Retrospective Evaluation of Minimally-Invasive Surgical Strategies in Ovarian Neoplasms (REMISSION Study)
NCT ID: NCT06879730
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2024-05-15
2027-10-31
Brief Summary
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1. Post-Surgery Complications
* What is the rate of complications within 30 days after surgery?
* How often do patients require readmission to the hospital, re-operation, or conversion to open surgery?
2. Cancer Outcomes
* What is the rate of cancer upstaging (when the cancer spreads to a more advanced stage during surgery for example because of an intra-operative ovarian cyst rupture)?
* What are the overall survival and disease-free survival rates for patients treated with minimally invasive surgery?
Researchers will compare two groups of patients:
Group 1: Patients with early-stage ovarian cancer treated with minimally invasive surgery.
Group 2: Patients with early-stage ovarian cancer treated with open surgery. The goal is to see if there are any differences in post-surgery complications, recovery, and cancer outcomes between the two groups.
Fertility-Sparing Treatment:
The study will also compare patients who are undergoing fertility-sparing treatments for early-stage ovarian cancer. Two subgroups will be looked at:
* Patients receiving fertility-sparing surgery through a minimally invasive procedure.
* Patients receiving fertility-sparing surgery through an open surgery. The same outcomes (complications, survival, etc.) will be assessed and compared between these two groups as well.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Patients treated with minimally invasive approach
No interventions assigned to this group
Patients treated with open surgery
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Patients who underwent surgery between January 2014 and December 2023
3. Patients who underwent open or minimally invasive surgical staging (Laparoscopic or Robotic-assisted approach) or restaging procedure
4. Patients with final pathology report of Epithelial Ovarian Cancer
Exclusion Criteria
2. Patients who underwent neoadjuvant chemotherapy
3. Patients with invasive synchronous tumor
4. Patients with no informed consent
5. Patients with ASA class score of 4 or 5
FEMALE
No
Sponsors
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Jvan Casarin, MD PhD
OTHER
Responsible Party
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Jvan Casarin, MD PhD
Associate Professor of Obstetrics and Gynecology Director, Research Center for Gynecologic Oncology and Minimally Invasive Surgery, University of Insubria, OB/GYN Consultant
Locations
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Ospedale Filippo del Ponte
Varese, Varese, Italy
Countries
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Central Contacts
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Anna Giudici, Medical Doctor
Role: CONTACT
Facility Contacts
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Other Identifiers
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55/2024
Identifier Type: -
Identifier Source: org_study_id
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