Cytokine-guided Robotic Cystectomy

Cancer Clinical Trial

— CY-ROC  

Official title:

Diagnostic Accuracy of Increased Serum Cytokine Levels as a Marker of Paralytic Ileus Following Robotic Radical Cystectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03982498
• Other study ID #: RD2018-65
• Status: Recruiting
• Start date: December 17, 2018
• Est. completion date: June 14, 2022

Study information

• Verified date: December 2020
• Source: East and North Hertfordshire NHS Trust
• Contact: Nikhil Vasdev, ChM (Urol), FRCS (Urol)
• Phone: 01438 28 4042
• Email: nikhil.vasdev[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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:

1. st Sample (Baseline)-Before induction of anaesthetic

2. nd Sample-Immediately after induction of anaesthetic

3. rd Sample-Immediately post-operative

4. th Sample - 2 hours post-operative

5. th Sample - 1 day post-operative

No alterations will be made to the care of the patient, this is purely an observational study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 14, 2022
• Est. primary completion date: June 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients <40 years of age and patients >75 years of age

• Patients unwilling or unable to consent

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United Kingdom	East and North Hertfordshire NHS Trust	Stevenage	Hertfordshire

Sponsors (2)

Lead Sponsor	Collaborator
East and North Hertfordshire NHS Trust	University of Hertfordshire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between cytokine rise (intra-and post-operatively) and postoperative ileus following robotic radical cystectomy	Serum cytokine levels	24 hours post-surgery