The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients

Launched by SIR RUN RUN SHAW HOSPITAL · Jan 10, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach for treating rectal cancer patients who may face complications after surgery, specifically looking at a technique called the stent-based diverting technique (SDT) compared to the traditional method known as ileostomy. After removing a rectal tumor, patients at high risk of a problem called anastomotic leakage (which is when the connection between two parts of the intestine leaks) will be assigned to either the SDT or ileostomy group. Researchers want to see if using the SDT can lead to shorter hospital stays, lower healthcare costs, and a better overall quality of life for patients.

To be eligible for this trial, participants should be adults aged 18 to 80 who have been diagnosed with rectal adenocarcinoma and are at high risk for anastomotic leakage. Some factors that might qualify someone as high risk include being overweight, having certain health issues like diabetes or kidney problems, or having undergone radiation therapy before surgery. Participants will need to provide informed consent and will be monitored closely throughout the trial to ensure their safety and wellbeing. This study is currently recruiting patients, and it aims to provide valuable insights into improving care for those facing rectal cancer surgery.

Gender

ALL

Eligibility criteria

• 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).