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A multicenter, open, parallel, randomized controlled, non inferiority clinical study protocol comparing transanal drainage tube placement and ileal prophylactic fistula for preventing anastomotic fistula in laparoscopic low rectal cancer

A multicenter, open, parallel, randomized controlled, non inferiority clinical study protocol comparing transanal drainage tube placement and ileal prophylactic fistula for preventing anastomotic fistula in laparoscopic low rectal cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089822
Enrollment
Unknown
Registered
2024-09-18
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-23

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

Conditions

low rectal cancer

Interventions

experimental group:After intra-abdominal anastomosis is completed, a drainage tube is placed through the anus
control group:After the completion of intra-abdominal anastomosis, perform prophylactic fistulization on the terminal ileum

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age range: 18-80 years old 2) Diagnosed with primary rectal cancer 3) The distance between the tumor and the anal margin is 7-3cm 4) Anesthesia ASA classification is I-III 5) Proposed laparoscopic low anterior resection for rectal cancer 6) Preoperative ECOG physical status score: 0 or 1 7) The main organ functions are normal and meet the following requirements: A. Blood routine examination (no blood transfusion in the past 14 days): HB = 90g/L; ANC =1.5×109/L; PLT =80×109/L B. Blood biochemistry test: BIL<1.5 times the upper limit of normal (ULN); ALT and AST<2.5 × ULN; Crea = 1 × ULN.

Exclusion criteria

Exclusion criteria: 1) Patients undergoing emergency surgery 2) Contraindications for laparoscopic surgery: Patients who are deemed unsuitable for laparoscopic surgery based on preoperative evaluation. 3) Received neoadjuvant radiotherapy before surgery 4) Patients with combined inflammatory bowel disease, FAP, recurrent rectal cancer or multiple primary cancers 5) The proposed surgical approach is non laparoscopic low anterior resection for rectal cancer, such as intersphincteric resection (ISR) for rectal cancer and abdominal perineal resection (APR) for rectal cancer. 6) History of unstable angina, myocardial infarction, cerebral infarction, or cerebral hemorrhage in the past 6 months. 7) History of continuous systemic corticosteroid treatment within the past month. 8) Pulmonary function test FEV1 is less than 50% of the expected value. 9) Pregnant or lactating women. 10 suffer from severe mental illness. 11) Refuse to sign the informed consent form for the study.

Design outcomes

Primary

MeasureTime frame
The incidence of anastomotic fistula within 30 days after surgery;

Secondary

MeasureTime frame
The incidence of severe surgical related complications within 30 days after surgery;

Countries

China

Contacts

Public ContactYang Lie

West China Hospital of Sichuan University

lie_222@163.com+86 189 8060 2267

Outcome results

None listed

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