The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients
- Conditions
- Rectal Neoplasms
- Interventions
- Procedure: Stent-based Diverting Technique
- Registration Number
- NCT06204497
- Lead Sponsor
- Sir Run Run Shaw Hospital
- Brief Summary
The goal of this clinical trial is to evaluate the safety and efficiency of stent-based tiverting technique (SDT) versus ileostomy in rectal cancer patients. After the removal of the rectal tumor, participants who are at high risk for anastomotic leakage will either undergo SDT or ileostomies. Researchers will compare SDT to see if SDT could help patients save hospital stays, lower medical costs, and enhance their quality of life, and not alternatively avoid defunction stoma.
- Detailed Description
In patients with rectal cancer who have a high risk of anastomotic leakage, we aim to compare the safety and effectiveness of SDT versus ileostomy in this study. The primary endpoint of the study was severe complications that occurred within 90 days of the surgery. The secondary endpoints included total complications, the incidence of coloanal anastomotic leakage (Grade B/C), postoperative hospital stay and cost, and postoperative quality of life evaluation.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 570
- 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 after supportive treatment; or Preoperative renal replacement therapy (blood purification/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 of anastomosis is observed; or Intraoperative leak test was positive.
- History of previous rectectomy, except endoscopic mucosal resection or endoscopic submucosal 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 the past six months.
- Groups who are particularly vulnerable include those who suffer from mental disease, cognitive impairment, severe illness, adolescents, illiterates, women during pregnancy or breast-feeding, etc.
- Patients with severe complications who do not tolerate surgery or need emergency surgery due to complication (bleeding, obstruction or perforation)
- Unable ot radical resection, or underwent Miles or Hartmann or TaTME procedure, or requirement of simultaneous surgery for other disease (except the gallblader or appendix due to benign lesion).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stent-based Diverting Technique Stent-based Diverting Technique For Stent-based Diverting Technique, the small intestine measuring 15 cm from the ileocecal junction was pulled out through the median incision in the lower abdomen. After a length-wise incision was established in the mesenteric margin of the small intestine, the degradable stent was implanted, and the intestine was sutured. Then, the stent was held in place using an external tie around the bowel. Next, a mushroom-like tube (28 Fr) was placed into the intestine proximal (5-10 cm) to the aforementioned stent. The other side of the mushroom-like tube was inserted through the right lower abdominal wall and connected with a drainage bag. An abdominal drainage tube, or an anal tube, if necessary, was inserted in the proper location prior to the closure of the incision and the abdominal cavity. Abdominal X-ray was routinely performed every week to detect stent degradation, and the mushroom-like tube (28 Fr) was removed two days after stent degradation. Ileostomy Stent-based Diverting Technique There will be an ileostomy for the control group. An incision with a diameter of 2 cm will be performed in the lower abdomen, and layers will be separated into the abdominal cavity. The intestine, 20cm to the ileocecal juction under laparoscopic vision, will be pulled out. The anterior sheath of the rectus abdominis and the serous layer of the intestine will be sutured with an absorbable line. Then, the middle point of the mesangial margin of the intestine will be transected, and the intestine will be fixed on the skin. No volvulus or angular formation of the intestine should be confirmed laparoscopically.
- Primary Outcome Measures
Name Time Method Incidence of severe complications within 90-day Study group, from SDT to postoperative 90 days, Control group, from ileostomy to postoperative 90 days of reversal of stoma. Clavein-Dindo≥III
- Secondary Outcome Measures
Name Time Method Total complications Study group, from SDT to postoperative 90 days; Control group, from ileostomy, plus interval time before stoma reversal, to postoperative 90 days of reversal of stoma Clavein-Dindo I to V
Clinical anastomotic leakage Study group, from SDT to postoperative 90 days; Control group, from ileostomy, plus interval time before stoma reversal, to postoperative 90 days of reversal of stoma Grade B or Grade C
Postoperative hospital stay Study group, from SDT to discharge, and adding second postoperative hospital stay if the patient received the ileostomy. Control group, from ileostomy to discharge and from stoma reversal to discharge，up to six months for both group Postoperative hospital stay after SDT or ileostomy or reversal of stoma
Total medical Costs From first admission to end of follow-up or date of death from any cause, whichever came first, assessed up to six months for both group Including medical costs, surgery costs and other costs
Quality of life evaluation Study group, 90 days after SDT; Control group, 90 days after ileostomy SF-8 scale
Trial Locations
- Locations (20)
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Shengjing Hospital, China Medical University
🇨🇳Shenyang, Liaoning, China
Cancer Hospital, Peking University
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospita
🇨🇳Beijing, Beijing, China
The Affiliated Hospital, Qingdao University
🇨🇳Qingdao, Shandong, China
The Second Affiliated Hospital, Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Xiangya Hospital, Central South Universit
🇨🇳Changsha, Hunan, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China
Peking Union Hospital
🇨🇳Beijing, Beijing, China
Union Hospital, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Fujian Union Hospital, Fujian Medical University
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital, Jilin University
🇨🇳Jilin, Jilin, China
Sichuan Cancer Hospital, University of Electronic Science and Technology of China
🇨🇳Chengdu, Sichuan, China
ChangHai Hospital, The Second Military Medical University
🇨🇳Shanghai, Shanghai, China
Sir Run Run Shaw Hospital, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Cancer Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital, Ningbo University
🇨🇳Ningbo, Zhejiang, China