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临床试验/NCT02897531
NCT02897531已完成不适用

A Comparison of Surgical Outcomes Between End-to-side and Side-to-side Anastomosis After Laparoscopic Right Hemicolectomy: A Prospective Randomized Controlled Trial

Seoul National University Hospital4 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
4
主要终点
Cumulative Recovery Rate

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of end-to-side anastomosis after laparoscopic right hemicolectomy compared with that of side-to-side anastomosis. The investigators hypothesize that the end-to-side anastomosis may be associated with superior recovery compared with side-to-side anastomosis after laparoscopic right hemicolectomy under enhanced recovery program. The primary endpoint is the cumulative recovery rate, consisting of the recovery time of diet, pain, ambulation, and afebrile status.

详细描述

All patients will be received a laparoscopic right hemicolectomy by three experienced colorectal surgeons and randomly divided into two groups according to the method of anastomosis: - the end-to-side anastomosis group and the side-to-side anastomosis group. After the surgery, enhanced recovery program will be implemented. The primary endpoint is the cumulative recovery rate according to the method of anastomosis. The cumulative recovery rate is defined as the percentage of patients who are satisfied with all aspects of recovery time, including i) tolerance of diet for 24 hours, 2) analgesic-free (oral or intravenous (IV) analgesic drugs not necessary after cessation of patient-controlled analgesia (PCA)), 3) safe ambulation (ambulation of 600m without assistance), 4) afebrile status without major complications (fever was defined as body temperature greater than 37.2°C at axilla). Secondary endpoints are postoperative hospital stay, complications, the failure rate of the enhanced recovery program, and the readmission rate within 1 month after surgery. The expected cumulative recovery rate in postoperative day 7 is 90% in the end-to-side anastomosis group and 70% in the side-to-side anastomosis group. The sample size of 130 patients was calculated as follow: Based on the assumption that cumulative recovery rate will increase to 20% using the end-to-side anastomosis, it was calculated that 65 patients should be in each group. The sample size was calculated by the formula for a power 80%, alpha error of 0.05 and dropout rate of 10%.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have all of the following:
  • Age: 18 - 80
  • Right-sided colon cancer (adenocarcinoma, located in cecum to hepatic flexure)
  • Appropriate laboratory (Bone marrow) findings (Hemoglobin ≥ 10g/dl, White blood cell count ≥ 4,000/mm3, Platelet ≥ 100,000/mm3)
  • Appropriate renal function (Creatinine ≤ 1.5 mg/dl)
  • Appropriate cardio-pulmonary functions
  • Appropriate understanding of the study and provide the informed consent

排除标准

  • Patients who have 1 or more of the following:
  • Distant metastasis or locally advanced tumor which required combined resection of other organs, such as the ureter, duodenum, or small bowel.
  • Not suitable for laparoscopic surgery
  • Currently taking medication for dyschezia, such as constipation or diarrhea.
  • Not suitable for adapting enhanced recovery program due to underlying diseases, such as cardio-pulmonary disease, mental disorder, and etc.
  • Not suitable for participation in this clinical trial based on the judgment of the investigators

结局指标

主要结局

Cumulative Recovery Rate

时间窗: at 7 days after operation

The cumulative recovery rate is defined as the percentage of patients who are satisfied with all aspects of recovery time. Recovery time includes the following: 1. Tolerance of diet for 24hours 2. Analgesic-free status (oral or intravenous (IV) analgesic drugs not necessary after cessation of patient-controlled analgesia (PCA)), 3. Safe ambulation (ambulation of 600m without assistance), 4. Afebrile status without major complications (fever was defined as body temperature greater than 37.2°C at axilla).

次要结局

  • Postoperative Hospital Stay(at discharge from hospital, an average of 1 week)
  • Postoperative Complications(at 30 days)
  • Failure Rate of the Enhanced Recovery Program(at discharge from hospital, an average of 1 week)
  • Readmission Rate Within 1 Month After Surgery(at 30 days)

研究者

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

Sung-Bum Kang

Professor

Seoul National University Hospital

研究点 (4)

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