Real-World Outcomes of minimally invasive versus open surgery in early-stage ovarian and borderline tumors, ROMIO-trial

Real-World Outcomes of minimally invasive versus open surgery in early-stage ovarian and borderline tumors, ROMIO-trial - ROMIO-trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00040740

Enrollment

700

Registered

2026-06-25

Start date

2026-06-18

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Carcinoma

Interventions

Group 1: The planned study is designed as a retrospective observational study. All patients who underwent surgery for early-stage ovarian cancer or borderline ovarian tumors between 2019 and 2023 at p

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Early-stage malignant ovarian tumors (pT1–pT2, FIGO stage I–II, cM0) Borderline ovarian tumors Primary surgical treatment Surgery performed between January 2019 and December 2023

Exclusion criteria

Exclusion criteria: Ovarian metastases from other primary tumors Benign ovarian tumors Tumors treated with neoadjuvant systemic therapy prior to surgery

Design outcomes

Primary

Measure	Time frame
Disease-Free Survival (DFS): surgery date ? recurrence or death; censored at last follow-up 30-day morbidity: Clavien–Dindo grade = II (and separately grade = III)	—

Secondary

Measure	Time frame
Operative time, blood loss, transfusion requirement, conversion rate (for minimally invasive surgery [MIS]) Intraoperative and postoperative complications, reoperation, readmission (within 30 days) Length of hospital stay (LOS), ICU/Intermediate Care Unit (IMC) stay Overall Survival (OS): surgery date ? death Recurrence rate, time to recurrence, recurrence pattern Completeness of staging (yes/no; individual components) Upstaging rate Tumor rupture/spillage Guideline adherence (surgery ± adjuvant therapy) Time to initiation of adjuvant therapy (if indicated) Abbreviations DFS = Disease-Free Survival OS = Overall Survival LOS = Length of Stay ICU = Intensive Care Unit IMC = Intermediate Care Unit MIS = Minimally Invasive Surgery OP-Datum = Date of Surgery (or Operation Date)	—

Measure

Time frame

Operative time, blood loss, transfusion requirement, conversion rate (for minimally invasive surgery [MIS]) Intraoperative and postoperative complications, reoperation, readmission (within 30 days) Length of hospital stay (LOS), ICU/Intermediate Care Unit (IMC) stay Overall Survival (OS): surgery date ? death Recurrence rate, time to recurrence, recurrence pattern Completeness of staging (yes/no; individual components) Upstaging rate Tumor rupture/spillage Guideline adherence (surgery ± adjuvant therapy) Time to initiation of adjuvant therapy (if indicated) Abbreviations DFS = Disease-Free Survival OS = Overall Survival LOS = Length of Stay ICU = Intensive Care Unit IMC = Intermediate Care Unit MIS = Minimally Invasive Surgery OP-Datum = Date of Surgery (or Operation Date)

—

Countries

Austria, Germany

Contacts

Public ContactJan Niklas Winterer

Universitätsklinikum Essen

jan.winterer@uk-essen.de+49 201 723 86107

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026