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Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00747292
Recruitment Status : Unknown
Verified September 2008 by Minimal Access Therapy Training Unit.
Recruitment status was:  Recruiting
First Posted : September 5, 2008
Last Update Posted : September 5, 2008
Information provided by:
Minimal Access Therapy Training Unit

Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasm Diverticular Disease Analgesia Procedure: epidural Procedure: PCA Procedure: Spinal Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial Comparing the Effects of Epidural, Spinal and PCA in Patients Undergoing Laparoscopic Colectomy.
Study Start Date : December 2007
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : October 2009

Arm Intervention/treatment
Active Comparator: Epidural
Procedure: epidural
Patients in this limb receive epidural analgesia

Active Comparator: 2
Procedure: Spinal
Patients in limb will receive spinal analgesia

Active Comparator: 3
Patients in this limb receive a PCA
Procedure: PCA
Patients in this limb receive a PCA for their pain control

Primary Outcome Measures :
  1. Length of hospital stay [ Time Frame: Once the patient is safe to go home ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00747292

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Contact: Bruce F Levy, MRCS 07769656842

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United Kingdom
MATTU Recruiting
Guildford, Surrey, United Kingdom, GU2 9PS
Contact: Bruce F Levy, MRCS    07769656842   
Principal Investigator: Bruce F Levy, MRCS         
Sponsors and Collaborators
Minimal Access Therapy Training Unit
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Study Director: Tim Rockall, FRCS Minimal Access Therapy Training Unit
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Responsible Party: Bruce Levy, MATTU Identifier: NCT00747292    
Other Study ID Numbers: 07/H1111/70
First Posted: September 5, 2008    Key Record Dates
Last Update Posted: September 5, 2008
Last Verified: September 2008
Keywords provided by Minimal Access Therapy Training Unit:
fluid optimised
Additional relevant MeSH terms:
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Diverticular Diseases
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical