Cytokine-guided Robotic Cystectomy
CY-ROC
Diagnostic Accuracy of Increased Serum Cytokine Levels as a Marker of Paralytic Ileus Following Robotic Radical Cystectomy
1 other identifier
observational
20
1 country
1
Brief Summary
There is a recognised complication of surgery known as a 'Paralytic Ileus', where bowel function is reduced after an operation, causing an obstruction and resulting in nausea and vomiting. This complication is more common in patients that have robotic surgery due to the positioning required and the gas pressures required for keyhole/robotic surgery. While some of the factors involved in a paralytic ileus are known, the full mechanism and the chemicals involved are not yet fully understood. This study is looking at the level of specific chemicals called 'cytokines', and the changes in the level of these cytokines in the blood before and after robotic surgery, specifically during bladder removal (cystectomy). Cytokine levels will be compared against post-operative recovery and whether a paralytic ileus is developed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2018
Typical duration for all trials
1 active site
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
December 17, 2018
CompletedFirst Submitted
Initial submission to the registry
June 9, 2019
CompletedFirst Posted
Study publicly available on registry
June 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2022
CompletedDecember 16, 2020
December 1, 2020
3.5 years
June 9, 2019
December 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation between cytokine rise (intra-and post-operatively) and postoperative ileus following robotic radical cystectomy
Serum cytokine levels
24 hours post-surgery
Eligibility Criteria
Patients undergoing planned robotic radical cystectomy
You may qualify if:
- Patients aged between 40 and 75 years of age
- Patients undergoing a Robotic radical cystectomy
- Patient consenting to enter the study
- Patients consenting for blood samples for cytokine analysis
You may not qualify if:
- Patients \<40 years of age and patients \>75 years of age
- Patients unwilling or unable to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire, SG14AB, United Kingdom
Biospecimen
Blood samples
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2019
First Posted
June 11, 2019
Study Start
December 17, 2018
Primary Completion
June 14, 2022
Study Completion
June 14, 2022
Last Updated
December 16, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share