Cytokine-guided Robotic Cystectomy (CY-ROC)

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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• United Kingdom
  • Hertfordshire
    • Stevenage, Hertfordshire, United Kingdom, SG14AB
      • Recruiting
      • East and North Hertfordshire NHS Trust
      • Contact: Nikhil Vasdev, ChM (Urol), FRCS (Urol); Phone Number: 01438 28 4042; Email: nikhil.vasdev@nhs.net
      • Contact: Alexander Hampson, MBBS; Phone Number: 01438 28 4042; Email: alexander.hampson@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing planned robotic radical cystectomy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between cytokine rise (intra-and post-operatively) and postoperative ileus following robotic radical cystectomy	Serum cytokine levels	24 hours post-surgery

Collaborators and Investigators

• Sponsor: East and North Hertfordshire NHS Trust
• Collaborators: University of Hertfordshire

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2018
• Primary Completion (Anticipated): June 14, 2022
• Study Completion (Anticipated): June 14, 2022

Study Registration Dates

• First Submitted: June 9, 2019
• First Submitted That Met QC Criteria: June 9, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: RD2018-65

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No