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

Phase 2

• Conditions: Rectal Cancer

• Registration Number: NCT00635466
• Lead Sponsor: Japan Society of Laparoscopic Colorectal Surgery

Brief Summary

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

Detailed 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 Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-06
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-13
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-15
• Last Update Posted: 2011-06-16
• Primary Completion: 2015-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 495

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
overall survival	5 year

Secondary Outcome Measures

Name	Time	Method
anastomotic leakage rate	1 month

Trial Locations

Locations (1)

Kitasato University Hospital; 🇯🇵 Sagamihara, Kanagawa, Japan