Cytokine-guided Robotic Cystectomy (CY-ROC)
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|ClinicalTrials.gov Identifier: NCT03982498|
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
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.
|Condition or disease|
Cytokines are signalling proteins that are release by immune cells in response to stress on the body. In this study the aim is to evaluate the concordance between cytokine rise (specifically monitoring the following cytokines: Interferon (IFN)-gamma, tumour necrosis factor (TNF)-alpha, Interleukin (IL) -1beta, IL-2, IL-4, IL-6, IL-12 and IL-17) and postoperative ileus (a condition where bowel function slows causing build up of faecal matter) following robotic radical cystectomy and the pneumoperitoneum (gas insufflation of the abdomen) pressures that were required intra-operatively.
This study includes patients undergoing radical cystectomy. The study will measure pre-anaesthetic, post-anaesthetic, immediately post-operatively and two further post-operative serum cytokines levels and compare them with the pneumoperitoneal pressures required intra-operatively and the outcome of whether a clinical diagnosis of paralytic ileus was made.
Serum cytokine levels will be taken on five occasions:
- st Sample (Baseline)-Before induction of anaesthetic
- nd Sample-Immediately after induction of anaesthetic
- rd Sample-Immediately post-operative
- th Sample - 2 hours post-operative
- th Sample - 1 day post-operative
No alterations will be made to the care of the patient, this is purely an observational study.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Diagnostic Accuracy of Increased Serum Cytokine Levels as a Marker of Paralytic Ileus Following Robotic Radical Cystectomy|
|Actual Study Start Date :||December 17, 2018|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||January 1, 2020|
- Correlation between cytokine rise (intra-and post-operatively) and postoperative ileus following robotic radical cystectomy [ Time Frame: 24 hours post-surgery ]Serum cytokine levels
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982498
|Contact: Nikhil Vasdev, ChM (Urol), FRCS (Urol)||01438 28 firstname.lastname@example.org|
|Contact: Alexander Hampson, MBBS||01438 28 email@example.com|
|East and North Hertfordshire NHS Trust||Recruiting|
|Stevenage, Hertfordshire, United Kingdom, SG14AB|
|Contact: Nikhil Vasdev, ChM (Urol), FRCS (Urol) 01438 28 4042 firstname.lastname@example.org|
|Contact: Alexander Hampson, MBBS 01438 28 4042 email@example.com|