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IRCT20140203016473N9 IRCT 2018-05-12 Tabriz University of Medical Sciences The effects of perioperative probiotic treatment after colorectal surgery The effects of perioperative probiotic treatment on postoperative complications after colorectal surgery-a randomized clinical trial 2018-03-21 anticipated 120 Complete https://irct.ir/trial/30514 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomized between two study (who will receive the probiotic) and control (who will not receive the probiotic) groups by the random numbers produced by the website: www.randomizer.org. 3 Condition 1: Malignant diseases of colon. Condition 2: Benign diseases of the colon, rectum, anus and anal canal. Condition 3: Foreign body in colon. Condition 4: Other specified diseases of intestine. Intervention 1: Intervention group: Pre- and postoperative treatment by oral probiotic drug after colorectal surgery. Intervention 2: Control group: Routine pre- and postoperative treatment of colorectal surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more data now.
public Farzad Kakaei
Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614695 +98 41 3334 1317 fkakaei@yahoo.com Tabriz University of Medical Sciences scientific Farzad Kakaei
Golgasht Street
Tabriz Iran (Islamic Republic of) 5166614695 +98 41 1334 1317 Fkakaei@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Need for any elective colorectal surgery Nurgery is done by an attending surgeon Good nutritional status 18 years 80 years Both No consent to enter the study Small or large bowel obstruction Anticoagulant consumption ASA class IV Inflammatory bowel disease History of chemotherapy Transplant recipients Liver cirrhosis Antibiotic consumption in the week before surgery Steroid consumption Diabetes mellitus Pregnancy or breastfeeding Immunodeficiency of any cause C18 D12 T18.4XXA K63.8 Malignant neoplasm of colon Benign neoplasm of colon, rectum, anus and anal canal Foreign body in colon, initial encounter Other specified diseases of intestine Treatment - Drugs Treatment - Drugs Intervention group: Pre- and postoperative treatment by oral probiotic drug after colorectal surgery Control group: Routine pre- and postoperative treatment of colorectal surgery Anastomosis rupture. Timepoint: Daily till 30 days after the operation. Method of measurement: Physical examination. Surgical site infection. Timepoint: Daily till 30 days after the operation. Method of measurement: Physical examination. Fascia dehiscence. Timepoint: Daily till 30 days after the operation. Method of measurement: Physical examination. Pulmonary infection. Timepoint: Daily till 30 days after the operation. Method of measurement: Chest x-ray if clinically indicated. Urinary infection. Timepoint: Daily till 30 days after the operation. Method of measurement: Urinalysis if clinically indicated. Total duration of hospital stay. Timepoint: Daily. Method of measurement: Total duration of hospital stay till discharge. Mortality. Timepoint: Daily. Method of measurement: Report of death by attending physician. Tabriz University of Medical Sciences Approved 2018-03-12 Ethics committee of Tabriz University of medical sciences Azadi Ave, Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)