Retrospective Evaluation of Minimally-Invasive Surgical Strategies in Ovarian Neoplasms (REMISSION Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Early-stage Epithelial Ovarian Cancer. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This observational study aims to evaluate the outcomes of patients with early-stage epithelial ovarian cancer who are treated with minimally invasive surgery (such as laparoscopic or robotic surgery). Specifically, the study will look at: 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.
Primary outcome measures
- To assess the number of patients with 30-day post-operative complication in the two groups (minimally invasive surgery and open surgery) [Time frame: From surgery to post-operative day 30]
- To assess the number of patients with 30-day post-operative hospital readmission in the two groups (minimally invasive surgery and open surgery) [Time frame: From surgery to post-operative day 30]
- To assess the number of patients with 30-day post-operative reoperation in the two groups (minimally invasive surgery and open surgery) [Time frame: From surgery to post-operative day 30]
- To assess the rate of upstaging in the two groups (minimally invasive surgery and open surgery) [Time frame: At the time of surgery]
- To assess the rate of conversion in the minimally invasive surgery group [Time frame: At the time of surgery]
Secondary outcome measures (1)
- To analyze predictor of recurrence and oncological outcomes in terms of disease-free survival (DFS) and overall survival (OS) in the minimally invasive surgery and in the open surgery groups [Time frame: From the date of surgery to the date of the last follow-up or the date of recurrence/death, whichever occurs first, assessed up to 300 weeks]
Eligibility criteria
Inclusion criteria
- Patients with apparent early-stage epithelial ovarian cancer at preoperative evaluation
- Patients who underwent surgery between January 2014 and December 2023
- Patients who underwent open or minimally invasive surgical staging (Laparoscopic or Robotic-assisted approach) or restaging procedure
- Patients with final pathology report of Epithelial Ovarian Cancer
Exclusion criteria
- Patients who have not performed a complete surgical staging
- Patients who underwent neoadjuvant chemotherapy
- Patients with invasive synchronous tumor
- Patients with no informed consent
- Patients with ASA class score of 4 or 5
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- Ospedale Filippo del Ponte — Varese
Identifiers
NCT: NCT06879730 · 55/2024