Actively Recruiting
ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer
Led by Azienda Ospedaliera di Padova · Updated on 2023-05-17
62
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliera di Padova
Lead Sponsor
U
University of Padova
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with advanced epithelial ovarian cancer (stage II-IV FIGO) eligible for primary or interval debulking surgery
- Willing and able to give informed consent to participate in the study
- Female aged 18 years or older
- Primary diagnosis of advanced epithelial ovarian cancer including tubal and peritoneal cancer
You will not qualify if you...
- Having medical conditions that prevent radical surgery
- Poor overall health status with Karnofsky Index below 70
- Current or past history of any other cancer
- Recent or past pancreatitis or hepatitis
- Recent or past pleural effusion, lung injuries, or respiratory failure
- Major heart diseases
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Trial Site Locations
Total: 1 location
1
Azienda Ospedaliera Universitaria di Padova,
Padova, Padova, Veneto, Italy, 35128
Actively Recruiting
Research Team
M
Matteo Marchetti, Doctor
CONTACT
M
Marco Noventa, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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