Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma
NCT00635466 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 495
Last updated 2011-06-16
Summary
The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma
Conditions
Interventions
- PROCEDURE
-
laparoscopic surgery for rectal carcinoma
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).
Sponsors & Collaborators
-
Japan Society of Laparoscopic Colorectal Surgery
lead NETWORK
Principal Investigators
-
Masahiko Watanabe, PhD · Kitasato University Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-02-29
- Primary Completion
- 2015-09-30
- Completion
- 2015-09-30
Countries
- Japan
Study Locations
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