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The Stress Response in Laparoscopic Colorectal Surgery and Its Role in the Development of the Enhanced Recovery Program.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01128088
Recruitment Status : Completed
First Posted : May 21, 2010
Last Update Posted : May 21, 2014
Information provided by (Responsible Party):
University of Surrey

Brief Summary:

Keyhole bowel surgery provides the patient with an improved outcome following surgery in comparison to more traditional surgery requiring a large cut. In order to further improve outcomes there are several variables that must be controlled before, during and after the operation. These variables are the correct pain relief, accurate control and measurement of the fluid that is given during the operation and the subsequent mobility following surgery. Previous research has already identified that an enhanced recovery program (careful control and structure to the patients journey) will reduce the length of stay and complications after an operation. Currently an integral part of the enhanced recovery program requires the use of an epidural (a thin tube in the spine) to provide continuous pain relief for up to 48 hours. Through research previously undertaken at the MATTU the investigators have shown that an epidural can lead to an increase in the length of stay and a delay in the return to normal bowel function. A reason for the use of an epidural is to suppress the stress response.

The investigators aim to recruit patients from outpatient clinic undergoing keyhole bowel surgery in one unit and randomize them to receive one of two different pain relief methods after the operation. Patients will follow the same care as standard patients but their pain relief will differ between two already well established modalities. They will also receive different intravenous fluids. Blood will also be drawn at various intervals immediately after the operation for future analysis. The trial will be funded by the MATTU and will run for approximately 18 months. This trial will enable us to establish the stress response in the four groups and correlate it to the patient's outcome with an aim to refining the enhanced recovery program.

Condition or disease
Laparoscopy Colorectal Disease Stress Response

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Study Type : Observational
Actual Enrollment : 133 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Stress Response in Laparoscopic Colorectal Surgery and Its Role in the Development of the Enhanced Recovery Program.
Study Start Date : March 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : January 2012

PCA and Volulyte
PCA and Hartmann's
Spinal and Volulyte
Spinal and Hartmann's

Primary Outcome Measures :
  1. The change in interleukin 6 levels following surgery for the four groups. [ Time Frame: Change detected between 0 and 6 hours post-operatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients having colorectal resections at The Royal Surrey County Hospital

Inclusion Criteria:

  • Colonic or rectal resection procedure.

Exclusion Criteria:

  • Stoma formation (previous research at the MATTU has shown that the formation of a stoma significantly affects the quality of life to the degree that there is no difference between open and laparoscopic surgery)

    • Conversion to a traditional open operation (removes the elements of keyhole surgery)
    • Contraindication to spinal anaesthesia: abnormal clotting, skin infection over or near the back, presence of neurological disorders or anatomical abnormalities of the vertebral column. (For patient safety)
    • Contraindication to the use of oesophageal Doppler: oesophageal disease, recent oesophageal surgery or upper airway surgery, moderate to severe aortic valve disease and any condition that causes bleeding problems. (For patient safety)
    • Diagnosis of diabetes mellitus (will confound the stress response analysis)
    • Treatment with exogenous steroids in the proceeding 3 months (will confound the stress response analysis)

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 identifier (NCT number): NCT01128088

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United Kingdom
The Royal Surrey County Hospital
Guildford, Surrey, United Kingdom, GU2 7XX
Sponsors and Collaborators
University of Surrey
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Study Director: Tim Rockall, MBBS FRCS MD Minimal Access Therapy Training Unit

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Surrey Identifier: NCT01128088    
Other Study ID Numbers: SURGN0008
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014
Keywords provided by University of Surrey:
Enhanced recovery program in laparoscopic surgery