Different anastomosis procedures in rectal cancer
Ontology highlight
ABSTRACT:
DISEASE(S): Malignant Neoplasm Of Rectum,Condition 1: Colon Cancer. Condition 2: Rectal Cancer,Malignant Neoplasm Of Colon
PROVIDER: 2485057 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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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: 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.
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Project description:Intervention 1: Intervention group: performing 6 week chemotherapy with mFOLFOX 6 or CapeOx and then carry out surgery and continue chemotherapy for 18 weeks. Intervention 2: Control group: Initial surgery followed by chemotherapy with mFOLFOX 6 or CapeOx for 24 weeks.
Primary outcome(s): Disease Free Survival. Timepoint: One year after intervention. Method of measurement: No relapse of cancer.;Histological response and down staging of tumor. Timepoint: After surgery. Method of measurement: Pathological and radiological examination.
Study Design: Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization on individuals was performed using a table of random numbers. Allocation concealment was carried out, Blinding description: The surgeon, pathologist and radiologist are unaware of allocated groups. Besides, the outcome assessor who evaluates the quality of life is unaware of the allocated groups. The data analyser will be blinded to the intervention groups.
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Project description:Intervention group: endoscopic washing with serum and brushing of fibrotic and granulation tissue.
Primary outcome(s): Repair of anastomosis leakage. Timepoint: Weekly until anastomosis leakage is repaired. Method of measurement: By colonoscopy.
Study Design: Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.
| 73636 | 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.
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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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Project description:Intervention 1: Intervention group 1: Treatment sessions based on Unified Transdiagnostic Treatment book of Barlow & et al will be performed according to the protocol (1 session per week, each session about 90 minutes – 8 sessions during 2 months). Measurements will be performed again in three times: the middle of treatment, the end of treatment and once in two months after the end of treatment. Intervention 2: Intervention group 2: Treatment sessions based on Acceptance and Commitment Therapy book of Hayes, Strosahl, & Wilson will be performed according to the protocol (1 session per week, each session about 90 minutes – 8 sessions during 2 months). Measurements will be performed again in three times: the middle of treatment, the end of treatment and once in two months after the end of treatment. Intervention 3: Control group: This group of 15 randomly selected individuals will receive no treatment for two months. However, the control group, which has been bothering to participate in the research, at the end of the study period is freely and intensively subject to one of the treatments of Acceptance and Commitment Therapy or Unified Transdiagnostic Treatment.
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Study Design: Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.
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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.
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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.
| 2484333 | ecrin-mdr-crc