Health Condition 1: X- New Technology
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Age 18 and above. 2. Patients with a high likelihood of having a malignant ovarian tumor planned for exploratory laparotomy 3. Patients referred with confirmed ovarian tumor after previous surgery ( unilateral or bilateral salpingo-oophrectomy with or without hysterectomy) , those in whom the ovarian malignant tumour has already been resected and a second surgical procedure is planned to complete the staging procedure including lymph nodes.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Previous vascular surgery of aorta,caval vein or iliac vessels 2. Previous lymphadenectomy or lymph node sampling in the iliac or paraortic region 3. History of malignant lymphoma 4. History of malignant tumor in abdominal cavity • Previous allergic reaction to blue dye or human albumin • Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| primary end objective is to report any adverse event related to the technique, as well as the feasibility of the techniqueTimepoint: 1-month ( 4 weeks) post procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| The second exploratory objectives are to report sensitivity, specificity, and the positive and negative predictive values of the technique, the detection rate and location of sentinel lymph nodesTimepoint: 4 weeks post procedure | — |
Countries
India
Contacts
Dr Bhubaneshwar Borooah Cancer Institute