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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
Sponsor:
Collaborator:
University of Hertfordshire
Information provided by (Responsible Party):
East and North Hertfordshire NHS Trust

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.


Condition or disease
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.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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
Blood samples


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing planned robotic radical cystectomy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982498


Contacts
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Contact: Nikhil Vasdev, ChM (Urol), FRCS (Urol) 01438 28 4042 nikhil.vasdev@nhs.net
Contact: Alexander Hampson, MBBS 01438 28 4042 alexander.hampson@nhs.net

Locations
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United Kingdom
East and North Hertfordshire NHS Trust Recruiting
Stevenage, Hertfordshire, United Kingdom, SG14AB
Contact: Nikhil Vasdev, ChM (Urol), FRCS (Urol)    01438 28 4042    nikhil.vasdev@nhs.net   
Contact: Alexander Hampson, MBBS    01438 28 4042    alexander.hampson@nhs.net   
Sponsors and Collaborators
East and North Hertfordshire NHS Trust
University of Hertfordshire

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Responsible Party: East and North Hertfordshire NHS Trust
ClinicalTrials.gov Identifier: NCT03982498     History of Changes
Other Study ID Numbers: RD2018-65
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No