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A prospective, open-control clinical study of the safety and feasibility of single-incision preventive double-lumen ileum fistula in laparoscopic radical resection of low rectal cancer

A prospective, open-control clinical study of the safety and feasibility of single-incision preventive double-lumen ileum fistula in laparoscopic radical resection of low rectal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061100
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

Rectal cancer

Interventions

Treatment Group:A single incision was made in the right lower abdomen for tumor specimen removal and terminal ileum double lumen fistula
control group:The tumor specimen was taken out through the left lower abdominal incision, and the terminal ileum double-lumen fistula was performed through the right lower abdominal incision

Sponsors

The First Affiliated Hospital of Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. NRS2002 nutrition score < 3; 3. ECOG physical condition score 0-1; 4. Resectable rectal cancer without distant metastasis confirmed by histology or cytology (clinical staging according to AJCC TNM stage 8 consistent with T1-3NXM0); 5. Not receive any preoperative anti-tumor therapy for rectal cancer (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 6. Imaging examination indicated that the tumor was located in the lower segment of rectum, and anastomosis with tubular stapler was feasible after resection, and anastomosis was less than 5cm from the anal margin; 7. Patients who can tolerate laparoscopic surgery; 8. Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients who received neoadjuvant radiotherapy/chemotherapy before surgery; 2. Patients with intraoperative T4Nx or TxNxM1 rectal cancer; 3. Patients with a history of malignant tumor at the same time or at different times (within 5 years); 4. Patients with a history of abdominal and pelvic surgery; 5. Patients with tumors or metastases in perirectal organs or pelvic floor need to be excised with perirectal organs; 6. Severe intestinal edema at the proximal end of anastomosis caused by intestinal obstruction and other factors; 7. Patients with extensive abdominal inflammation, such as intestinal perforation or intestinal bleeding, need emergency surgery; 8. ASA grade IV-V; 9. Serious cardiovascular diseases, uncontrollable infections or uncontrollable co-morbidities; 10. Patients or family members who do not accept preventive fistula; 11. Unable to complete the test program or follow-up plan due to family, social or geographical conditions.

Design outcomes

Primary

MeasureTime frame
Incision healing grade;ostomy complications;unplanned secondary operation rate;Operation time;suture time of fistula;VAS score of postoperative pain;

Countries

China

Contacts

Public ContactLi Yunlong

The First Affiliated Hospital of Air Force Military Medical University

liyunlong1213@163.com+86 13022833973

Outcome results

None listed

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