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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01128088
Other study ID # SURGN0008
Secondary ID
Status Completed
Phase N/A
First received May 20, 2010
Last updated May 20, 2014
Start date March 2010
Est. completion date January 2012

Study information

Verified date May 2014
Source University of Surrey
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 133
Est. completion date January 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom The Royal Surrey County Hospital Guildford Surrey

Sponsors (1)

Lead Sponsor Collaborator
University of Surrey

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The change in interleukin 6 levels following surgery for the four groups. Change detected between 0 and 6 hours post-operatively No
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