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

NCT01128088 | Completed

• 1 other identifier: SURGN0008
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopy; Colorectal Disease; Stress Response

Keywords

Enhanced recovery program in laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• The change in interleukin 6 levels following surgery for the four groups.

  Change detected between 0 and 6 hours post-operatively

Study Arms (4)

PCA and Volulyte

PCA and Hartmann's

Spinal and Volulyte

Spinal and Hartmann's

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients having colorectal resections at The Royal Surrey County Hospital

You may qualify if:

• Colonic or rectal resection procedure.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Surrey: lead

Study Sites (1)

The Royal Surrey County Hospital

Guildford, Surrey, GU2 7XX, United Kingdom

Location

Related Publications (1)

• Day AR, Smith RV, Scott MJ, Fawcett WJ, Rockall TA. Randomized clinical trial investigating the stress response from two different methods of analgesia after laparoscopic colorectal surgery. Br J Surg. 2015 Nov;102(12):1473-9. doi: 10.1002/bjs.9936. Epub 2015 Sep 23.

  PMID: 26395762 DERIVED

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Tim Rockall, MBBS FRCS MD

  Minimal Access Therapy Training Unit

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 21, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

GB (1)