Clinical trial NCT06879730: Retrospective Evaluation of Minimally-Invasive Surgical Strategies in Ovarian Neoplasms (REMISSION Study)
Official title: Retrospective Evaluation of Minimally-Invasive Surgical Strategies in Ovarian Neoplasms (REMISSION Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Early-stage Epithelial Ovarian Cancer
Keywords: early-stage epithelial ovarian cancer
minimally invasive surgery
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 1500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The current study is a retrospective multicentric international observational study of data from patients with apparent early-stage epithelial ovarian cancer who underwent minimally-invasive or open surgery between January 2014 and December 2023.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patients with apparent early-stage epithelial ovarian cancer at preoperative evaluation
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:

1. Patients who have not performed a complete surgical staging
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

Primary outcomes:
measure: To assess the number of patients with 30-day post-operative complication in the two groups (minimally invasive surgery and open surgery)
timeFrame: From surgery to post-operative day 30
measure: To assess the number of patients with 30-day post-operative hospital readmission in the two groups (minimally invasive surgery and open surgery)
timeFrame: From surgery to post-operative day 30
measure: To assess the number of patients with 30-day post-operative reoperation in the two groups (minimally invasive surgery and open surgery)
timeFrame: From surgery to post-operative day 30
measure: To assess the rate of upstaging in the two groups (minimally invasive surgery and open surgery)
timeFrame: At the time of surgery
measure: To assess the rate of conversion in the minimally invasive surgery group
timeFrame: At the time of surgery
Secondary outcomes:
measure: 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
timeFrame: 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
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Ospedale Filippo del Ponte
Study officials:
References: