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Higher ligation versus lower ligation of vascular during TME surgery of rectal cancer: a randomized control study of multiple centers

Higher ligation versus lower ligation of vascular during TME surgery of rectal cancer: a randomized control study of multiple centers

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10001109
Enrollment
Unknown
Registered
2010-11-21
Start date
2010-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Rectal cancer

Interventions

Lower ligation group:TME surgery with lower vascular ligations (vascular ligation at root of superior rectal artery 0.5cm from bifurcation of inferior mesenteric artery)
Higher ligation group:TME surgery with higher vascular ligations (vascular ligation at root of inferior mesenteric artery 0.5cm from abdominal aorta)

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 70; 2. Colonscopy: tumor below 12cm from dentate line; 3. Pathological diagnosis of adenocarcinoma; 4. Resectable tumor; 5. CXR/CT, abdominal ultrasound/CT exclude metastasis; 6. No history of previous gastrointestinal surgery; 7. Without complete bowel obstruction; 8. Good cardiopulmnoary functions; 9. Expectation survival period more than 6 months; 10. Karnofsky score more than 70; 11. WBC > 3.5*10^9/ml, PLT> 10*10^9/ml, T-Bil 50ml/min.; 12. Female patients in trails must under contraception. And patients who is menopause should be assureed for 12 months and pregnancy should be ruled out; 13. No other relevant diseases (ex: tumors in other sites or serious disease heart or central nervous system, CNS).

Exclusion criteria

Exclusion criteria: 1. Pathological diagnosis other than adenocarcinoma and mucinous carcinoma; 2. Uncontroled underlying diseases (unstable angina etc); 3. Previous history of immunosuppresive therapy (including corticosteroids therapy); 4. Past history or excisting other malignancy; 5. Difficulty in endure anesthesia and surgery; 6. Serious uncontroled infections; 7. Diseases of CNS or psyche which affect congnition including CNS metastasis; 8. Serious allergy history; 9. Serious pulmonary heart disease for example: acute myocardial infarction shorter than 6 months or congestive heart failure or symptomatic angina, coagulative function abnormal etc.; 10. Female of pregnant and lactation or patients who reject contraceptional therapy during treatment period; 11. MRI/EBUS/CT suggest unresectable tumors; 12. Preexcisting incomplete or complete bowel obstruction related to rectal cancer; 13. Hereditary nonpolyposis colorectal cancer (HNPCC) and familial adenomatous polyposis(FAP).

Design outcomes

Primary

MeasureTime frame
5-years survival rate and OS;

Secondary

MeasureTime frame
3-years DFS;Operation related mortality and complication related mortality;Lymph notes detection rate;Operation time, blood loss, complication rates, length of hospital stay and costs;Recurrence within 3 years;

Countries

China

Contacts

Public ContactJin Gu
zlguj@yahoo.com.cn+86 10 88196238

Outcome results

None listed

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