Effectiveness of self-abdominal massage on gastrointestinal function in postoperative ileus: a randomised controlled trial protocol

自我腹部按摩对术后肠梗阻患者胃肠功能的影响:一项随机对照试验方案

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Abstract

INTRODUCTION: Postoperative ileus (POI) is a common complication after colorectal surgery, characterised by impaired gastrointestinal motility leading to abdominal distension, delayed flatus and defecation, nausea and vomiting. Self-abdominal massage (SM) can promote bowel peristalsis, but its clinical efficacy on improving colorectal cancer patients with POI treated with an intestinal decompression tube remains to be further verified. Therefore, this study aims to evaluate the efficacy and safety of SM in improving gastrointestinal function in colorectal cancer patients with POI treated with an intestinal decompression tube. METHODS AND ANALYSIS: This is a prospective, single-centre, randomised controlled, assessor-blinded and statistician-blinded trial. A total of 102 colorectal cancer patients with POI undergoing intestinal decompression tube placement will be recruited. Participants will be randomised in a 1:1:1 ratio to receive basic treatment (BT), BT plus SM (BT-SM) or BT plus simple physical stimulation (BT-SPS). The primary outcome is the time to first defecation after intestinal decompression tube placement. Secondary outcomes include time to first flatus, radiological evaluation, time to tolerability of semiliquid and solid foods, severity of nausea, vomiting, pain and abdominal distension, analgesic consumption, time to intestinal decompression tube removal, incidence of complications and adverse events after intestinal decompression tube placement. Outcome measures are collected at baseline, at 1, 2, 3 and 4 days after the end of the intervention. The primary time point will be 4 days postintervention. ETHICS AND DISSEMINATION: This study has been approved by the ethical application of the ‌Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine Ethics Committee (2025-K-49-01). All patients will be required to provide informed consent. Study results will be disseminated through publication in peer-reviewed journals and international conferences. TRIAL REGISTRATION NUMBER: ITMCTR2025001401.

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