ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer
ConditionOvarian Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAzienda Ospedaliera di Padova
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Laparoscopic Debulking Surgery in advanced ovarian cancer
- Standard laparotomic Debulking Surgery in advanced ovarian cancer
Treatment groups
62 Participants
are divided into 2 treatment groupsSponsors and collaborators
Azienda Ospedaliera di Padova
Lead sponsor
University of Padova
Collaborator
Source ClinicalTrials.gov