Ensayos clínicos

Inclusion Criteria:

• Patients will be registered into three distinct groupings, and each group will be analyzed as a separate study:
  • Patients who will undergo or have undergone hysterectomy/bilateral salpingo-oophorectomy (BSO) and pelvic lymphadenectomy +/- para-aortic node sampling via open or laparoscopic technique for clinical stage I-II or surgical stage I-III uterine carcinoma, including those receiving postoperative adjuvant therapy; patients enrolling after surgery may have a pathologic stage of I-III OR
  • Patients who will undergo or have undergone radical hysterectomy or trachelectomy and pelvic lymphadenectomy +/- para-aortic node sampling via open or laparoscopic technique for clinical stage IA-IIA cervical carcinoma, including those receiving postoperative adjuvant therapy OR
  • Patients with vulvar cancer who will undergo or have undergone definitive surgery for primary stage I-IV vulvar cancer who will or have received a radical vulvectomy or radical local excision with concurrent unilateral or bilateral inguinal or inguinal-femoral lymphadenectomy; patients who are going to receive multi-modality therapy (radiation +/-chemotherapy) after undergoing surgery are eligible; patients may undergo sentinel node mapping as long as it is followed by a full lymphadenectomy
• Patients must have signed an approved informed consent and authorization permitting release of personal health information
• Patients must have a serum albumin level of ≥ 3.0 within 14 days of entry
• Surgery must occur within 5 business days before study entry or within eight weeks after study entry

Exclusion Criteria:

• Patients with any prior clinical history of lower extremity lymphedema
• Patients who have a history of congestive heart failure, chronic renal disease, or chronic liver disease
• Patients with a prior history of chronic lower extremity swelling
• Patients with a Gynecologic Oncology Group (GOG) performance grade of 3 or 4
• Patients with a history of other invasive malignancies if their previous cancer treatment included any of the surgical procedures
• Patients who have had prior lower extremity vascular surgery (arterial or venous)
• Patients who have had prior pelvic, abdominal, inguinal, or lower extremity radiation therapy
• Patients who have had or are going to receive another elective surgery during the same operative event as their pelvic (cervical or uterine cancers) or inguinal (vulvar) lymphadenectomy
• Patients cannot be enrolled on the trial unless there is at least one person at the participating site who has been trained in performing limb measurements
• Patients who do not undergo or have not undergone the lymphadenectomy portion of the procedure
• Patients who enter the study and then undergo sentinel node biopsy without the intention of undergoing complete lymphadenectomy