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Hand assisted laparoscopic surgery (HALS) versus open surgery in the treatment of sigmoid colon cancer and upper rectal cancer: a randomized control clinical trial of multiple centers

Hand assisted laparoscopic surgery (HALS) versus open surgery in the treatment of sigmoid colon cancer and upper rectal cancer: a randomized control clinical trial of multiple centers

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10001110
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

colorectal cancer

Interventions

B:Open surgery
A:HALS surgery

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Pathological diagnosis of colorectal cancer; 2. Resectable sigmoid colon cancer or upper rectum cancer; 3. Clinical staging lower than 4a; 4. no radiological metastasis; 5. No previous gastrointestinal surgery; 6. No pre-operative radiotherapy; 7. Without complete bowel obstruction; 8. good cardiopulmnoary functions; 9. Karnofsky score more than 70; 10. signature of informed consent; 11. Female patients in trails must under contraception. And patients who is menopause should be assureed for 12 months and pregnancy should be ruled out; 12. No other relevant diseases (tumors in other sites or serious disease heart or central nervous system, CNS); 13. WBC > 3.5*10^9/ml, PLT> 10*10^9/ml, T-Bil 50ml/min.

Exclusion criteria

Exclusion criteria: 1. uncontroled underlying diseases (unstable angina etc); 2. Previous history of immunosuppresive therapy (including corticosteroids therapy); 3. pre-operative radiotheraphy; 4. preexciting metastasis; 5. attending other relative clinial trials; 6. difficulty in endure anesthesia and surgery; 7. serious uncontroled infection; 8. Diseases of CNS or psyche which affect congnition including CNS metastasis; 9. Serious allergy history; 10. Serious pulmonary heart disease; 11. Female of pregnant and lactation or patients who reject contraceptional therapy during treatment period.

Design outcomes

Primary

MeasureTime frame
OS;Surgical complication;

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