Clinical study on prophylactic ileostomy in high-risk anastomotic fistula patients after TATME surgery using a degradable intestinal stent with a sheath

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400081382

Enrollment

Unknown

Registered

2024-02-29

Start date

2024-03-01

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

rectal cancer

Interventions

experimental group 1:Placement of degradable intestinal stent with straps

control group:Perform preventive ileostomy

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Primary rectal cancer (pathology). 2. Ta tme operation is required with high risk of anastomotic leakage (male, diabetes, preoperative radiotherapy and chemotherapy, and the tumor is less than or equal to 5cm from the anus). 3. = 18 years old, = 85 years old, regardless of gender. 4. ECOG (Eastern Cooperative Oncology Group) = 1 point 5. ASA (American Society of Anesthesiology) classification = Level 3 6. Participants voluntarily participate in this clinical study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Previously underwent rectal surgery. 2. Familial colorectal polyposis, hereditary non polypic colorectal cancer, active Crohn's disease or active ulcerative colitis. 3. Within June, there were cardiovascular and cerebrovascular diseases, unstable angina, and acute myocardial infarction. 4. Continuously use glucocorticoids within one month. 5. Pregnant or planned pregnant women and lactating women. 6. Severe mental disorders. 7. Severe complications that cannot tolerate surgery or require emergency surgery. During surgery, multiple rectal tumors were found, or distant metastases were found, or R0 resection was not possible, or TATME was not performed. 9. Patients who refuse to undergo this surgical procedure. 10. Patients whose family members refuse to accept this surgical method.

Design outcomes

Primary

Measure	Time frame
Surgical safety and feasibility indicators;Evaluation of surgical efficacy;Evaluation of minimally invasive effect;Evaluation of surgical complications;	—

Secondary

Measure	Time frame
Evaluation of operation time;Surgical cost evaluation;Length of stay and hospitalization costs of subjects;	—

Countries

China

Contacts

Public ContactMa Dan

Second Affiliated Hospital of Army Military Medical University (Xinqiao Hospital)

1054727918@qq.com+86 158 2355 5665

Outcome results

None listed

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