NCT05256576Completed
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 · Last updated 15 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 465 (actual)
- First submitted
- 5 Jan 2022
- Start date
- 1 Jul 2020
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Charite University, Berlin, Germany
- Diseases
- Ovarian cancer
- NCT number
- NCT05256576
What you commit to
- Study type: Interventional
- Participants enrolled: 465
- From 1 Jul 2020 to the primary completion date, 31 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- neoadjuvant chemotherapy
Other illness
- simultaneous diagnosis of secondary primary tumors (except for breast cancer)
- dementia or other psychological diseases, that impair comprehence and compliance
Other
- inoperable situs
- pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charite - University Hospital Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Evangelische Kliniken-Essen-Mitte Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.