Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus
RATIONALE: Laparoscopic surgery is a less invasive type of surgery for cancer of the uterus and may have fewer side effects and improve recovery. It is not known whether laparoscopic surgery is more effective than standard surgery in treating endometrial cancer.
PURPOSE: This randomized phase III trial is studying laparoscopic surgery to see how well it works compared to standard surgery in treating patients with endometrial cancer or cancer of the uterus.
- Compare the incidence of surgical complications, peri-operative morbidity, and mortality in patients with stage I or IIa, grade I-III endometrial cancer or uterine cancer undergoing surgical staging through laparoscopic assisted vaginal hysterectomy vs total abdominal hysterectomy.
- Compare the length of hospital stay after surgery in patients receiving these treatments.
- Compare the quality of life of patients receiving these treatments.
- Compare the incidence and location of disease recurrence in patients receiving these treatments.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo vaginal hysterectomy and bilateral salpingo- oophorectomy (BSO) via laparoscopy.
- Arm II: Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.
Patients in both arms also undergo pelvic and para-aortic lymph node sampling. Quality of life is assessed at baseline, at 1, 3, and 6 weeks, and then at 6 months.
Patients are followed at 6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 2,550 patients will be accrued for this study within at least 10 years.
Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment
conventional surgery, laparoscopic surgery
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
National Cancer Institute (NCI)
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00002706
- Information obtained from ClinicalTrials.gov on July 15, 2010
RATIONALE: Laparoscopic-assisted surgery is a less invasive type of surgery for colorectal cancer and may have fewer side effects and improve recovery. It is not yet known if undergoing co...
RATIONALE: Robotic-assisted laparoscopic surgery may be a less invasive type of surgery for rectal cancer and may have fewer side effects and improve recovery. It is not yet known whether ...
The standard procedure for treating colonic cancer is changing from open surgery to laparoscopic surgery. Following open colonic surgery patients are fatigued and loss body mass and have a...
COLOR trial is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of colon carcinoma with curative intent. Clinical and opera...
In many countries the gold standard for treating abdominal aortic aneurysms is still open surgery with a long incision. In patients with suitable anatomy alternatively an endovascular appr...
Surgical treatment for locally recurrent rectal cancer is challenging, and the value of laparoscopic surgery in such cases is unknown. The purpose of this study was to compare the feasibility of lapar...
The aim of this pooled analysis is to determine the effect of single-incision laparoscopic colorectal surgery (SILC) on short-term clinical and oncological outcomes compared with conventional multipor...
To evaluate the safety and short-term outcomes of laparoscopic-assisted surgery for rectal cancer by comparing the efficacy of laparoscopy and open surgery.
Potential benefits of single-port laparoscopic surgery may include improved cosmetic results, less postoperative pain, surgical trauma and faster recovery. Results of randomized prospective studies wi...
The development of new medical electronic devices and equipment has increased the use of electrical apparatuses in surgery. Many studies have reported the association of long-term exposure to extremel...
Medical and Biotech [MESH] Definitions
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.
Procedures that avoid use of open invasive surgery in favor of closed or local surgery. These generally involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an endoscope or similar device. With the reduced trauma associated with minimally invasive surgery, long hospital stays may be reduced with increased rates of short stay or day surgery.
Surgery which could be postponed or not done at all without danger to the patient. Elective surgery includes procedures to correct non-life-threatening medical problems as well as to alleviate conditions causing psychological stress or other potential risk to patients, e.g., cosmetic or contraceptive surgery.
Endoscopic surgical procedures performed with visualization via video transmission. When real-time video is combined interactively with prior CT scans or MRI images, this is called image-guided surgery (see SURGERY, COMPUTER-ASSISTED).
A board-certified specialty of VETERINARY MEDICINE, requiring at least four years of special education, training, and practice of veterinary surgery after graduation from veterinary school. In the written, oral, and practical examinations candidates may choose either large or small animal surgery. (From AVMA Directory, 43d ed, p278)