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The Safety of Stent-Based Diverting Technique after Low Anterior Resection in Rectal Cancer Patients: A Prospective, Multicenter, Open-label, Randomized Controlled Study (STAR study)

The Safety of Stent-Based Diverting Technique after Low Anterior Resection in Rectal Cancer Patients: A Prospective, Multicenter, Open-label, Randomized Controlled Study (STAR study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049953
Enrollment
Unknown
Registered
2021-08-15
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer

Interventions

Stent-based Diverting Technique Group:Stent-based Diverting Technique
Prophylactic ileostomy group:Prophylactic ileostomy

Sponsors

Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Primary solitary rectal cancer confirmed pathologically; 2.Patients receive low anterior resection; 3.Age from over 18 to under 80 years; 4.ECOG(Eastern Cooperative Oncology Group)<=1; 5.ASA(American Society of Anesthesiology) grade <=III; 6.Nutrition score (NRS)<=2; 7.Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous rectal surgery; 2. Familial colorectal polyposis, hereditary non-polyposis colorectal cancer, active Crohn's disease or active ulcerative colitis; 3. Cardio-cerebrovascular disease, unstable angina pectoris, acute myocardial infarction within six months; 4. Continue to use glucocorticoids within one month; 5. Pregnant or planning pregnancy and lactating women; 6. Severe mental disorder; 7. Other adjuvant therapy before surgery: targeted/immunotherapy; 8. Serious complications cannot tolerate surgery or require emergency surgery; 9. Intraoperative discovery of multiple rectal tumors or distant metastasis.

Design outcomes

Primary

MeasureTime frame
Severe complications within post-operative 90 days;

Secondary

MeasureTime frame
Total complications within post-operative 90 days;The incidence of coloanal or colorectal anastomosis within post-operative 90 days ;Post-operative hostipal stay and cost ;Quality of life assessment at post-operative 90-day ;Changes in intestinal flora before operation and at post-operative 90-day ;

Countries

China

Contacts

Public ContactCai Xiujun

Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

srrsh_cxj@zju.edu.cn+86 13805738266

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026