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Cytokine-guided Robotic Cystectomy

NCT ID: NCT03982498

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-17

Study Completion Date

2022-06-14

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Hertfordshire

OTHER

Sponsor Role collaborator

East and North Hertfordshire NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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East and North Hertfordshire NHS Trust

Stevenage, Hertfordshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Nikhil Vasdev, ChM (Urol), FRCS (Urol)

Role: CONTACT

Phone: 01438 28 4042

Email: [email protected]

Alexander Hampson, MBBS

Role: CONTACT

Phone: 01438 28 4042

Email: [email protected]

Facility Contacts

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Nikhil Vasdev, ChM (Urol), FRCS (Urol)

Role: primary

Alexander Hampson, MBBS

Role: backup

Other Identifiers

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RD2018-65

Identifier Type: -

Identifier Source: org_study_id