The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients: A Prospective, Multicenter, Open-label, Non-inferiority, Randomized Controlled Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rectal Neoplasms
- Sponsor
- Sir Run Run Shaw Hospital
- Enrollment
- 570
- Locations
- 20
- Primary Endpoint
- Incidence of severe complications within 90-day
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Xiujun Cai
Director, Head of General Surgery, Principal Investigator, Clinical Professor
Sir Run Run Shaw Hospital
Eligibility Criteria
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 after supportive treatment; or Preoperative renal replacement therapy (blood purification/hemodialysis) is required; or diabetes;
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Incidence of severe complications within 90-day
Time Frame: Study group, from SDT to postoperative 90 days, Control group, from ileostomy to postoperative 90 days of reversal of stoma.
Clavein-Dindo≥III
Secondary Outcomes
- 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)
- 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)
- 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)
- 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)
- Quality of life evaluation(Study group, 90 days after SDT; Control group, 90 days after ileostomy)