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
KORE
1 other identifier
interventional
465
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 5, 2022
CompletedFirst Posted
Study publicly available on registry
February 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJanuary 15, 2025
January 1, 2025
3.5 years
January 5, 2022
January 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Severe postoperative complications Clavien Dindo Classification III-V
CDC III-V
up until postoperative day 60
Secondary Outcomes (11)
Postoperative complications Clavien Dindo Classification I-II
up until postoperative day 60
Postoperative morbidity
post-operative day 30, 60, 90
Length of hospital stay
up until postoperative day 90
Re-hospitalisation-rate
up until postoperative day 90
Hospital staff compliance
up until postoperative day 60
- +6 more secondary outcomes
Study Arms (4)
Control Group 1
NO INTERVENTIONHistoric 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.
Control Group 2
NO INTERVENTIONProspective 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.
Control Group 3
NO INTERVENTIONControl group for health economical analysis to determine the cost-effectiveness of the new intervention.
Intervention Group
EXPERIMENTALIntervention Group undergoing the new multi-modal perioperative care pathway, including the implementation of ERAS pathway, in combination with a tri-modal prehabilitation program following a comprehensive frailty assessment.
Interventions
The innovative multi-modal care pathway includes the implementation of the ERAS pathway, as well as the introduction of a patient-specific tri-modal prehabilitation program. This consists of a physical fitness, nutrition, and patient empowerment intervention.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Charite University, Berlin, Germanylead
- Kliniken Essen-Mittecollaborator
Study Sites (2)
Evangelische Kliniken Essen Mitte
Essen, North Rhine-Westphalia, 45136, Germany
Charité University Hospital Berlin
Berlin, State of Berlin, 13353, Germany
Related Publications (1)
Inci 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: 37208019DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician
Study Record Dates
First Submitted
January 5, 2022
First Posted
February 25, 2022
Study Start
July 1, 2020
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
January 15, 2025
Record last verified: 2025-01