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Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Minimal Access Therapy Training Unit.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Minimal Access Therapy Training Unit
ClinicalTrials.gov Identifier:
NCT00747292
First received: September 4, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Active Comparator: Epidural
Epidural
Procedure: epidural
Patients in this limb receive epidural analgesia
Active Comparator: 2
Spinal
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Bruce F Levy, MRCS 07769656842 brucelevy22@hotmail.com

Locations
United Kingdom
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