Status:
UNKNOWN
Trial to Evaluate Laparoscopic Versus Open Surgery in Elderly Colorectal Cancer Patients
Lead Sponsor:
Shoichi Fujii, MD, PhD
Conditions:
Colorectal Cancer
Eligibility:
All Genders
75+ years
Phase:
PHASE3
Brief Summary
Elderly patients have poorer preoperative conditions than younger patients. Therefore, minimally invasive surgery should be an effective treatment method for elderly patients. The investigators conduc...
Detailed Description
Patients * This was a randomized controlled trial conducted at a single institute, which was Yokohama City University Medical Center (Japan). * 200 patients were age of 75 years old or over were rand...
Eligibility Criteria
Inclusion
- Age of 75 years old or over
- Histologically proven adenocarcinoma
- Clinical tumor penetrates visceral peritoneum (T4a), no metastasis (M0) or lower T factor
- Elective operation
- Tolerable surgery under general anesthesia
- No bulky tumor larger than 8cm in diameter
- No history of laparotomy for colorectal resection except appendectomy
- Provided written informed consent
Exclusion
- Synchronous or metachronous (within 5 years) malignancy in another organ except carcinoma in situ
- Multiple colorectal cancer that needs reconstruction two or more times
- Acute intestinal obstruction or perforation due to colorectal cancer
- Lower rectal cancer that required pelvic side wall lymphadenectomy
- Pregnant or lactating women
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01862562
Start Date
August 1 2008
End Date
August 1 2017
Last Update
November 26 2013
Active Locations (1)
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1
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan, 232-0024