A multicenter study of a biodegradable stent with an extension sleeve for one-stop anal preservation during Ta_tme surgery

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500107576

Enrollment

Unknown

Registered

2025-08-14

Start date

2025-03-04

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Rectal cancer

Interventions

Ta_tme+Degradable Intestinal Stent with Sleeve (Research Group):The research team performed Ta_tme surgery to remove the tumor while preserving the anus and placing a biodegradable intestinal stent w

Ta_tme+prophylactic ileostomy (control group):Perform Ta_tme surgery to remove the tumor while preserving the anus and performing prophylactic ileostomy

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

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

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. Cardiovascular and cerebrovascular diseases, unstable angina, acute myocardial infarction within 6 months. 4. Continuous use of glucocorticoids for one month. 5. Pregnant or planning pregnancy and lactating women. 6. Severe mental disorders. 7. Severe complications that cannot tolerate surgery or require emergency surgery. 8. Multiple tumors of the rectum are found during surgery, or distant metastases, or cannot be resected with R0, or TATME is not performed.

Design outcomes

Primary

Measure	Time frame
Incidence of anastomotic leakage within 90 days after surgery;	—

Secondary

Measure	Time frame
Overall complications within 90 days after surgery;Hospital stay and total cost within 90 days after surgery;Postoperative 90 day quality of life evaluation;	—

Countries

China

Contacts

Public ContactMa Dan

The Second Affiliated Hospital of Army Medical University

1054727918@qq.com+86 158 2355 5665

Outcome results

None listed

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