The Value of Bowel Sounds in Evaluating Postoperative Intestinal Function Recovery in Colorectal Cancer Patients: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Occurrence of postoperative ileus ( POI) after surgery.
研究概览
简要总结
This study enrolls patients scheduled to undergo curative surgery for colorectal cancer. Bowel sounds will be assessed preoperatively and postoperatively. By comparing intraoperative variables, the incidence of perioperative complications, reoperation rates, and postoperative outcomes-including time to first flatus, resumption of oral intake, and occurrence of intestinal obstruction-this study aims to investigate the association between perioperative bowel sounds and postoperative recovery, and provide evidence-based support for the clinical application of bowel sound monitoring.
Supplementary Definitions
详细描述
Colorectal cancer (CRC) is the third most common malignancy worldwide and the second leading cause of cancer-related mortality. In recent years, both the incidence and mortality of colorectal cancer in China have shown a significant upward trend. With population aging and lifestyle changes, the disease is increasingly affecting younger individuals, with the proportion of patients under 40 years of age steadily rising. Treatment strategies vary according to disease stage; however, for most cases amenable to primary resection, surgical intervention remains the cornerstone of therapy.
With the widespread implementation of Enhanced Recovery After Surgery (ERAS) protocols, postoperative rehabilitation has been substantially improved through optimization of preoperative, intraoperative, and postoperative management strategies, such as shortened preoperative fasting, the use of laparoscopic techniques, and early postoperative oral intake, thereby facilitating accelerated recovery and earlier discharge. Following curative surgery for colorectal cancer, patients commonly experience reduced or transiently absent intestinal motility due to surgical manipulation and the effects of anesthesia, with gradual return to normal function over several days. Early postoperative feeding has been shown to promote gastrointestinal functional recovery.
However, a subset of patients may exhibit delayed recovery of bowel function, characterized by diminished bowel sound activity, prolonged time to first flatus, and often accompanied by abdominal distension. Postoperative ileus (POI) is one of the most common causes of delayed postoperative gastrointestinal recovery and typically presents as transient suppression of gastrointestinal motility. When the duration exceeds the expected physiological range, potential pathological conditions, such as early postoperative small bowel obstruction (EPSBO), should be considered. In such circumstances, oral intake may exacerbate the ileus and even precipitate intestinal obstruction. Therefore, timely differentiation and accurate diagnosis of the patient's postoperative gastrointestinal status are of critical importance.
Abdominal auscultation, as a noninvasive diagnostic technique, has a history spanning several centuries. In 1905, Cannon was the first to report systematic investigations of abdominal auscultation, proposing that regular bowel sounds are generated by intestinal peristaltic activity. Subsequent studies have demonstrated that bowel sounds vary by anatomical location: sounds originating from the small intestine are typically high-pitched, high-amplitude, and frequent, whereas colonic sounds are lower in frequency, weaker in amplitude, and less frequent. Postoperatively, the recovery of gastrointestinal motility differs among intestinal segments, with the small intestine recovering first, followed by the stomach and the colon.
Abdominal auscultation has been widely used as an adjunctive tool in the evaluation of conditions such as intestinal obstruction and ileus owing to its immediacy and convenience and is commonly applied in patients with delayed postoperative gastrointestinal recovery. However, the reliability of auscultation-based assessment remains controversial because of the inherent subjectivity in clinicians' descriptions of bowel sounds. A prospective study by Felder et al. demonstrated a low sensitivity of 22%-32% for manual auscultation in distinguishing healthy from diseased individuals, along with low positive predictive values of 23%-44%. Similarly, Thomas et al. conducted a prospective study examining the relationship between auscultated bowel sounds and postoperative oral tolerance and flatus, finding no significant correlation between bowel sounds and postoperative abdominal distension, flatus, defecation, or tolerance of oral intake.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-80 years.
- •Histopathologically confirmed colorectal adenocarcinoma according to the WHO 2022 classification.
- •No restriction on prior neoadjuvant or other antitumor therapies, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
- •Able to understand the study requirements and voluntarily provide written informed consent (patient and/or legally authorized representative).
- •Able to communicate effectively with the investigators and willing to comply with all study procedures, including postoperative management and follow-up.
排除标准
- •Significant organ dysfunction indicating inability to tolerate surgery or an unacceptably high perioperative risk, including:
- •Severe cardiac dysfunction (NYHA Class III or IV).
- •Severe hepatic dysfunction (MELD score >12).
- •Severe renal dysfunction (eGFR <30 mL/min/1.73 m² [CKD stage 4-5] or end-stage renal disease requiring dialysis).
- •Severe pulmonary dysfunction (resting PaO₂ <60 mmHg on room air or respiratory failure requiring long-term oxygen therapy or mechanical ventilation).
- •Participation in another clinical study within 4 weeks before enrollment or concurrent participation in another interventional clinical study.
- •Emergency surgery required because of intestinal obstruction, perforation, or other acute abdominal conditions.
- •Severe psychiatric disorders that would interfere with compliance with perioperative management or follow-up.
- •Pregnant or breastfeeding women.
- •Any other clinical or laboratory abnormality that, in the opinion of the investigator, would make the participant unsuitable for the study.
结局指标
主要结局
Occurrence of postoperative ileus ( POI) after surgery.
时间窗: From surgery through postoperative day 30
次要结局
- Postoperative Complications within 30 Days(From surgery through postoperative day 30)
- Length of postoperative hospital stay(From surgery through postoperative day 30)
- Time to first flatus(From surgery through postoperative day 30)
- Time to first defecation(From surgery through postoperative day 30)
- Total hospitalization cost (before reimbursement)(From surgery through postoperative day 30)
- Bowel Sound Characteristics(From surgery through postoperative day 30)
