MedDataX Logo

Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery

NCT ID: NCT00747292

Last Updated: 2008-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasm Diverticular Disease Analgesia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

laparoscopic colon analgesia fluid optimised

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Epidural

Epidural

Group Type ACTIVE_COMPARATOR

epidural

Intervention Type PROCEDURE

Patients in this limb receive epidural analgesia

2

Spinal

Group Type ACTIVE_COMPARATOR

Spinal

Intervention Type PROCEDURE

Patients in limb will receive spinal analgesia

3

Patients in this limb receive a PCA

Group Type ACTIVE_COMPARATOR

PCA

Intervention Type PROCEDURE

Patients in this limb receive a PCA for their pain control

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

epidural

Patients in this limb receive epidural analgesia

Intervention Type PROCEDURE

PCA

Patients in this limb receive a PCA for their pain control

Intervention Type PROCEDURE

Spinal

Patients in limb will receive spinal analgesia

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Minimal Access Therapy Training Unit

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

MATTU

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tim Rockall, FRCS

Role: STUDY_DIRECTOR

Minimal Access Therapy Training Unit

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

MATTU

Guildford, Surrey, United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Bruce F Levy, MRCS

Role: CONTACT

Phone: 07769656842

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bruce F Levy, MRCS

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 14515286 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11391364 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17160649 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12437707 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

07/H1111/70

Identifier Type: -

Identifier Source: org_study_id