresponding author and after investigation, if seeming fit, the data will be shared Comments:
public Javad Shokri Shirvani
Rouhani haspital, Danesgah Square, Ganjafrooz Avenue, Babol
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 1223 8284 drshokrij@mubabol.ac.ir Babol University of Medical Sciences scientific Javad Shokri Shirvani
Rouhani haspital, Danesgah Square, Ganjafrooz Avenue, Babol
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 1223 8284 drshokrij@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age between 40 and 85 years Recommended to do screening colonoscopy 40 years 85 years Both History of Colitis History of Colonic Polyposis Syndrome Familial history of Colorectal Cancer History of Colectomy History of Cholecystectomy History of Endoscopic Retrograde Cholangiopancreatography (ERCP) History of Colonoscopy in the past year History of Inflammatory Bowel Disease History of Opium use Lack of Anesthesia for Colonoscopy Difference in received Anesthesia Drug Lack of Antispasmodic Medication for Colonoscopy Differences in received Antispasmodic Drug Difference in dose of received Antispasmodic Drug Absence of a Nurse during Colonoscopy Presence of a second physician during Colonoscopy Musculoskeletal problems in Patient Patient Dissatisfaction to Participate in the Study Disapproval of reaching to Cecum by physician or requiring more than 20 minutes to reach the Cecum Inadequate Bowel Preparation (The Boston Bowel Preparation Scale less than 5) Occurrence of any Side Effects During the Colonoscopy procedure K63.5 Polyp of colon Diagnosis Diagnosis Intervention group: positioning the patient in supine position in the withdrawal phase of colonoscopy. At the beginning of the withdrawal phase of colonoscopy, patients will be switched from the left lateral position to the supine position by helping from the nurse, and the physician initiates the withdrawal phase of colonoscopy. Control group: positioning the patient in the left lateral decubitus position in the withdrawal phase of colonoscopy. Patients will remain in the same position lying on their left side and the doctor will initiate the withdrawal phase of colonoscopy. Adenoma Detection Rate. Timepoint: The outcome variable will be calculated after doing colonoscopy for all specimens for both study groups. Method of measurement: The number of adenomas observed in the withdrawal phase for each patient will be recorded in the patient's pre-prepared form. After doing colonoscopy of all specimens, we calculate the adenoma detection rate for each group. It is the proportion of patients in whom more than one adenoma has been observed to all patients undergoing colonoscopy and will be calculated separately for each group. The Size of a Detected lesion. Timepoint: During Colonoscopy Procedure. Method of measurement: during the colonoscopy procedure, the diameter of the detected lesion will be measured in comparison to the biopsy forceps and will be recorded in the patient-specific form. Patient's feeling about Abdominal Fullness after Colonoscopy. Timepoint: 10 minutes after the patient recovered. Method of measurement: 10 minutes after the patient recovered, we will ask him or her about abdominal fullness by using a prepared question which has 5 option from no abdominal fullness to painful fullness. Babol University of Medical Sciences Approved 2020-03-14 Research Ethics Committee of Health Research Institute - Babol University of Medical Sciences Ganj Afroz St, Babol University of Medical Sciences, Health Research Institute Babol Mazandaran Iran (Islamic Republic of)