Chemotherapy in locally advanced colon cancer
Ontology highlight
ABSTRACT:
DISEASE(S): Cancer Of The Large Intestine,Malignant Neoplasm Of Colon
PROVIDER: 2481605 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Intervention 1: Intervention group1: Coloanal End to End Anastomosis. Intervention 2: Intervention group 2: Side to End Anastomosis. Intervention 3: Intervention group 3: J poach coloanal anastomosis.
Primary outcome(s): Surgery period. Timepoint: onset to end of anesthesia. Method of measurement: Minute.;Hospital Stay. Timepoint: Discharge Time. Method of measurement: day.;Blood Loss. Timepoint: ?End of surgery. Method of measurement: CC.
Study Design: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization of individual by randomly drawing sealed envelopes, using a computer-based table of randomization by a surgical assistant, Blinding description: In this single-blind study, the participants were not familiar with three types of anastomosis surgery in this study. In addition, the observer, who completed the questionnaire, was not familiar with the groups. Similarly, the data analyzer did not know the study groups. However, the main researcher (surgeon) was informed about the groups, and all surgical procedures were performed by the same surgeon. The safety and data monitoring committee was also informed about the study groups.
| 2485057 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: The intervention group is subjected to peer support interventions for one month, at least twice a week by phone, and at least weekly by the Internet (virtual network) at least once a week. Intervention 2: The control group receives the same routine care and there is no intervention in it.
Primary outcome(s): Subjective well-being Score, in the Warwick Edinburgh Questionnaire. Timepoint: Before the intervention and one month after the end of the intervention. Method of measurement: Warwick Edinburgh subjective well-being Questionnaire.
Study Design: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are randomly assigned to two groups of intervention and control (using the random numbers table at www.randomization.com), Blinding description: The analyst will be unaware of the intervention and control groups and the data collected and which group it relates to.
| 2498403 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: Patients receiving 25 mg of captopril tablets daily for six weeks. Intervention 2: Control group: A placebo recipient who looks similar to Captopril and contains flour once a day for 6 weeks.
Primary outcome(s): Hand and foot syndrome. Timepoint: Every 3 weeks. Method of measurement: Physical examination.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization of patients between the intervention and control groups is done using random allocation software. In this software, the total sample size and number of nodes are entered into the software. The output of Shalam software is a list that randomly distributes patients in groups 1 and 2. Patients are divided into two groups according to the time of referral according to the list of the mentioned group until the end of sampling, Blinding description: This study is performed in double blinds and patients and researchers are unaware of the type of drug received. Drugs are prepared in coded form in similar packages and are provided to the executor for prescription to patients. Outcome assessment is also done by someone who is not in the study.
| 2480495 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group (family-centered empowerment model): The members will receive 3 to 5 sessions of education based on family-centered empowerment model, which covers four stages: awareness and cognition, self-efficacy, self-esteem, and evaluation. Education will be delivered in groups of 5 using group discussion. Intervention 2: Control group: The control group will not receive a specific educational intervention.
Primary outcome(s): Self-care ability. Timepoint: before the intervention, immediately after the intervention, and one month after the end of the intervention. Method of measurement: researcher-made self-care ability assessment questionnaire.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The participants will be allocated into experimental and control groups using the table of random numbers.
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Project description: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.
Primary outcome(s): 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.
Study Design: 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.
| 2482659 | 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: Control group: They will receives a placebo (oral pill) the night before the operation and a placebo (normal saline solution) after induction of anesthesia. Intervention 2: Intervention group 1: The night before the operation, 10 mg of melatonin and placebo during the operation. Intervention 3: Intervention group 2: The night before the operation, they receive a placebo (oral pill) and an intravenous bolus dose of 50 mg of ketamine after induction of anesthesia. Intervention 4: Intervention group 3: The night before the operation, they receive 10 mg of melatonin and an intravenous bolus dose of 50 mg of ketamine after induction of anesthesia.
Primary outcome(s): Postoperative delirium. Timepoint: 12 and 24 hours after surgery. Method of measurement: Confusion Assessment Method-Intensive Care Unit.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization lists are computer-based by a statistician and the participants and project managers will be completely unaware (blind) about the intervention and control groups. Placebo and melatonin pills are identical. Placebo pills are produced by Faculty of Pharmacy, Tehran University of medical science. The concealment of supplements will be done by a third person, and the participants and investigators are not aware of the groups’ assignments until the end of analysis, Blinding description: The pills are inside a sealed envelope with a specific code. Syringes containing ketamine or normal saline (as placebo) are stored in the operating room refrigerator and coded.Both the researcher and the nurse are unaware of the relationship between the code and the capsule type (melatonin or placebo/ketamine or placebo). Only the main researcher and
| 23604 | 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.
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Project description:Intervention 1: Intervention group: Roy follow-up care model. Intervention 2: Control group: Chemotherapy and routine nursing and medical care that are applied on a daily basis, and does not receive a training program based on the Roy adaptation pattern.
Primary outcome(s): The severity of depression, anxiety and stress. Timepoint: First and 2 months after the intervention. Method of measurement: Roy review And recognition form and anxiety scale, depression, stress DASS-21.
Study Design: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: Blocks randomization method was used to allocate individuals to groups, Blinding description: the allocation of patients to the groups was done by a nurse in the department that have no information about the treatment of A or B group. (Hiding random allocation and staying out of the intervention group).
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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
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