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IRCT20210804052083N1 IRCT 2022-04-10 Bandare-abbas University of Medical Sciences Evaluation of the effect of synbiotic on complications after gastrointestinal surgery Evaluation of the effect of synbiotic on complications after gastrointestinal surgery - randomized clinical trial 2022-03-21 anticipated 40 Complete https://irct.ir/trial/57970 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before assigning groups to individuals eligible to participate in the study, informed consent is completed for grouping individuals. the person who has no role in admitting patients and assigning patients to random codes preparing random sequences using online tools (https://www.sealedenvelope.com/) and by permuted block randomization method. Individualized random allocation is done in blocks with sizes 2 and 4, and without stratification. eligibility criteria are monitored by the person responsible for admitting patients. Codes in a random sequence are assigned to patients by the treatment team without knowing that each code is in the intervention or placebo group. Patient codes are then matched to randomly generated sequence information for interventions. (randomization concealment is done by the treatment team without informing the person responsible for admitting patients and the person who prepared the random sequence.), Blinding description: In this study, all participants are aware of participating in this study and enter the study with their consent. All participants are unaware of which group of this study they are in and after grouping patients in the groups, Patients receive synbiotic in the treatment group and receive a placebo in the control group. The lead researcher, health care personnel, data collection officials are aware of the grouping of patients. Those who prepare the draft of the article are unaware of the groupings if they do not cooperate in the above cases. The outcome assessor physician will be unaware of the patient's allocation. 3 Condition 1: Benign neoplasms of the large intestine, rectum, anus and anal canal. Condition 2: Benign neoplasms of other parts and obscure parts of the gastrointestinal tract. Condition 3: Malignant mesothelial and soft tissue neoplasms. Condition 4: Carcinoma in situ of other gastrointestinal organs and unspecified gastrointestinal organs. Condition 5: Carcinoma in situ of oral cavity, oesophagus and stomach. Condition 6: Benign carcinoma of the colon, rectum, anus, and anal canal. Condition 7: Neoplasms with indeterminate or unspecified behavior of the oral cavity and gastrointestinal tract. Condition 8: Malignant neoplasms of the liver and intrahepatic bile ducts. Condition 9: Malignant gallbladder neoplasm. Condition 10: Malignant neoplasms of other unknown parts of the bile duct. Intervention 1: Group A: In the intervention group, patients will receive lactocare capsules 500mg (zist takhmir pharmaceutical company) 7 days before surgery and as soon as they start oral administration after surgery until their discharge or for a maximum of one week. The drug will be prescribed twice a day after meals and oral or intravenous antibiotics should not be taken for at least 2 hours. Intervention 2: Group B: In the control group, patients will receive placebo capsules 7 days before surgery and as soon as they start oral administration after surgery until their discharge or for a maximum of one week. The drug will be prescribed twice a day after meals and oral or intravenous antibiotics should not be taken for at least 2 hours. 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 I have not decided yet.
public Ahmadreza Karimi
Golshan
Bandar Abbas Iran (Islamic Republic of) 7915363931 0763372145 karimi.ahmadreza@hums.ac.ir Bandare-abbas University of Medical Sciences scientific Mehrdad Sayadinia
Shahid Mohammadi Hospital
Bandarabbas Iran (Islamic Republic of) 7919915519 +98 76 3334 7008 drsaiiadinia@yahoo.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Patient satisfaction for inclusion in the study need for elective gastrointestinal surgery having a proper nutritional status for surgery no limit no limit Both Patient dissatisfaction to enter the study patient with underlying diseases such as diabetes, coagulation disorders, congenital or acquired immunodeficiency, liver cirrhosis, renal failure, acute pancreatitis D12 D13 C45.1 D01 D00 D12 D37 C22 C23 C24 Benign neoplasm of colon, rectum, anus and anal canal Benign neoplasm of other and ill-defined parts of digestive system Mesothelioma of peritoneum Carcinoma in situ of other and unspecified digestive organs Carcinoma in situ of oral cavity, esophagus and stomach Benign neoplasm of colon, rectum, anus and anal canal Neoplasm of uncertain behavior of oral cavity and digestive organs Malignant neoplasm of liver and intrahepatic bile ducts Malignant neoplasm of gallbladder Malignant neoplasm of other and unspecified parts of biliary tract Treatment - Drugs Placebo Group A: In the intervention group, patients will receive lactocare capsules 500mg (zist takhmir pharmaceutical company) 7 days before surgery and as soon as they start oral administration after surgery until their discharge or for a maximum of one week. The drug will be prescribed twice a day after meals and oral or intravenous antibiotics should not be taken for at least 2 hours. Group B: In the control group, patients will receive placebo capsules 7 days before surgery and as soon as they start oral administration after surgery until their discharge or for a maximum of one week. The drug will be prescribed twice a day after meals and oral or intravenous antibiotics should not be taken for at least 2 hours. Postoperative ileus. Timepoint: From the day of operation to the day of discharge. Method of measurement: The first gas passing after surgery by day. Number of days of hospitalization after surgery. Timepoint: From the day of operation to the day of discharge. Method of measurement: By day. Time to start oral feeding. Timepoint: From the day of operation to the day of discharge. Method of measurement: The patient's first day of oral feeding after surgery. Postoperative infection / Abdominal abscess / Wound infection. Timepoint: From the day of operation to the day of discharge. Method of measurement: Physical examination. Postoperative pneumonia. Timepoint: From the day of operation to the day of discharge. Method of measurement: Clinical examination and chest radiography at the discretion of the physician. Anastomosis leak. Timepoint: From the day of operation to the day of discharge. Method of measurement: Physical examination. Heart failure / Kidney failure / Liver disfunction. Timepoint: From the day of operation to the day of discharge. Method of measurement: Request laboratory tests if there are clinical signs. Nausea and vomiting. Timepoint: From the day of operation to the day of discharge. Method of measurement: Clinical examination and patient complaints. Pain and dyspepsia. Timepoint: From the day of operation to the day of discharge. Method of measurement: Clinical examination and patient complaints. Fever. Timepoint: From the day of operation to the day of discharge. Method of measurement: Physical examination. Mortality in 30 days after surgery. Timepoint: From the day of surgery to 30 days after surgery. Method of measurement: Death report by physician. SIRS. Timepoint: From the day of operation to the day of discharge. Method of measurement: Request tests if there are clinical signs. Researcher Approved 2021-06-21 Ethics committee of Hormozgan University of Medical Sciences Jomhory Boulevard - Shahid Mohammadi Hospital Bandar Abbas Hormozgan Iran (Islamic Republic of)