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

NCT05862740 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2023-05-17

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Laparoscopic Debulking Surgery in advanced ovarian cancer

Laparoscopic debulking will be conducted until the surgical target is achieved or the operation is converted to laparotomy.

PROCEDURE

Standard laparotomic Debulking Surgery in advanced ovarian cancer

Debulking by laparotomy in patients when debulking could not be accomplished by laparoscopy.

Sponsors & Collaborators

  • University of Padova

    collaborator OTHER

  • Azienda Ospedaliera di Padova

    lead OTHER

Principal Investigators

  • Roberto Tozzi, Professor · Azienda Ospedale Università di Padova

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-02
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05862740 on ClinicalTrials.gov