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

Jvan Casarin, MD PhD

Status: Enrolling

Conditions: Early-stage Epithelial Ovarian Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06879730

55/2024

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

1,500 participants in 2 patient groups

Patients treated with minimally invasive approach

Patients treated with open surgery