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临床试验/NCT02649153
NCT02649153已完成3 期

Effect of Smoked Plum and Chewing Gum on Postoperative Bowel Function Following Hepatic Resection

Guangxi Medical University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
240
试验地点
1
主要终点
Time to first peristalsis

研究概览

简要总结

Every patient undergoing surgery in the abdomen, such as hepatic resection, will experience temporary paralysis of bowel function. This study aims to evaluate whether smoked plum and chewing gum can reduce the bowel paralysis after hepatic resection in patients with hepatocellular carcinoma. One third of the study population will receive smoked plum, one third with chewing gum, and the last will act as empty control.

详细描述

Hepatectomy is widely used to treat patients with hepatocellular carcinoma (HCC), even those with intermediate and advanced disease. Despite its well-demonstrated clinical safety and efficacy in many patients, it is associated with postoperative morbidity and mortality. One complication after hepatectomy is delayed resumption of gastrointestinal function, known as postoperative ileus. This can decrease patient comfort and increase morbidity and mortality, prolonging hospital stay and raising healthcare costs. While postoperative ileus usually resolves within approximately 3 days, it can last longer in some cases as a condition termed postoperative paralytic ileus. Postoperative use of opioid-based analgesics can increase incidence of postoperative ileus.

No drugs or interventions to prevent or treat postoperative ileus have been approved by the China Drug Administration or the US Food and Drug Administration. Several studies show that chewing gum, a new and simple modality, can accelerate complication-free recovery of gastrointestinal function following gastrointestinal surgery and obstetrical-gynecological surgery. This raises the question whether postoperative smoked plum, or chewing gum can reduce risk of postoperative ileus following hepatectomy. To examine this question, we conducted a randomized controlled trial to compare incidence of postoperative ileus and length of hospital stay in HCC patients who received smoked plum, chewing gum or no intervention following hepatectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Underwent open hepatic resection
  • Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients

排除标准

  • Previously underwent exploratory laparotomy
  • Laparoscopic surgery
  • Known Central Nervous System tumors including metastatic brain disease
  • History of organ allograft
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
  • Pregnant or breast-feeding patients

研究组 & 干预措施

smoked plum

Experimental

Patients will receive smoked plum (3 piece each time, three times per day) starting in the first day after resection until flatus.

干预措施: smoked plum (Drug)

gum chewing

Active Comparator

Patients will receive gum chewing (three times per day) in the first day after resection until flatus.

干预措施: gum chewing (Drug)

结局指标

主要结局

Time to first peristalsis

时间窗: 3 days

次要结局

未报告次要终点

研究者

发起方
Guangxi Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jian-Hong Zhong

Director

Guangxi Medical University

研究点 (1)

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