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Spots Global Cancer Trial Database for Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery

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We do not endorse or review these studies in any way.

Trial Identification

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 ID: NCT00747292

Interventions

epidural
PCA
Spinal

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

MATTU, Guildford, Surrey, United Kingdom

Contact Details

Name: Tim Rockall, FRCS

Affiliation: Minimal Access Therapy Training Unit

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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