Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery
Primary Purpose
Neoplasm, Diverticular Disease, Analgesia
Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
epidural
PCA
Spinal
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasm focused on measuring laparoscopic, colon, analgesia, fluid optimised
Eligibility 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.
Sites / Locations
- MATTURecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Epidural
2
3
Arm Description
Epidural
Spinal
Patients in this limb receive a PCA
Outcomes
Primary Outcome Measures
Length of hospital stay
Secondary Outcome Measures
Pain, time till flatus, time till bowels open, incidence of nausea and vomiting, quality of life
Full Information
NCT ID
NCT00747292
First Posted
September 4, 2008
Last Updated
September 4, 2008
Sponsor
Minimal Access Therapy Training Unit
1. Study Identification
Unique Protocol Identification Number
NCT00747292
Brief Title
Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery
Official Title
Randomised Controlled Trial Comparing the Effects of Epidural, Spinal and PCA in Patients Undergoing Laparoscopic Colectomy.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
October 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Minimal Access Therapy Training Unit
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm, Diverticular Disease, Analgesia
Keywords
laparoscopic, colon, analgesia, fluid optimised
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epidural
Arm Type
Active Comparator
Arm Description
Epidural
Arm Title
2
Arm Type
Active Comparator
Arm Description
Spinal
Arm Title
3
Arm Type
Active Comparator
Arm Description
Patients in this limb receive a PCA
Intervention Type
Procedure
Intervention Name(s)
epidural
Intervention Description
Patients in this limb receive epidural analgesia
Intervention Type
Procedure
Intervention Name(s)
PCA
Intervention Description
Patients in this limb receive a PCA for their pain control
Intervention Type
Procedure
Intervention Name(s)
Spinal
Intervention Description
Patients in limb will receive spinal analgesia
Primary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
Once the patient is safe to go home
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruce F Levy, MRCS
Phone
07769656842
Email
brucelevy22@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Rockall, FRCS
Organizational Affiliation
Minimal Access Therapy Training Unit
Official's Role
Study Director
Facility Information:
Facility Name
MATTU
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 9PS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce F Levy, MRCS
Phone
07769656842
Email
brucelevy22@hotmail.com
First Name & Middle Initial & Last Name & Degree
Bruce F Levy, MRCS
12. IPD Sharing Statement
Citations:
PubMed Identifier
14515286
Citation
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. doi: 10.1002/bjs.4223.
Results Reference
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PubMed Identifier
11391364
Citation
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. doi: 10.1067/msy.2001.114648.
Results Reference
background
PubMed Identifier
17160649
Citation
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. doi: 10.1007/s00464-006-0069-5. Epub 2006 Dec 9.
Results Reference
background
PubMed Identifier
12437707
Citation
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. doi: 10.1046/j.1365-2044.2002.02873.x.
Results Reference
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Learn more about this trial
Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery
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