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NCT Number: NCT06879730

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

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.

Recruiting

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Key information

Conditions

Early-stage Epithelial Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. To assess the rate of upstaging in the two groups (minimally invasive surgery and open surgery)

    Time frame: At the time of surgery

  5. To assess the rate of conversion in the minimally invasive surgery group

    Time frame: At the time of surgery

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Giudici, Medical Doctor

CONTACT

+39 3317099194

Jvan Casarin, Medical Doctor

CONTACT

[email protected]

+39 3335384990

Sponsors and collaborators

Lead sponsor

Jvan Casarin, MD PhD

Other

Registry information

Acronym: REMISSION

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 17, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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