Status:
UNKNOWN
Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum
Lead Sponsor:
Fujian Medical University
Collaborating Sponsors:
Sixth Affiliated Hospital, Sun Yat-sen University
Nanfang Hospital, Southern Medical University
Conditions:
Rectal Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety and oncological feasibility of laparoscopy-assisted surgery for low rectal carcinoma compared with open surgery.
Eligibility Criteria
Inclusion
- histologically proven rectal adenocarcinoma
- inferior edge of the tumor located within 5 cm from the dentate line as determined by rigid proctoscopy
- diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection or extralevator abdominoperineal excision
- T3-4a,N0 or T1-4a,N1-2 treated with neoadjuvant chemoradiotherapy
- no evidence of distant metastases
- tumor size \<6cm
- sufficient organ function
- no contraindication to laparoscopic surgery
- without other malignancies in medical history
Exclusion
- concurrent or previous diagnosis of invasive cancer within 5 years
- locally advanced cancers requiring en bloc multivisceral resection
- intestinal obstruction
- intestinal perforation
- history of colorectal surgery
- American Society of Anesthesiologists(ASA) class 4 or 5
- pregnant or breast-feeding women
- history of mental disorder
- participation in another rectal cancer clinical trial relating to surgical technique
Key Trial Info
Start Date :
November 12 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2023
Estimated Enrollment :
1070 Patients enrolled
Trial Details
Trial ID
NCT01899547
Start Date
November 12 2013
End Date
June 6 2023
Last Update
October 1 2021
Active Locations (1)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001