Rectal Neoplasms
Conditions
Keywords
Stent-based diverting technique, Ileostomy, Complication, Anastomotic leakage
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.
Interventions
PROCEDUREStent-based Diverting Technique
The stent-based diverting technique (SDT) contains two parts to achieve feces diversion One is a degradable solid intestinal stent to be implanted 20 cm from the terminal ileum and could be gradually degraded within 3-4 weeks. Another part is a drainage tube to be placed at the proximal 5-10 cm of the aforementioned stent. Given this SDT, intestinal contents could be diverted through the drainage tube, and the stent prevents the feces from entering the distal intestinal. After removing the drainage tube after 3-4 weeks, intestinal contents will freely access the distal intestinal space following the degradation of the stent. For patients, stoma reversal is avoided.
Sponsors
Sir Run Run Shaw Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The masking in this study is inappropriate because the patients in the SDT group do not have an abdominal stoma.
Intervention model description
The patients who were enrolled will either undergo ileostomy or SDT after the removal of the rectal tumor, which will be decided by chance.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Rectal adenocarcinoma confirmed pathologically. 2. Rectal cancer patients with high-risk of anastomotic leakage(AL). 3. Age from over 18 to under 80 years. 4. Performance status of 0/1 on ECOG (Eastern Cooperative Oncology Group) scale. 5. ASA (American Society of Anesthesiology) score class I, II, or III. 6. Written informed consent. Definition of high-risk of AL (one of them): 1. Preoperative body mass index (BMI) ≥30 kg/m2; 2. Long-term use of glucocorticoids before surgery (≥2 weeks); 3. 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; 4. Preoperative neoadjuvant radiotherapy; 5. Distance between tumor and anal anus (baseline MRI) ≤7cm 6. 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.
Exclusion criteria
1. History of previous rectectomy, except endoscopic mucosal resection or endoscopic submucosal dissection. 2. Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active colitis ulcerosa. 3. History of unstable angina, myocardial infarction, cerebrovascular accident within the past six months. 4. 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. 5. Patients with severe complications who do not tolerate surgery or need emergency surgery due to complication (bleeding, obstruction or perforation) 6. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXiuJun Cai, MD
Sir Run Run Shaw Hospital
Outcome results
None listed