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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of Surrey.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Surrey
ClinicalTrials.gov Identifier:
NCT01128088
First received: May 20, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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
Laparoscopy
Colorectal Disease
Stress Response

Study Type: Observational
Study Design: 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.

Further study details as provided by University of Surrey:

Primary Outcome Measures:
  • The change in interleukin 6 levels following surgery for the four groups. [ Time Frame: Change detected between 0 and 6 hours post-operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: March 2010
Groups/Cohorts
PCA and Volulyte
PCA and Hartmann's
Spinal and Volulyte
Spinal and Hartmann's

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients having colorectal resections at The Royal Surrey County Hospital

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128088

Contacts
Contact: Andrew R Day, MBBS MRCS 00441483688691 dayandrew@hotmail.co.uk

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

No publications provided

Responsible Party: Director of MATTU, MATTU, University of Surrey
ClinicalTrials.gov Identifier: NCT01128088     History of Changes
Other Study ID Numbers: SURGN0008
Study First Received: May 20, 2010
Last Updated: May 20, 2010
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Surrey:
Enhanced recovery program in laparoscopic surgery

ClinicalTrials.gov processed this record on April 17, 2014