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临床试验/NCT05485857
NCT05485857已完成不适用

Influence of Arrangement of Small Intestine Order on the Recovery of Bowel Function After Laparoscopic Colorectal Surgery.

Changhai Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年11月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
First flatus time after surgery

研究概览

简要总结

The method of arranging and restoring the position of the small intestine under laparoscopy is used to determine whether it can promote the recovery of intestinal function after colorectal surgery.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Pathologically confirmed colorectal cancer, patients undergoing colon cancer or radical resection of high rectal cancer;
  • •Tumor Stage (TNM): I-III;
  • •Age: >18 years old; <80 years old;
  • •ASA: I-III;
  • •Agree and sign the informed consent form.

排除标准

  • •Stoma patients;
  • •Patients with preoperative intestinal obstruction;
  • •Constipation patients (More than three days before the last bowel movement);
  • •Combined other organ resection patients;
  • •Stroke or spinal cord injury patients;
  • •Long-term opioid use patients;
  • •Patients with a history of previous abdominal surgery;
  • •Patients refused entry into the trial;

研究组 & 干预措施

Arrangement group

Experimental

Experimental group: After the completion of laparoscopic-assisted colorectal cancer surgery, the chief surgeon performed laparoscopic small bowel arrangement before closing the abdomen, straightening the small bowel from the colon-small bowel anastomosis or the ileocecal valve to the ligament of Trevor, and restoring the original position of the small bowel. Afterwards, close the abdomen.

干预措施: Arrangement of small intestine order before close the abdomen (Procedure)

No arrangement group

No Intervention

No arrangement group: After completing the routine operation of laparoscopic-assisted colorectal cancer surgery, the abdomen was closed directly.

结局指标

主要结局

First flatus time after surgery

时间窗: 50 hours

The investigators will record the time from the end of the surgery to the patient's first flatus time by hours.

次要结局

  • Time to liquid diet(70 hours)
  • Paralytic ileus time after surgery(30 days)
  • Postoperative hospital stay(30 days)
  • First defecate time after surgery(70 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wei Zhang

Head of colorectal surgery

Changhai Hospital

研究点 (1)

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