Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma
This trial is active, not recruiting.
|Treatment||laparoscopic surgery for rectal carcinoma|
|Sponsor||Japan Society of Laparoscopic Colorectal Surgery|
|Start date||February 2008|
|End date||September 2015|
|Trial size||495 participants|
|Trial identifier||NCT00635466, Lap RC, NCCHCT19-49|
The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: 5 year
anastomotic leakage rate
time frame: 1 month
Male or female participants from 20 years up to 75 years old.
Inclusion Criteria: 1. Histologically proven rectal carcinoma. 2. Tumor located in the rectum. 3. Clinical Tis, T1, T2 N0 M0 4. Without multiple lesions other than carcinoma in situ 5. Tumor size <8 cm. 6. Sufficient organ function. 7. No bowel obstruction. 8. No history of major colorectal surgery. 9. No history of chemotherapy or radiotherapy. 10. Provide written informed consent. Exclusion Criteria: 1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ. 2. Pregnant or lactating women. 3. Severe mental disease. 4. Severe pulmonary emphysema, interstitial pneumonitis or ischemic heart disease. 5. Continuous systemic steroid therapy.
|Official title||Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma|
|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.|
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