The Stress Response in Laparoscopic Colorectal Surgery and Its Role in the Development of the Enhanced Recovery Program.
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|ClinicalTrials.gov Identifier: NCT01128088|
Recruitment Status : Completed
First Posted : May 21, 2010
Last Update Posted : May 21, 2014
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|
|Study Type :||Observational|
|Actual Enrollment :||133 participants|
|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|
- The change in interleukin 6 levels following surgery for the four groups. [ Time Frame: Change detected between 0 and 6 hours post-operatively ]
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): NCT01128088
|The Royal Surrey County Hospital|
|Guildford, Surrey, United Kingdom, GU2 7XX|
|Study Director:||Tim Rockall, MBBS FRCS MD||Minimal Access Therapy Training Unit|