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IRCT20091114002709N63 IRCT 2023-08-20 Iran University of Medical Sciences Initiation of oral feeding in upper gastrointestinal bleeding The effect of beginning time of oral feeding on the length of hospitalization, risk of rebleeding and nutritional status of patients with upper gastrointestinal bleeding caused by peptic ulcers and erosive diseases 2023-08-13 anticipated 166 Complete https://irct.ir/trial/71369 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The participants are individually assigned to two groups using R programming language statistical software by random permutations. The reason for using this method is that the distribution of both peptic ulcer disease and erosive disease is similar in two groups. N/A Condition 1: Peptic ulcer with bleeding. Condition 2: Acute gastritis with bleeding. Condition 3: Ulcer of esophagus with bleeding. Condition 4: Duodenitis with bleeding. Intervention 1: Intervention group: The intervention group, which includes 83 people, will be kept fasting for 24 hours after the endoscopy, if they meet the conditions to enter the study, and during this period the patient will receive injectable serums under the supervision of the attending physician. . After the fasting period, patients will be fed first with clear liquids for 6 hours, then with full liquids for 6 hours, and then with soft food for 12 hours. On the second day, the patients will be fed with light food that has little spices, fiber and fat and is non-flatulent, and on the third day, they will receive normal food, and after the patient tolerates the normal food, he can be discharged according to the nutritionist. Then, the patient will be followed up for a period of thirty days from entering the study. Intervention 2: Control group: The control group, which includes 83 people, will be kept fasting for 48 hours after the endoscopy, if they meet the conditions for entering the study, and during this period, the patient will receive injectable serums under the supervision of the attending physician. After the fasting period, patients will be fed first with clear liquids for 6 hours, then with solid liquids for 6 hours, and then with soft food for 12 hours. On the second day, the patients will be fed with light food that has little spices, fiber and fat and is non-flatulent, and on the third day, they will receive normal food, and after the patient tolerates the normal food, he/she can be discharged according to the nutritionist. Then, the patient will be followed up for a period of thirty days from entering the study. No - There is not a plan to make this available Justification or reason for not sharing IPD is According to the ethical protocol, personal information of volunteers is considered confidential.
public Farzad Shidfar
Department of Nutrition science, School of Health, Iran University of Medical Sciences, Next to the Milad Tower, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2755 shidfar.f@iums.ac.ir Iran University of Medical Sciences scientific Farzad Shidfar
Department of Nutrition science, School of Health, Iran University of Medical Sciences, next to the Milad Tower, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2755 shidfar.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age 18-65 years old Patients with bleeding due to peptic ulcer, both stomach and duodenum, and bleeding due to erosive esophagus, stomach and duodenum Patients with active bleeding, visible vessel without active bleeding and adherent clot based on Forrest's classification and endoscopic diagnosis Patients with a BMI between 18.5-35 18 years 65 years Both Patients admitted to the intensive care unit Patients with bleeding due to varicose veins, caustic substances Patients with gastrointestinal cancers Patients with clean base and flat pigmented spot ulcers Patients whose bleeding has not been treated Patients with gastrointestinal surgeries such as bariatric surgeries Patients who have been kept fasting for other reasons pregnant women Unwillingness to continue cooperation K27.4 K29.01 K22.11 K29.81 Chronic or unspecified peptic ulcer, site unspecified, with hemorrhage Acute gastritis with bleeding Ulcer of esophagus with bleeding Duodenitis with bleeding Rehabilitation Rehabilitation Intervention group: The intervention group, which includes 83 people, will be kept fasting for 24 hours after the endoscopy, if they meet the conditions to enter the study, and during this period the patient will receive injectable serums under the supervision of the attending physician. . After the fasting period, patients will be fed first with clear liquids for 6 hours, then with full liquids for 6 hours, and then with soft food for 12 hours. On the second day, the patients will be fed with light food that has little spices, fiber and fat and is non-flatulent, and on the third day, they will receive normal food, and after the patient tolerates the normal food, he can be discharged according to the nutritionist. Then, the patient will be followed up for a period of thirty days from entering the study. Control group: The control group, which includes 83 people, will be kept fasting for 48 hours after the endoscopy, if they meet the conditions for entering the study, and during this period, the patient will receive injectable serums under the supervision of the attending physician. After the fasting period, patients will be fed first with clear liquids for 6 hours, then with solid liquids for 6 hours, and then with soft food for 12 hours. On the second day, the patients will be fed with light food that has little spices, fiber and fat and is non-flatulent, and on the third day, they will receive normal food, and after the patient tolerates the normal food, he/she can be discharged according to the nutritionist. Then, the patient will be followed up for a period of thirty days from entering the study. Occurrence of rebleeding within 7 days after endoscopic therapy. Timepoint: Day 7 after receiving endoscopic therapy. Method of measurement: Questionnaire with confirmation of diagnosis by endoscopy. Occurrence of rebleeding within 14 days after treatment. Timepoint: Day 14. Method of measurement: Questionnaire with confirmation of endoscopic diagnosis. Occurrence of rebleeding within 30 days after treatment. Timepoint: Day 30. Method of measurement: Questionnaire with confirmation of endoscopic diagnosis. Body weight. Timepoint: The beginning of the study, the time of discharge from the hospital, the end of the study. Method of measurement: Digital scale with 100 gram accuracy. Duration of hospitalization after treatment. Timepoint: When discharged from the hospital. Method of measurement: Using the patient's medical record. Nutritional status of the patient. Timepoint: The beginning of the study, the time of discharge from the hospital, the end of the study. Method of measurement: "Nutritional risk screening-2002" questionnaire. Body mass index. Timepoint: The beginning of the study, the time of discharge from the hospital, at the end of the study. Method of measurement: Quetelet equation. Arm circumference. Timepoint: The beginning of the study, the time of discharge from the hospital, at the end of the study. Method of measurement: tape measure. Serum albumin. Timepoint: The beginning of the study, the time of discharge from the hospital, at the end of the study. Method of measurement: Blood sample. Serum total protein. Timepoint: The beginning of the study, the time of discharge from the hospital, at the end of the study. Method of measurement: Blood sample. Gastrointestinal clinical symptoms. Timepoint: During hospitalization, at the end of the study. Method of measurement: "Gastrointestinal Symptom Rating Scale (GSRS)" questionnaire. The level of patient satisfaction with the diet plan during hospitalization. Timepoint: During hospitalization. Method of measurement: questionnaire. Pain score. Timepoint: At the beginning of the study, during hospitalization, at the end of the study. Method of measurement: questionnaire. Iran University of Medical Sciences Approved 2023-08-08 Ethics committees of Iran university of medical sciences Iran University of Medical Sciences, Tehran, Iran. Shahid Hemmat Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)