Clinical trial NCT03982498: Cytokine-guided Robotic Cystectomy
Official title: Diagnostic Accuracy of Increased Serum Cytokine Levels as a Marker of Paralytic Ileus Following Robotic Radical Cystectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Lead sponsor: East and North Hertfordshire NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Hertfordshire
First posted: 2019-06-11
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing planned robotic radical cystectomy

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.

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.

Eligibility 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

Primary outcomes:
measure: Correlation between cytokine rise (intra-and post-operatively) and postoperative ileus following robotic radical cystectomy
timeFrame: 24 hours post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Stevenage
country: United Kingdom
facility: East and North Hertfordshire NHS Trust
state: Hertfordshire
Study officials:
References: