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

Not Applicable

Recruiting

• Conditions: Rectal Neoplasms

• 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.

Study Timeline

• Study First Submitted: 2023-12-12
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-12
• Last Update Posted: 2024-01-12
• Study Start: 2024-01-31
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 570

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Cancer Hospital, Peking University; 🇨🇳 Beijing, Beijing, China

Peking Union Hospital; 🇨🇳 Beijing, Beijing, China

Chinese PLA General Hospita; 🇨🇳 Beijing, Beijing, China

Fujian Union Hospital, Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

The First Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Union Hospital, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Xiangya Hospital, Central South Universit; 🇨🇳 Changsha, Hunan, China

The First Affiliated Hospital, Jilin University; 🇨🇳 Jilin, Jilin, China

Shengjing Hospital, China Medical University; 🇨🇳 Shenyang, Liaoning, China

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