Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma
The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
laparoscopic surgery for rectal carcinoma
Kitasato University Hospital
Japan Society of Laparoscopic Colorectal Surgery
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00635466
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Tumors or cancer of the RECTUM.
A compound tubular gland, located around the eyes and nasal passages in marine animals and birds, the physiology of which figures in water-electrolyte balance. The Pekin duck serves as a common research animal in salt gland studies. A rectal gland or rectal salt gland in the dogfish shark is attached at the junction of the intestine and cloaca and aids the kidneys in removing excess salts from the blood. (Storer, Usinger, Stebbins & Nybakken: General Zoology, 6th ed, p658)
Protrusion of the rectal mucous membrane through the anus. There are various degrees: incomplete with no displacement of the anal sphincter muscle; complete with displacement of the anal sphincter muscle; complete with no displacement of the anal sphincter muscle but with herniation of the bowel; and internal complete with rectosigmoid or upper rectum intussusception into the lower rectum.
Surgical procedures conducted with the aid of computers. This is most frequently used in orthopedic and laparoscopic surgery for implant placement and instrument guidance. Image-guided surgery interactively combines prior CT scans or MRI images with real-time video.
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Reply to: doi:10.1007/s0046-4-010-1485-0: Re: Evaluation of factors affecting the difficulty of laparoscopic anterior resection for rectal cancer: "narrow pelvis" is not a contraindication (Surg Endosc 2011 Jan;25:1907-1912) : What factors should be consi