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
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)
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...
Single-incision laparoscopic surgery (SILS) may represent an improvement over conventional laparoscopic surgery, and has been applied in many surgical procedures. However, for pancreatic surgery, expe...
Although laparoscopic surgery for colon cancer is accepted in the treatment guidelines, the laparoscopic approach for rectal cancer is recommended only in clinical trials. Thus far, several trials hav...
Single-incision laparoscopic appendectomy has emerged as a less invasive alternative to conventional laparoscopic surgery. High-quality relevant evidence is limited.
► Robotic surgery offers several advantages in the management of endometrial cancer. ► No long-term data exist regarding recurrence in patients undergoing robotic surgery. ► Metastasis or recurr...
The aim of the study was to compare short- and long-term outcomes of laparoscopic surgery and conventional open surgery for colorectal cancer.