The effects of perioperative probiotic treatment after colorectal surgery
Ontology highlight
ABSTRACT:
DISEASE(S): Benign Neoplasm Of Colon, Rectum, Anus And Anal Canal,Foreign Body In Colon, Initial Encounter,T18.4xxa,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,Malignant Neoplasm Of Colon,Other Specified Diseases Of Intestine
PROVIDER: 2482659 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description: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
| 2727544 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group A: 20 patients randomly selected and placed in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site were resected then anastomosed. Intervention 2: Intervention group B : 20 patients randomly selected and placed in the anterior repair group. Anterior intestinal defect within the ileostomy site was repaired.
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 two 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, collectors of results and analyzers, were blind to the study.
| 2492823 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: 1-Patients will take two capsules (daily) containing several probiotic strains from one week before the start of treatment until 10 days after the end of radiotherapy. Intervention 2: Intervention group: 2-Patients will take two capsules (daily) containing several probiotic strains from one week after the start of treatment to 10 days after the end of radiotherapy. Intervention 3: Control group: Two placebo capsules daily for ten days after the end of radiotherapy.
Primary outcome(s): Quality of life. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Questionnaire.;Gastrointestinal disorders. Timepoint: At the beginning of the study and 6 months after the intervention. Method of measurement: Clinical examination by an oncologist.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Participants will take probiotics for up to ten days after completing radiotherapy, Randomization description: Participants are randomly assigned to three groups to receive probiotics one week before the start of radiotherapy (n = 20), one week after the start of radiotherapy (n = 20) or placebo (n = 20), Blinding description: Randomization will be hidden from researchers and participants until the statistical analysis is completed.Another person who has no role in this clinical trial and is not aware of random allocation gives the capsules to participants.
| 2504274 | ecrin-mdr-crc
Project description:Intervention 1: intervention:
6 mg melatonin every night for 30 days. Intervention 2: control:
10 mg zolpidem at night for 30 days.;Treatment - Drugs;Treatment - Drugs;intervention:
6 mg melatonin every night for 30 days;control:
10 mg zolpidem at night for 30 days
Primary outcome(s): Sleep quality. Timepoint: At baseline, 1 month after the baseline and 2 months after baseline. Method of measurement: Pittsburgh Questionnaire.;Sleep quality. Timepoint: At baseline, 2 weeks and 1 month after the baseline and 2 months after baseline. Method of measurement: GSQS Questionnaire.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
| 2488847 | ecrin-mdr-crc
Project description:Intervention 1: The first intervention group: patients with a serum level of 25-hydroxyvitamin D3 less than 12 ng/ml receive 8 pearls of 50000 units of cholecalciferol from Zahravi Pharmaceutical Company one pearl weekly for 8 week and then 30 Tabs of 1000 units of cholecalciferol from Omid parsina damavand pharmaceuitical company, daily for 24 days. Intervention 2: The second intervention group: patients with a serum level of 25-hydroxyvitamin D3 of 12-20 ng/ml receive a total of 90 Tabs of 1000 units of cholecalciferol from Omid parsina damavand pharmaceuitical company, one pearl daily for 90 days. Intervention 3: The third intervention group: patients with a serum level of 25-hydroxyvitamin D3 of 20-30 ng/ml will receive a total of 60 pearls of 1000 units of cholecalciferol from Omid parsina damavand pharmaceuitical company accoriding to following command: Two days one pearl daily and then one day off for 3 months. Intervention 4: The fourth intervention group: patients with a serum level of 25-hydroxyvitamin D3 above 30 ng/ml will receive a total of 30 pearls of 1000 units of cholecalciferol from Omid parsina damavand pharmaceuitical company, one pearl every 3 days for 3 months.
Primary outcome(s): Depression score in Zung questionnaire. Timepoint: Before starting intervention, 90 days after starting to take cholecalciferol. Method of measurement: Zung Self-Rating Depression Scale questionnaire.;Anxiety score in Zung questionnaire. Timepoint: Before starting intervention, 90 days after starting to take cholecalciferol. Method of measurement: Zung Self-Rating Depression Scale qestionnaire.;Serum level of 25-hydroxy vitamin D3. Timepoint: Before starting the intervention and 90 days after starting cholecalciferol. Method of measurement: enzyme-linked immunosorbent assay.
Study Design: Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.
| 24659 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: Symptomatic treatment (Loperamide 4mg followed by 2 mg every 4 hours) with Probiotic yogurt (150 Grams) before breakfast and dinner twice a day for one week. Intervention 2: Control group: Symptomatic treatment Symptomatic treatment (Loperamide 4mg followed by 2 mg every 4 hours) with Regular yogurt (150 Grams) before breakfast and dinner twice a day for one week. Intervention 3: Control group: Symptomatic treatment Symptomatic treatment (Loperamide 4mg followed by 2 mg every 4 hours) with No intervention.
