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临床试验/NCT07713472
NCT07713472尚未招募不适用

Benefits of Abdominal Massage After Colon Surgery for Cancer Following an ERAS Protocol (MATRAC_Ter): a Multicenter, Prospective, Randomized Clinical Trial

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
225
试验地点
1
主要终点
Evaluate the effectiveness of abdominal massage on the resumption of digestive transit after colonic resection surgery for cancer as part of ERAS protocol.

研究概览

简要总结

Postoperative ileus is a transient gastrointestinal dysmotility following abdominal surgery that leads to bloating, abdominal distention, visceral pain, nausea, vomiting, and delayed passage of flatus and stool. This paralytic state lasts longer when surgery involves the distal rather than the proximal digestive tract. Its incidence following colorectal surgery is between 10% and 30%. The main factors of postoperative ileus include age, predisposed constipation, method of anesthesia, type of surgical approach, perioperative analgesia, inflammatory reactions, and the psychopathology of the patient.

Enhanced recovery after surgery (ERAS) provides patients with optimal means to counteract or minimize the deleterious effects of surgery, in particular toward minimizing postoperative ileus. Expert consensus among surgeons, anesthesiologists, physiotherapists, dieticians, and other team members has been reached that stated 24 clinical statements concerning preoperative, peroperative and postoperative periods that should be included in current rehabilitation programs in colorectal surgery.

In China, massage, a 3000-year-old therapy guided by the theory of Yin and Yang, is widely used to treat various diseases. Chapelle and Bowe showed that abdominal massage reduced experimental postoperative ileus in a rat model and suggested that the effect was due to the attenuation of inflammation.

Abdominal massage has not widely been applied after colorectal surgery. Due to the scarcity of literature on abdominal massage, it has never been considered to be part of ERAS recommendations in colorectal surgery. Nevertheless, massage involving profound maneuvering of the viscera through abdominal palpation and breathing has been used as part of the local postoperative protocol in our department for many years with interesting results, and no complication has been reported. To our knowledge, only one study has explored the effect of mechanical abdominal massage on the duration of ileus after colectomy.

The aim of this prospective, multicenter randomized controlled trial (RCT) is to compare return of intestinal transit using the GI-2 criteria as defined by the time to first defecation and time to tolerance of solid food following the operation in two groups of patients following an ERAS protocol for colonic cancer surgery, one with and the other without early postoperative abdominal massage.

研究设计

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

入排标准

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

入选标准

  • Adults programmed to undergo surgery involving right, transverse or left colectomy due to cancer with anastomosis, regardless the approach (laparoscopy.
  • Laparotomy and Robot-assisted). Patients must be able to follow the colorectal surgery unit's ERAS protocol.
  • All included patients are required to have signed a study specific written informed consent form prior to inclusion in the trial.

排除标准

  • Patients required emergency surgery (obstruction or peritonitis),
  • A stoma for whatever reason,
  • Rectal cancer,
  • BMI > 40,
  • Psychiatric disorders,
  • An associated procedure, extensive resection,
  • Pregnancy, deprivation of liberty by judicial or administrative decision, or being under legal protection and patients with a hierarchical link to the principal investigator.

结局指标

主要结局

Evaluate the effectiveness of abdominal massage on the resumption of digestive transit after colonic resection surgery for cancer as part of ERAS protocol.

时间窗: Through study completion, 30 days

The primary outcomes is the return of intestinal transit, as defined by the time to first defaecation and time to tolerance of solid food following the operation, calculated in hours from skin closure.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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