Clinical trial · Interventional
KORE-INNOVATION: a Prospective, Multi-site Clinical Trial to Implement and Analyse the Effects of an Innovative Perioperative Care Pathway to Reduce Complications for Patients with Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
KORE-INNOVATION is a multi-center clinical study aiming to implement and analyze an innovative care pathway to reduce perioperative complications for patients undergoing surgical treatment for ovarian cancer. This is achieved by a structured, multidisciplinary implementation of the ERAS pathway, as well as introducing a tri-modal prehabilitation program, following a comprehensive frailty-assessment. The patient-individualized prehabilitation program consists of a structured plan to improve physical fitness, nutritional status, as well as patient empowerment. The aim of the study is to reduce perioperative morbidity and mortality, as well as improvement in quality of life.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Frailty | — | UNRESOLVED | — |
| Ovary Cancer | — | UNRESOLVED | — |
| Peritoneum Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Implementation of an innovative multi-modal peri-operative care pathway | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Control Group 1
- description
- Historic control group from both study sites: patients who took part in the FRAILTY study at Charité University hospital Berlin, as well as patients who were treated for OC at Evangelische Kliniken Essen Mitte during the same time period. Retrospective analysis looking at some of the main outcome variables will be conducted.
- type
- NO_INTERVENTION
- label
- Control Group 2
- description
- Prospective control group: patients who undergo treatment for OC at both sites. Main outcomes are determined while under standard hospital care before start of the change management and implementation of the new intervention.
- type
- NO_INTERVENTION
- label
- Control Group 3
- description
- Control group for health economical analysis to determine the cost-effectiveness of the new intervention.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women with primary diagnosis of ovarian, fallopian tube or peritoneal cancer and primary surgical treatment (all histological subgtypes, all FIGO-stages) * women with first recurrence of ovarian, fallopian tube or peritoneal cancer and primary surgical treatment (all histological subgtypes, all FIGO-stages) * patients who have given and signed informed consent-forms Exclusion Criteria: * inoperable situs * neoadjuvant chemotherapy * simultaneous diagnosis of secondary primary tumors (except for breast cancer) * dementia or other psychological diseases, that impair comprehence and compliance * pregnancy
References
Publications (1)
- DERIVEDInci MG, Sehouli J, Schnura E, Lee M, Roll S, Reinhold T, Klews J, Kaufner L, Niggemann P, Groeben H, Toelkes J, Reisshauer A, Liebl M, Daehnert E, Zimmermann M, Knappe-Drzikova B, Rolker S, Nunier B, Algharably E, Pirmorady Sehouli A, Zwantleitner L, Krull A, Heitz F, Ataseven B, Chekerov R, Harter P, Schneider S. The KORE-INNOVATION trial, a prospective controlled multi-site clinical study to implement and assess the effects of an innovative peri-operative care pathway for patients with ovarian cancer: rationale, methods and trial design. Int J Gynecol Cancer. 2023 Aug 7;33(8):1304-1309. doi: 10.1136/ijgc-2023-004531. PMID 37208019