Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery - Full Text View

Sponsored by:	Minimal Access Therapy Training Unit
Information provided by:	Minimal Access Therapy Training Unit
ClinicalTrials.gov Identifier:	NCT00747292

Purpose

The aim is to ascertain which method out of epidural, spinal or patient controlled analgesia (PCA) is the most appropriate in fluid optimised patients after laparoscopic colorectal surgery in terms of pain control, length of hospital stay and time for gut recovery. The second aim is to assess the physiological changes that occur when the patient is placed in steep trendelenberg position together with the creation of the pneumoperitoneum.

Condition	Intervention	Phase
Neoplasm Diverticular Disease Analgesia	Procedure: epidural Procedure: PCA Procedure: Spinal	Phase I Phase II

MedlinePlus related topics: Cancer Nausea and Vomiting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Randomised Controlled Trial Comparing the Effects of Epidural, Spinal and PCA in Patients Undergoing Laparoscopic Colectomy.

Further study details as provided by Minimal Access Therapy Training Unit:

Primary Outcome Measures:

Length of hospital stay [ Time Frame: Once the patient is safe to go home ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pain, time till flatus, time till bowels open, incidence of nausea and vomiting, quality of life [ Time Frame: Once secondary outcomes are successful, patient can go home ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	99
Study Start Date:	December 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Epidural: Active Comparator Epidural	Procedure: epidural Patients in this limb receive epidural analgesia
2: Active Comparator Spinal	Procedure: Spinal Patients in limb will receive spinal analgesia
3: Active Comparator Patients in this limb receive a PCA	Procedure: PCA Patients in this limb receive a PCA for their pain control

Detailed Description:

Patients will be randomized into one of 3 groups - A, B or C. In order to remove the major confounding factor of hypovolaemia, all patients will have an oesophageal doppler inserted in order to achieve fluid optimisation. Each group will then either have an epidural, spinal or a PCA for post operative analgesia depending on the randomisation. All patients will follow a common postoperative care pathway to standardize the other factors.

Patients will be asked to report parameters including pain visual analogue score (VAS) chart three times a day. Recovery of bowel functions (passage of flatus, bowel movement, and diet intake), additional analgesia consumption, time to first ambulation, analgesia related side-effects and time to discharge will be recorded.

In addition whilst the patients fluid status is optimized during surgery with the oesophageal Doppler, the physiological changes that occur with the steep trendelenberg position and the pneumoperitoneum will be recorded.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with colorectal disease that requires a bowel resection who agree to have laparoscopic surgery with placement of an oesophageal doppler and a central line and who agree to be randomised with regards to a post operative analgesic regime.

Exclusion Criteria:

Patients will be excluded from the post operative analgesia trial if they have abnormal clotting, skin infection over or near the back, presence of neurological disorders or anatomical abnormalities of the vertebral column, or for a reason identified by the anaesthetist.
Patients will also be excluded if there is a contra-indication to oesophageal doppler such as oesophageal disease, recent oesophageal or upper airway surgery, moderate to severe aortic valve disease and bleeding diathesis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747292

Contacts

Contact: Bruce F Levy, MRCS

07769656842

brucelevy22@hotmail.com

Locations

United Kingdom, Surrey
MATTU	Recruiting
Guildford, Surrey, United Kingdom, GU2 9PS
Contact: Bruce F Levy, MRCS 07769656842 brucelevy22@hotmail.com
Principal Investigator: Bruce F Levy, MRCS

Sponsors and Collaborators

Minimal Access Therapy Training Unit

Investigators

Study Director:

Tim Rockall, FRCS

Minimal Access Therapy Training Unit

More Information

Publications:

Senagore AJ, Delaney CP, Mekhail N, Dugan A, Fazio VW. Randomized clinical trial comparing epidural anaesthesia and patient-controlled analgesia after laparoscopic segmental colectomy. Br J Surg. 2003 Oct;90(10):1195-9.

Senagore AJ, Whalley D, Delaney CP, Mekhail N, Duepree HJ, Fazio VW. Epidural anesthesia-analgesia shortens length of stay after laparoscopic segmental colectomy for benign pathology. Surgery. 2001 Jun;129(6):672-6.

Taqi A, Hong X, Mistraletti G, Stein B, Charlebois P, Carli F. Thoracic epidural analgesia facilitates the restoration of bowel function and dietary intake in patients undergoing laparoscopic colon resection using a traditional, nonaccelerated, perioperative care program. Surg Endosc. 2007 Feb;21(2):247-52. Epub 2006 Dec 9.

Kong SK, Onsiong SM, Chiu WK, Li MK. Use of intrathecal morphine for postoperative pain relief after elective laparoscopic colorectal surgery. Anaesthesia. 2002 Dec;57(12):1168-73.

Responsible Party:	MATTU ( Bruce Levy )
Study ID Numbers:	07/H1111/70
Study First Received:	September 4, 2008
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00747292
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Minimal Access Therapy Training Unit:

laparoscopic
colon
analgesia
fluid optimised

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Diverticulum

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 14, 2009