ULTRA-LAP Trial: Laparoscopic Debulking Surgery (LDS) in Advanced Ovarian Cancer: a Feasibility Prospective Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Italy
Azienda Ospedaliera Universitaria di Padova,
RECRUITING
Padua
Contact Information
Primary
Matteo Marchetti, Doctor
matteomarchetti91@gmail.com
0039-049-8213445
Backup
Marco Noventa, Doctor
marco.noventa@gmail.com
0039-049-8213445
Time Frame
Start Date: 2022-01-02
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 62
Treatments
Experimental: Laparoscopic debulking surgery - LDS
Primary debulking surgery or Interval debulking surgery performed by laparoscopy (P-LDS and I-LDS)
Active_comparator: Debulking surgery - DS
Primary debulking surgery or Interval debulking surgery performed by/converted to laparotomy (PDS and IDS)
Related Therapeutic Areas
Sponsors
Collaborators: University of Padova
Leads: Azienda Ospedaliera di Padova

This content was sourced from clinicaltrials.gov