The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Pa… (NCT06204497) | Clinical Trial Compass
CompletedNot Applicable
The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients
China570 participantsStarted 2024-01-31
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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.
✓. Preoperative body mass index (BMI) ≥30 kg/m2;
✓. Long-term use of glucocorticoids before surgery (≥2 weeks);
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.
✕
What they're measuring
1
Incidence of severe complications within 90-day
Timeframe: Study group, from SDT to postoperative 90 days, Control group, from ileostomy to postoperative 90 days of reversal of stoma.
. 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).