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IRCT20220530055031N8 IRCT 2025-10-22 Tehran University of Medical Sciences Assessing a novel oral feeding strategy to prevent postoperative ileus The impact of an innovative oral feeding approach on reducing ileus after elective open bowel surgeries: A comparison with traditional oral feeding 2025-11-22 anticipated 226 Recruiting https://irct.ir/trial/86849 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly assigned to either the control or intervention group using stratified randomization based on age, gender, BMI, and presence of major comorbidities to ensure balanced distribution of these key variables across groups. how is it possible, Blinding description: This was a single-blinded study. While both the participants and the nurse responsible for the data collection were aware of group assignments, the data analyst remained blinded to group allocation throughout the analysis process. N/A Postoperative ileus (POI) is a temporary impairment of bowel motility that commonly occurs after abdominal or colorectal surgery. It delays the return of normal gastrointestinal function, leading to abdominal distension, nausea, vomiting, intolerance to oral intake, and prolonged hospitalization. The study investigates strategies to reduce the duration and severity of postoperative ileus in patients undergoing elective open colorectal surgery.. Intervention 1: Intervention group: Patients in the intervention group received standard perioperative, intraoperative, and postoperative care according to the ERAS protocol. However, postoperative oral feeding followed a structured regimen designed to stimulate early gut motility. Upon full recovery from anesthesia and stabilization of vital signs, oral intake was initiated as follows: • First 12 hours: 15 mL of clear fluid every 15 minutes• Next 12 hours: 15 mL every 10 minutes • Following 24 hours: 15 mL every 5 minutes By 48 hours postoperatively, most patients were able to tolerate a full fluid diet. Solid food was introduced at 72 hours post-surgery. In cases where vomiting exceeded 100 mL within the first 24 hours, a nasogastric tube was reinserted, and oral feeding was temporarily paused. Intervention 2: Control group: Patients in the control group received the Standard ERAS protocol, including early initiation of oral feeding after anesthesia recovery. However, unlike the intervention group, there was no standardized feeding schedule. The volume and timing of oral intake were determined by clinical judgement, based on individual patient tolerance. Yes - There is a plan to make this available What will be shared: Deidentified demographic data, surgical details, and postoperative outcome variables (e.g., duration of ileus, length of hospital stay). When: Within 6 months after publication and for up to 3 years thereafter. To whom: Deidentified data and related documents will be available to qualified researchers affiliated with academic or research institutions, upon reasonable request, for purposes of independent verification, meta-analysis, or secondary scientific analyses, provided that data sharing complies with ethical and institutional regulations. Conditions: The shared data and documents may be used only for research purposes that are scientifically valid, ethically approved, and consistent with the objectives of the original study. Researchers must provide a formal data-sharing request, including a brief proposal outlining the intended analyses, and obtain approval from the Ethics Committee of Tehran University of Medical Sciences before data access is granted. Where to obtain: Researchers may request data by contacting the corresponding investigator via email at [amiratashi@sina.tums.ac.ir]. Requests will be reviewed for scientific validity and compliance with ethical guidelines. How to obtain: Researchers may request data by contacting the corresponding investigator via email at [insert your email]. Requests will be reviewed for scientific validity and compliance with ethical guidelines. Comments:
public Seyed Amir Miratashi Yazdi
Sina Hospital, Hasan Abad Square , Imam Khomeini avenue, Tehran, Iran
Tehran Iran (Islamic Republic of) 387611365 +98 21 6312 1267 amiratashi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Seyed Amir Miratashi Yazdi
Sina Hospital, Hasan Abad Square , Imam Khomeini Avenue, Tehran, Iran
Tehran Iran (Islamic Republic of) 387611365 +98 21 6312 1267 amiratashi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Adult patients aged 18 years or older., Patients scheduled for elective open colorectal surgery. Patients with no pre-existing gastrointestinal motility disorders. Patients with American Society of Anesthesiologists (ASA) physical status classification I–III. Patients able to provide written informed consent 18 years no limit Both Patients who underwent emergency colorectal surgery (e.g., for bowel obstruction, perforation, or peritonitis). Patients with a history of gastrointestinal motility disorders, such as gastroparesis, irritable bowel syndrome, or chronic constipation. Patients with chronic opioid use for more than two weeks prior to surgery. Patients who had major abdominal surgery within the previous six months. Patients who experienced intraoperative complications requiring deviation from the standard ERAS protocol. Patients requiring postoperative mechanical ventilation for more than 24 hours Patients who were unable to initiate oral feeding within 24 hours after surgery. Patients with cognitive impairments or language barriers that interfered with adherence to the feeding protocol. Treatment - Other Other Intervention group: Patients in the intervention group received standard perioperative, intraoperative, and postoperative care according to the ERAS protocol. However, postoperative oral feeding followed a structured regimen designed to stimulate early gut motility. Upon full recovery from anesthesia and stabilization of vital signs, oral intake was initiated as follows: • First 12 hours: 15 mL of clear fluid every 15 minutes• Next 12 hours: 15 mL every 10 minutes • Following 24 hours: 15 mL every 5 minutes By 48 hours postoperatively, most patients were able to tolerate a full fluid diet. Solid food was introduced at 72 hours post-surgery. In cases where vomiting exceeded 100 mL within the first 24 hours, a nasogastric tube was reinserted, and oral feeding was temporarily paused Control group: Patients in the control group received the Standard ERAS protocol, including early initiation of oral feeding after anesthesia recovery. However, unlike the intervention group, there was no standardized feeding schedule. The volume and timing of oral intake were determined by clinical judgement, based on individual patient tolerance. Resolution of postoperative ileus (POI) was defined as the return of bowel sounds and first passage of gas or stool in the absence of abdominal distension or vomiting. The need for nasogastric tube reinsertion (in cases of vomiting exceeding 100 mL within the first 24 hours) was recorded as an indicator of feeding intolerance and persistence of ileus. Timepoint: Monitoring was performed continuously from recovery until discharge, with key assessment intervals corresponding to the oral feeding protocol at 0–12 hours, 12–24 hours, 24–48 hours, and 48–72 hours postoperatively (reflecting the initiation and progression of oral feeding). The time of first passage of gas or stool, return of bowel sounds, and initiation of the first solid diet were recorded daily until discharge. Method of measurement: Bedside clinical examination: Assessment of bowel sounds and evaluation of abdominal distension.Recording of clinical events by the nurse or clinical team, including the time of first passage of gas or stool, tolerance of oral diet, and the volume of vomiting (for determining the need for nasogastric tube reinsertion).Data extraction from patient medical records and case report forms (CRFs), followed by statistical analysis using SPSS software. Tehran University of Medical Sciences Approved 2025-10-14 Ethic Committe of Tehran University of Medcial Science Tehran University of Medical Sciences, 16th Azar St., Enghelab Sq., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)