Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma
Summary
The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for 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.
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Rectal Cancer
Intervention
laparoscopic surgery for rectal carcinoma
Location
Kitasato University Hospital
Sagamihara
Kanagawa
Japan
228-8555
Status
Recruiting
Source
Japan Society of Laparoscopic Colorectal Surgery
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00635466
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Rectal Neoplasms
Tumors or cancer of the RECTUM.
Salt Gland
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)
Rectal Prolapse
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.
Surgery, Computer-assisted
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.
Clinical Trials
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PubMed Articles
Short- and long-term impact of body mass index on laparoscopic rectal cancer surgery.
Aim Obesity is associated with increased technical difficulty in laparoscopic surgery. However, its impact has been measured mainly for colectomy but not specifically for rectal excision. The aim o...
Laparoscopic Versus Open Surgery for Stage I Rectal Cancer: Long-term Oncologic Outcomes.
BACKGROUND: Laparoscopic resection is increasingly being performed for rectal cancer. However, few data are available to compare long-term outcomes after open versus laparoscopic surgery for early-sta...
Laparoscopic surgery for rectal cancer: Review of published literature 2000-2009.
We reviewed seven reports of laparoscopic low anterior resection (LAR) alone for rectal cancer and 18 reports of laparoscopic surgery, including LAR. We examined the length of surgery, blood loss duri...
Laparoscopic surgery for rectal cancer: preoperative radiochemotherapy versus surgery alone.
BACKGROUND: A few studies have suggested advantages of laparoscopic surgery for rectal cancer. However, the role of laparoscopy has not been clearly defined specifically in cases...