Primary outcome(s): Diarrhea frequency. Timepoint: Daily for one week after the start of the Intervention. Method of measurement: Patient’s report.;Diarrhea intensity. Timepoint: Daily for one week after the start of the Intervention. Method of measurement: Patient’s report.;Stool consistency. Timepoint: Daily for one week after the start of the Intervention. Method of measurement: Observation.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The study subjects were randomly allocated to yogurt + probiotic, yogurt, and control groups using Random Allocation Software (RAS) through random block sizes of 6 with an allocation ratio of 1:1. Random sequencing allocation was produced by the person who did not participate in the Sampling. The software produces sequences with 2 samples in each group. Containers were numbered from 1 to 90 according to the sequence generated.
| 2475794 | ecrin-mdr-crc
Project description:Intervention 1: Control group: Placebo was given every 12 hours/ orally from 4 days before through 10 days after operation. Intervention 2: Case group: Balance capsule made in England was given every 12 hours/ orally from 4 days before through 10 days after operation.;Treatment - Drugs;Treatment - Drugs;Control group: Placebo was given every 12 hours/ orally from 4 days before through 10 days after operation;Case group: Balance capsule made in England was given every 12 hours/ orally from 4 days before through 10 days after operation
Primary outcome(s): Surgical site infection. Timepoint: beginning of intervention and first, second, third, tenth and thirtieth days after operation. Method of measurement: fever, respiratory rate, pulse rate, pulse rate, cellulitis, dyscharge.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Giving the medicine to the patients was arranged in a double blind method so as to guarantee the minimum of the physician´s personal prejudgment when filling the patients’ form and the maximum of the patient´s cooperation. Neither the physician nor the patients had any knowledge about the type of medicine.
| 2480678 | ecrin-mdr-crc
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
| 23569 | ecrin-mdr-crc
Project description:Intervention 1: group two take a combination of probiotic and honey (two probiotic capsules and 30 grams honey per day, one capsule and 15 grams honey in the morning after breakfast and another one capsule in the evening, and 15 grams honey at night). Intervention 2: group three are the control group receive two placebo capsules (containing 500 mg of corn starch) per day, one capsule in the morning after breakfast and another one in the evening. Intervention 3: group one take probiotics )contained: Lactobacillus casei 1.5 × 109 CFU, Lactobacillus acidophilus 1.5 × 1010 CFU, Lactobacillus rhamnosus 3.5 × 109 CFU, Lactobacillus bulgaricus 2.5 × 108 CFU, Bifidobacterium breve 1 × 1010 CFU, Bifidobacterium longum 5 × 108 CFU and Streptococcus thermophilus 1.5 × 108 CFU per 500 mg(; two probiotic capsules per day, one capsule in the morning after breakfast and another one in the evening.;Treatment - Drugs;Treatment - Drugs;Treatment - Drugs;group two take a combination of probiotic and honey (two probiotic capsules and 30 grams honey per day, one capsule and 15 grams honey in the morning after breakfast and another one capsule in the evening, and 15 grams honey at night);group three are the control group receive two placebo capsules (containing 500 mg of corn starch) per day, one capsule in the morning after breakfast and another one in the evening;group one take probiotics )contained: Lactobacillus casei 1.5 × 109 CFU, Lactobacillus acidophilus 1.5 × 1010 CFU, Lactobacillus rhamnosus 3.5 × 109 CFU, Lactobacillus bulgaricus 2.5 × 108 CFU, Bifidobacterium breve 1 × 1010 CFU, Bifidobacterium longum 5 × 108 CFU and Streptococcus thermophilus 1.5 × 108 CFU per 500 mg(; two probiotic capsules per day, one capsule in the morning after breakfast and another one in the evening
Primary outcome(s): Diarrhea grade. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Common Toxicity Criteria system.;Stool consistency score. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Bristol scales.;Blood cell counts. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: cell counter machine.;Serum IgA level. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Autoanalyzer machine.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
| 2485704 | ecrin-mdr-crc
Project description:Intervention1: Onconeem: Onconeem 100 mg capsules will be taken twice daily along with SOC (palliative chemotherapy /radiotherapy of investigators choice) for a duration of 84 days
Control Intervention1: Onconeem matching placebo: The placebo will be taken twice daily along with SOC (e.g., palliative chemotherapy/radiotherapy of investigator choice) for a duration of 84 days
Primary outcome(s): Improvement in Quality of life (measured using FACT-G questionnaire) from baseline till End of treatment (EOT)Timepoint: Day 84
Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded
| 30959 | ecrin-mdr-crc