Retrospective Evaluation of Minimally-Invasive Surgical Strategies in Ovarian Neoplasms (REMISSION Study)

NCT ID: NCT06879730

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-15

Study Completion Date

2027-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Early-stage Epithelial Ovarian Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jvan Casarin, MD PhD

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

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

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ospedale Filippo del Ponte

Varese, Varese, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jvan Casarin, Medical Doctor

Role: CONTACT

+39 3335384990

Anna Giudici, Medical Doctor

Role: CONTACT

+39 3317099194

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jvan Casarin, MD, PhD

Role: primary

+39 0332299309

Anna Giudici, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

55/2024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.