]>
IRCT20191027045254N1 IRCT 2021-11-27 Mashhad University of Medical Sciences Effectiveness of Enhanced Recovery After Surgery (ERAS) Effects of Enhanced Recovery After Surgery (ERAS) Program Implementation on Hospital Stay Duration and Costs in Children underwent Colostomy Closure Surgery 2022-01-10 anticipated 160 Complete https://irct.ir/trial/51658 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using a table of random numbers, the researcher determines the direction to read the numbers and touches one of the numbers with his eyes closed. When each item enters the study, the researcher moves in a predetermined direction. Even numbers will be assigned to the intervention group and odd numbers to the control group, Blinding description: In this study, data analyst is blind. N/A Colostomy. Intervention 1: Intervention group: ERAS protocol is performed in the patients of the intervention group. Implementation of the ERAS protocol includes the following: A. Preoperative: Intestinal prep only by oral Metronidazole, administration of clear liquids up to 2 hours before surgery, carbohydrate load as a serving of apple juice at two hours before surgery, Gabapentin loading dose of 15 mg/kg body weight three hours before surgery. B. Intraoperative: prophylactic antibiotic before surgical incision, prefer minimally invasive methods, not using unnecessary drains and tubes such as nasogastric tubes, maintaining normal temperature during surgery and preventing hypothermia, local anesthesia and regional blocks if effective, reduction and elimination of opioids, restriction of crystalloid intravenous fluids to 3-4 ml/kg/h. C. Postoperative: immediate limited mobility after surgery, limited clear fluid intake immediately after surgery as tolerated followed by normal diet, minimizing intravenous fluids and no bolus serum administration, avoiding opioids to relieve pain and administration of Acetaminophen 10 mg/ kg every 6 hours (maximum 650 mg every 6 hours), Ketorolac 0.5 mg/kg every 6 hours (maximum 30 mg every 6 hours), and Gabapentin 10 mg/kg every 8 hours (maximum 600 mg each 6 hours), control of nausea and vomiting by intravenous Ondansetron 0.1 mg/kg every 8 hours, aggressive and serious respiratory physiotherapy, and administration of intestinal motility drugs. Intervention 2: Control group: According to the routine of the surgical ward, patients will be NPO (nothing by mouth) 12 hours before surgery, receive intravenous antibiotics before surgery, and in some cases, mechanical preparation of the intestine with serial enema is applied. After surgery, patients will receive opioids in case of pain. Also, they would be NPO for up to 72 hours after surgery, followed by the normal diet, if the fluid diet is tolerated. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Reza ُShojaeian
3rd unit, No. 109, Farhad 15 St., Malekabad Blvd.
Mashhad Iran (Islamic Republic of) ٩١٧٧٨٩٧١۵٧ +98 51 3766 5574 shojaeianr@mums.ac.ir Mashhad University of Medical Sciences scientific Reza ُShojaeian
3rd unit, No. 109, Farhad 15 St., Malekabad Blvd.
Mashhad Iran (Islamic Republic of) ٩١٧٧٨٩٧١۵٧ +98 51 3766 5574 shojaeianr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age between 28 days to 14 years History of a prior surgery resulted in a colostomy Being a candidate of colostomy closure surgery 28 days 14 years Both Underlying disease that leads to tissue repair impairments (such as sever malnutrition or connective tissue disease K94.00 Colostomy complication, unspecified Treatment - Other Treatment - Other Intervention group: ERAS protocol is performed in the patients of the intervention group. Implementation of the ERAS protocol includes the following: A. Preoperative: Intestinal prep only by oral Metronidazole, administration of clear liquids up to 2 hours before surgery, carbohydrate load as a serving of apple juice at two hours before surgery, Gabapentin loading dose of 15 mg/kg body weight three hours before surgery. B. Intraoperative: prophylactic antibiotic before surgical incision, prefer minimally invasive methods, not using unnecessary drains and tubes such as nasogastric tubes, maintaining normal temperature during surgery and preventing hypothermia, local anesthesia and regional blocks if effective, reduction and elimination of opioids, restriction of crystalloid intravenous fluids to 3-4 ml/kg/h. C. Postoperative: immediate limited mobility after surgery, limited clear fluid intake immediately after surgery as tolerated followed by normal diet, minimizing intravenous fluids and no bolus serum administration, avoiding opioids to relieve pain and administration of Acetaminophen 10 mg/ kg every 6 hours (maximum 650 mg every 6 hours), Ketorolac 0.5 mg/kg every 6 hours (maximum 30 mg every 6 hours), and Gabapentin 10 mg/kg every 8 hours (maximum 600 mg each 6 hours), control of nausea and vomiting by intravenous Ondansetron 0.1 mg/kg every 8 hours, aggressive and serious respiratory physiotherapy, and administration of intestinal motility drugs. Control group: According to the routine of the surgical ward, patients will be NPO (nothing by mouth) 12 hours before surgery, receive intravenous antibiotics before surgery, and in some cases, mechanical preparation of the intestine with serial enema is applied. After surgery, patients will receive opioids in case of pain. Also, they would be NPO for up to 72 hours after surgery, followed by the normal diet, if the fluid diet is tolerated. Duration of hospitalization: The total number of hospitalization days as the days between the date of discharge and date of hospitalization. Timepoint: Once after patients discharge. Method of measurement: Based on the date of admission and date of discharge, recorded in the hospital information system. Time interval to tolerate oral intake: time interval between end of surgery and first oral feeding followed by no vomiting in hours. Timepoint: Once durnig hospital stay after oral intake tolerance. Method of measurement: Interval between the time of the first tolerated feeding recorded by the patient's nurse and the end time of the operation recorded in the operation report sheet in hours. Mashhad University of Medical Sciences Approved 2021-05-11 Ethics Committee of Medical Faculty, Mashhad University of Medical Sciences Faculty of Medicine, Mashhad University of Medical Sciences, Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)