Phase
Condition
Digestive System Neoplasms
Colorectal Cancer
Rectal Cancer
Treatment
Stent-based Diverting Technique
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Rectal adenocarcinoma confirmed pathologically.
- Rectal cancer patients with high-risk of anastomotic leakage(AL).
- Age from over 18 to under 80 years.
- Performance status of 0/1 on ECOG (Eastern Cooperative Oncology Group) scale.
- ASA (American Society of Anesthesiology) score class I, II, or III.
- Written informed consent. Definition of high-risk of AL (one of them):
- Preoperative body mass index (BMI) ≥30 kg/m2;
- Long-term use of glucocorticoids before surgery (≥2 weeks);
- Poor general condition: Preoperative serum albumin was less than 30.0g/L aftersupportive treatment; or Preoperative renal replacement therapy (bloodpurification/hemodialysis) is required; or diabetes;
- Preoperative neoadjuvant radiotherapy;
- Distance between tumor and anal anus (baseline MRI) ≤7cm
- The number of stapler used to cut the rectum during the operation ≥3; or the defect ofanastomosis is observed; or Intraoperative leak test was positive.
Exclusion
Exclusion Criteria:
- History of previous rectectomy, except endoscopic mucosal resection or endoscopicsubmucosal dissection.
- Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active colitis ulcerosa.
- History of unstable angina, myocardial infarction, cerebrovascular accident within thepast six months.
- Groups who are particularly vulnerable include those who suffer from mental disease,cognitive impairment, severe illness, adolescents, illiterates, women during pregnancyor breast-feeding, etc.
- Patients with severe complications who do not tolerate surgery or need emergencysurgery due to complication (bleeding, obstruction or perforation)
- Unable ot radical resection, or underwent Miles or Hartmann or TaTME procedure, orrequirement of simultaneous surgery for other disease (except the gallblader orappendix due to benign lesion).
Study Design
Study Description
Connect with a study center
Beijing Friendship Hospital
Beijing, Beijing 100000
ChinaSite Not Available
Cancer Hospital, Peking University
Beijing, Beijing 100000
ChinaSite Not Available
Chinese PLA General Hospita
Beijing, Beijing 310000
ChinaSite Not Available
Peking Union Hospital
Beijing, Beijing 100000
ChinaSite Not Available
Fujian Union Hospital, Fujian Medical University
Fuzhou, Fujian 350000
ChinaSite Not Available
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong 510000
ChinaSite Not Available
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei 430000
ChinaSite Not Available
Xiangya Hospital, Central South Universit
Changsha, Hunan 410000
ChinaSite Not Available
The First Affiliated Hospital, Jilin University
Jilin, Jilin 132000
ChinaSite Not Available
Shengjing Hospital, China Medical University
Shenyang, Liaoning 110000
ChinaSite Not Available
The Affiliated Hospital, Qingdao University
Qingdao, Shandong 266000
ChinaSite Not Available
Cancer Hospital, Fudan University
Shanghai, Shanghai 200000
ChinaSite Not Available
ChangHai Hospital, The Second Military Medical University
Shanghai, Shanghai 200000
ChinaSite Not Available
Sichuan Cancer Hospital, University of Electronic Science and Technology of China
Chengdu, Sichuan 610000
ChinaSite Not Available
Sichuan Provincial People's Hospital
Chengdu, Sichuan 610000
ChinaSite Not Available
Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, Zhejiang 310000
ChinaActive - Recruiting
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang 310000
ChinaSite Not Available
Zhejiang Cancer Hospital
Hangzhou, Zhejiang 310000
ChinaSite Not Available
The First Affiliated Hospital, Ningbo University
Ningbo, Zhejiang 315000
ChinaSite Not Available
The Second Affiliated Hospital, Wenzhou Medical University
Wenzhou, Zhejiang 325000
ChinaSite Not Available
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