NCT05862740Recruiting
ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer
ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer: a Feasibility Prospective Study
Source: ClinicalTrials.gov · Last updated 17 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 10 Mar 2023
- Start date
- 2 Jan 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Azienda Ospedaliera di Padova
- Diseases
- Ovarian cancer
- NCT number
- NCT05862740
What you commit to
- Study type: Interventional
- Planned participants: 62
- From 2 Jan 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Comorbidities non-allowing for radical surgery
Other illness
- 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
Other
- Poor Performance Status (Karnofsky Index \< 70)
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliera Universitaria di Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.