Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm Diverticular Disease Analgesia||Procedure: epidural Procedure: PCA Procedure: Spinal||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Epidural
Patients in this limb receive epidural analgesia
Active Comparator: 2
Patients in limb will receive spinal analgesia
Active Comparator: 3
Patients in this limb receive a PCA
Patients in this limb receive a PCA for their pain control
- Length of hospital stay [ Time Frame: Once the patient is safe to go home ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT00747292
|Contact: Bruce F Levy, MRCSemail@example.com|
|Guildford, Surrey, United Kingdom, GU2 9PS|
|Contact: Bruce F Levy, MRCS 07769656842 firstname.lastname@example.org|
|Principal Investigator: Bruce F Levy, MRCS|
|Study Director:||Tim Rockall, FRCS||Minimal Access Therapy Training Unit|