Clinical Trial: A single-center prospective interventional study evaluating the safety, tolerability, and perioperative impact of early postoperative high-fiber diet after pulmonary resection (Japan)

Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061653) titled 'Prospective interventional study of postoperative high-fiber diet and perioperative outcomes after pulmonary resection' on July 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Yamagata University

Condition: Condition - Primary lung cancer, metastatic lung tumors, and other pulmonary diseases for which pulmonary resection is indicated. Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study aims to explore whether early postoperative oral intake with a defined amount of dietary fiber is associated with reduced perioperative complications and improved short- to mid-term recovery after pulmonary resection, including preservation of body weight and physical function. The study also focuses on the potential biological effects of early dietary fiber intake on efferocytosis, gut microbiota modulation, and perioperative immune responses. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - An in-hospital dietary intervention using an early postoperative high-fiber diet and dietary guidance after discharge will be provided. Specifically, a high-fiber diet will be initiated from the evening of the day of surgery, and dietary fiber intake will be promoted during hospitalization using fiber-enriched meals and/or fiber supplements. From postoperative day 1 to postoperative day 4, dietary intake, abdominal symptoms, bowel habits, and adverse events will be assessed. After discharge, patients will receive dietary guidance focused on a high-fiber diet for approximately two weeks, and dietary intake and tolerability will be evaluated.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients scheduled to undergo elective pulmonary resection for primary lung cancer, metastatic lung tumors, or other pulmonary diseases for which pulmonary resection is indicated. Patients scheduled to undergo pulmonary resection, including lobectomy, segmentectomy, or wedge resection. Any surgical approach, including video-assisted thoracoscopic surgery, robot-assisted thoracic surgery, or open thoracotomy, is permitted. Patients who can be managed according to a perioperative care protocol, including an ERAS protocol, in which oral intake is initiated on the day of surgery. Patients who have received a sufficient explanation of the study and provided written informed consent. Patients aged 18 years or older. Patients with an ECOG Performance Status of 0, 1. Key exclusion criteria - Patients scheduled to undergo pneumonectomy. Patients scheduled to undergo highly invasive concomitant procedures that are expected to substantially affect the timing, safety, or evaluation of postoperative oral intake, such as extensive bronchoplasty or combined resection of adjacent organs. Patients in whom the safety of study diet intake cannot be ensured because of dysphagia, a history of recurrent aspiration pneumonia, or other relevant conditions. Patients who are expected preoperatively to require enteral tube feeding or total parenteral nutrition as the main route of nutritional management. Patients with known allergy to the study diet or any of its components. Patients with a history of colitis or inflammatory bowel disease. Patients who underwent gastrointestinal surgery within 3 months before enrollment. Patients with a history of total colectomy. Patients with poorly controlled diabetes mellitus. Patients who received systemic antibiotics within 21 days before surgery. Patients receiving continuous systemic corticosteroid therapy. Patients who used probiotics, prebiotics, or supplements that may affect the gut microbiota within 14 days before surgery and are unable to discontinue them. Patients with dietary habits, such as a strict vegan diet, that are judged to substantially interfere with the standardized dietary intervention or dietary intake assessment. Patients judged by the principal investigator or sub-investigators to be unsuitable for participation in the study because of cognitive impairment, social circumstances, difficulty with adherence, safety concerns, or other reasons. Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 21 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070541

Disclaimer: Curated by HT Syndication.