Dataset Information

Evaluation of the effect of synbiotic on complications after gastrointestinal surgery

ABSTRACT: 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. Primary outcome(s): 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. Study Design: 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 resp

DISEASE(S): Malignant Neoplasm Of Other And Unspecified Parts Of Biliary Tract,Benign Neoplasm Of Other And Ill-defined Parts Of Digestive System,Neoplasm Of Uncertain Behavior Of Oral Cavity And Digestive Organs,Carcinoma In Situ Of Oral Cavity, Esophagus And Stomach,Benign Neoplasm Of Colon, Rectum, Anus And Anal Canal,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,Malignant Neoplasm Of Gallbladder,Malignant Neoplasm Of Liver And Intrahepatic Bile Ducts,Mesothelioma Of Peritoneum,Carcinoma In Situ Of Other And Unspecified Digestive Organs

PROVIDER: 2727544 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Similar Datasets

Project description:Intervention 1: Intervention group A: 32 patients randomly select and place in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site are resected then hand sewn anastomosis will be done. Intervention 2: Intervention group B : 32 patients randomly select and place in the anterior repair group. Anterior intestinal defect within the ileostomy site will be repaired. Intervention 3: Intervention group C: 32 patients randomly select and place in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site are resected then anastomosis will be done by the stapler. Primary outcome(s): The first day of defecation. Timepoint: daily up to one week. Method of measurement: question from the patient in daily ward visits.;The first day of flatus. Timepoint: daily up to one week. Method of measurement: question from the patient in daily ward visits.;The first day of oral feeding. Timepoint: daily up to one week. Method of measurement: stariting of oral diet based on surgeons decision.;Post operation early complications. Timepoint: daily up to one month. Method of measurement: question from the patient in daily ward visits.;Post operation late complications. Timepoint: monthly up to 6 months. Method of measurement: question from the patient in monthly clinic visits. Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients were randomly assigned into three groups using randomly permuted blocks method. random allocation sequence was generated by the online platform www.randomization.com, Blinding description: In this double-blind study, participants, Investigator and Outcome assessor , were blind to the study.Before the surgery, the patients are randomly divided into three groups, which the patients and investigators do not know about it, and then the surgeon in the operating room is informed about the type of surgery of each patient, and the surgery is performed, and then the patients are transferred to the surgery ward. The patients are visited by the another surgeon ( investigator and outcome assessor) who is blind with the type of surgery of each patient and the information and data of the patients are collected and then the information is se

Project description:Intervention 1: Intervention group: Nanocurcumin 40 mg capsule formulated by Exir Nanosina Inc. thrice a day (after breakfast, lunch and dinner) for 6 21-day courses of XELOX or FOLFOX regimen. Intervention 2: Control group: Placebo with the same appearance prepared by Exir nano Sina Inc. thrice a day (after breakfast, lunch and dinner) for 6 21-day courses of XELOX or FOLFOX regimen. Primary outcome(s): Metastatic extent. Timepoint: after three courses of chemotherapy and the end of six courses. Method of measurement: Periodic Radiography.;Assess CRP levels. Timepoint: At the beginning and after the end of three and six chemotherapy courses. Method of measurement: Blood test.;Assess CEA and CA19-9 levels. Timepoint: At the end of three courses and six courses of chemotherapy. Method of measurement: Blood test.;Radiographic response of the tumor. Timepoint: after three courses of chemotherapy and the end of six courses. Method of measurement: (RECIST1.1), based on the doctor’s clinical examination. Study Design: Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization using Randomization.com will implemented. This method uses simple randomization models such as head or tail, using a random number table or using computer randomization methods, and for example, each client by dropping coin will include in control or intervention group. This method is very simple to implement. Patients will receive enrollment number 1 or 2, respectively, and enter one of two groups of drugs or placebo, Blinding description: Nano-curcumin and placebo soft gels packages in identical bottle will be delivered to the clinician. Patients who meet the inclusion criteria will be selected by clinician to be included in the study, randomly assigned to a drug or placebo group and be given a bottle with A or B mark. The physician and the resident of clinical pharmacy will evaluate patients in the course of treatment. Dat

Project description:Intervention 1: Stinging nettle tablet, produced in the company of barijessence, 400 mg tablet, three times a day for 3 months in intervention group. Intervention 2: Placebo, tablets containing starch, produced in Tehran University of Medical Sciences, 400 mg tablet, three times a day for 3 months in control group.;Treatment - Drugs;Placebo;Stinging nettle tablet, produced in the company of barijessence, 400 mg tablet, three times a day for 3 months in intervention group;Placebo, tablets containing starch, produced in Tehran University of Medical Sciences, 400 mg tablet, three times a day for 3 months in control group. Primary outcome(s): Erythrocyte Sedimentation Rate. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Automation Method (mm/h).;High- sensitivity C- reactive protein. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is mg/dl.;Quality of life. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Inflammatory Bowel Disease Questionnaire-Short Form.;White blood cell. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Flow cytometry Method (cells/ml).;Superoxide dismutase. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is ng/ml.;Platelet. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Flow cytometry Method (cells/µl).;Fecal calprotectin. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is µg/g.;Tumor necrosis factor alpha. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is ng/ml. Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization is done by stratified blocked randomization. Placebo in the form of a double-blind to the participants in this study given. Researchers and patients are blinded to the treatment and placebo groups.

Dataset Information

Evaluation of the effect of synbiotic on complications after gastrointestinal surgery

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets