Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm
18 Years
75 Years
Female
Stage IIIC Ovarian Cancer
Trial Information
Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm
Inclusion Criteria:
- Patients with suspected advanced ovarian cancer (FIGO stage IIIC)
- PIV ≥ 8, PIV ≤ 12
- Estimated life expectancy of at least 4 weeks.
- PS ≤ 2
- Appropriate respiratory, hepatic, cardiological, bone marrow and renal functions
(Creatinine Clearance > 60 mL/min according to Cockcroft formula)
- Patient capable of consent.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- Non-appropriate respiratory, hepatic, cardiological, bone marrow and renal functions
- Large size mass reaching the xiphoid, occupying all the abdominal cavity and/or
infiltrating the abdominal wall.
- Mesenteric retraction
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Outcome Measure:
Evaluation and comparison of early surgical complications of primary surgery and Interval debulking surgery.
Outcome Description:
Early surgical complications: Blood transfusion Re-laparotomy suture dehiscence of laparotomy. Venous thrombosis Haemorrhage Death in the post-operative period Digestive fistula Urinary fistula Lymphocyst Fever Infection Pleural effusion Pulmonary embolism Pneumothorax Pneumonia
Outcome Time Frame:
thirty days
Safety Issue:
Yes
Authority:
Italy: Ethics Committee
Study ID:
789/11
NCT ID:
NCT01461850
Start Date:
September 2011
Completion Date:
September 2013
Related Keywords:
- Stage IIIC Ovarian Cancer
- Neoplasms
- Ovarian Neoplasms
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