Overview

This trial is active, not recruiting.

Condition rectal cancer
Treatment laparoscopic surgery for rectal carcinoma
Phase phase 2
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

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients undergoing laparoscopic surgery for rectal carcinoma
laparoscopic surgery for rectal carcinoma laparoscopic rectal resection
Laparoscopic resection of the rectum with adequate lymphadenectomy is performed according to the General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus edited by the Japanese Society for Cancer of the Colon and Rectum. The extent of lymphadenectomy and site of ligation and division of the inferior mesenteric vessels were decided by the surgeon in charge. Pneumoperitoneal approaches are used to explore the abdomen, mobilize the left side colon, identify critical structures and ligate the vascular pedicle. Mobilization of the rectum, excision of the mesorectum, rectal transection, removal of the specimen, and reconstruction are performed by the pneumoperitoneal approach or the extracorporeal approach via a small incision (<8 cm).

Primary Outcomes

Measure
overall survival
time frame: 5 year

Secondary Outcomes

Measure
anastomotic leakage rate
time frame: 1 month

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Japan Society of Laparoscopic Colorectal Surgery.