Status:
UNKNOWN
Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma
Lead Sponsor:
Japan Society of Laparoscopic Colorectal Surgery
Conditions:
Rectal Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma
Detailed Description
Recently reported randomized controlled trials demonstrated that laparoscopic surgery was comparable or superior to open surgery regarding the long-term outcome for colon and rectosigmoidal carcinoma;...
Eligibility Criteria
Inclusion
- Histologically proven rectal carcinoma.
- Tumor located in the rectum.
- Clinical Tis, T1, T2 N0 M0
- Without multiple lesions other than carcinoma in situ
- Tumor size \<8 cm.
- Sufficient organ function.
- No bowel obstruction.
- No history of major colorectal surgery.
- No history of chemotherapy or radiotherapy.
- Provide written informed consent.
Exclusion
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
- Pregnant or lactating women.
- Severe mental disease.
- Severe pulmonary emphysema, interstitial pneumonitis or ischemic heart disease.
- Continuous systemic steroid therapy.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
495 Patients enrolled
Trial Details
Trial ID
NCT00635466
Start Date
February 1 2008
End Date
September 1 2015
Last Update
June 16 2011
Active Locations (1)
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1
Kitasato University Hospital
Sagamihara, Kanagawa, Japan, 228-8555