ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer

Summary

ULTRA-LAP is a prospective study is to investigate the safety, efficacy and feasibility of laparoscopic debulking surgery (LDS) for the treatment of patients with advanced ovarian cancer. The outcomes to measure are: * Safety: the rate of patients experiencing intra- and post-operative early and late morbidities (within the hospitalization and up to 60 days from surgery) * Efficacy: the rate of patients in which the surgical target set pre-operatively (complete resection) is achieved by laparoscopy. * Feasibility: the rate of patients who have their procedure completed by laparoscopy Patients will undergo laparoscopic debulking surgery (LDS) if the surgical target can be met. If it cannot be achieved by laparoscopy the surgeon will convert to laparotomy.

Eligibility

Inclusion Criteria:

* Patients with advanced epithelial ovarian cancer (II-IV Stage FIGO) candidates to PDS (primary debulking surgery) or IDS (interval debulking surgery: neoadjuvant chemotherapy followed by IDS).
* Participant is willing and able to give informed consent for participation in the study.
* Female aged 18 years or above.
* Primary diagnosis of advanced epithelial ovarian cancer (tubal and peritoneal cancer included).

Exclusion Criteria:

* Comorbidities non-allowing for radical surgery
* Poor Performance Status (Karnofsky Index \< 70)
* Concomitant or past history of malignancy, regardless of treatment status
* Recent or past story of pancreatitis or hepatitis
* Recent or past story of pleural effusion or lung injuries or respiratory failure
* Cardiac major pathologies

Conditions2

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