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Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma — Lap RC  

Rectal Cancer Clinical Trial

Official title:
Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma

Clinical Trial Summary

The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma

Clinical Trial 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; however, controversy persists regarding the appropriateness of laparoscopic surgery for patients with rectal carcinoma because of the uncertainty of the long-term outcome, and of concerns over the safety of the procedure. In Japan, lateral lymph node dissection combined with total mesorectal excision remains the standard surgical procedure for patients with advanced lower rectal carcinoma, and lateral lymph node dissection by laparoscopy is still an unexplored frontier. To examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma, a phase II trial will be conducted in patients with a preoperative diagnosis of stage 0/I rectal carcinoma, under the direction of the Japan Society of Laparoscopic Colorectal Surgery, to which leading hospitals in laparoscopic surgery for colorectal carcinoma in Japan are members. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00635466
Study type Interventional
Source Japan Society of Laparoscopic Colorectal Surgery
Contact
Status Active, not recruiting
Phase Phase 2
Start date February 2008
Completion date September 2015
View Details
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