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Comparison between anterior repair and resection-anastomosis of small intestine for closure of loop ileostomy

ABSTRACT: 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.

DISEASE(S): Function Of Bowel,Functional Intestinal Disorder, Unspecified

PROVIDER: 2492823 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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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 group1: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet, film and free access to fecal occult blood test. Intervention 2: Intervention group2: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet and film. Intervention 3: Intervention group3: free access to fecal occult blood test. Intervention 4: Control group: For the control group will not perform any of the action that will be taken for the intervention group.;Prevention;Prevention;Prevention;Prevention;Intervention group1: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet, film and free access to fecal occult blood test;Intervention group2: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet and film;Intervention group3: free access to fecal occult blood test;Control group: For the control group will not perform any of the action that will be taken for the intervention group. Primary outcome(s): Perceived severity. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Knowledge. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Perceived susceptibility. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Intention. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Perceived barriers. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Social support. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Self efficacy. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Perceived benefits. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire. Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Screening.

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.

Project description:Intervention 1: Intervention group: Participants in the intervention group will receive a Mediterranean diet menu. For this purpose, the energy required by the patients in the intervention group, according to the recommendations of the ASPEN guideline, is first considered 25 kcal per kg of body weight (current weight of patients), and then gradually over two weeks, this amount will be considered up to 35 kcal per kg of body weight. This calorie will be divided as follows: 35% of calories from fat, 45% of calories from carbohydrates, and 20% of calories from protein. Then, the sources of these macronutrients from different food groups will be considered based on the Mediterranean diet pyramid. Moreover, based on these food groups, a weekly menu will be set up for patients. To follow this diet, extra virgin olive oil will be given to patients. Intervention 2: Control group: Participants in the control group will receive nutritional advice for cancer patients and dietary recommendations for weight gain. Primary outcome(s): Nutritional status score. Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: PG-SGA (Patient Generated-Subjective Global Assessment) questionnaire.;Muscle strength. Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: Handgrip strength dynamometer.;Muscle mass. Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: Bio-Electrical Impedance Analysis (BIA).;Inflammatory markers (hs-CRP, IL-6, TNF-a). Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: enzyme-linked immunosorbent assay (ELISA). Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified block randomization will be performed based on the type of cancer (colon or rectum) using the site www.randomization.com. In this method, each group will be assigned one of the letters A and B, and randomization will be done in 4 blocks. This will be done for each type of cancer (colon or rectum) and two lists will be prepared for them. Within each class, patients will be randomly assigned to one of the two study groups in a 1: 1 ratio. The randomization process will be performed by someone outside the research team.

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Comparison between anterior repair and resection-anastomosis of small intestine for closure of loop ileostomy

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