RecruitingNot ApplicableNCT05862740

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

Sponsor

Azienda Ospedaliera di Padova

Enrollment

62 participants

Start Date

Jan 2, 2022

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (ULTRA-LAP) evaluates whether laparoscopic (keyhole) surgery for debulking advanced ovarian cancer — removing as much tumor as possible — is feasible, safe, and effective compared to traditional open surgery. **You may be eligible if...** - You are a woman 18 years or older - You have been diagnosed with advanced epithelial ovarian, fallopian tube, or peritoneal cancer (stage II–IV) - You are a candidate for either primary surgery or surgery after initial chemotherapy - You are willing to participate and can give informed consent **You may NOT be eligible if...** - You have other serious medical conditions that prevent major surgery - Your general physical condition is too poor for surgery (Karnofsky Index below 70) - You have had or currently have another cancer - You have had pancreatitis, hepatitis, serious lung problems, or major heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELaparoscopic Debulking Surgery in advanced ovarian cancer

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

PROCEDUREStandard laparotomic Debulking Surgery in advanced ovarian cancer

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

Locations(1)

Azienda Ospedaliera Universitaria di Padova,

Padova, Padova, Veneto, Italy

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NCT05862740

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