Condition category
Cancer
Date applied
10/06/2009
Date assigned
04/08/2009
Last edited
04/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pierpaolo Caputo

ORCID ID

Contact details

Via Alfieri 16
Milano
20154
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CDI-00301-2009

Study information

Scientific title

Epidural analgesia in video laparoscopic (VL) left hemicolectomy - optional and not mandatory choice in "Fast Track" treatment: a randomised controlled trial

Acronym

EAT IVA

Study hypothesis

Randomised trial conducted in order to quantify the concrete validity and limitations of intravenous patient-controlled analgesia therapy (IVA) versus epidural analgesic therapy (EAT) in "Fast Track" treatment of patients submitted to video laparoscopic left hemicolectomy.

Ethics approval

Ethics approval not required as the comparison in this trial was between two non-experimental procedures.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colorectal cancer

Intervention

After VL left hemicolectomy, patients would be provided analgesia in one of two ways: intravenous patient-controlled analgesia therapy (IVA) versus epidural analgesic therapy (EAT).

The following drugs were used:
IVA: Tramadol (400 mg/day), Ketoprofene (320 mg/day), Morphine (20 mg/day), Metoclopramide (20 mg/day), Ropivacaine cloridrate (12 - 28 mg/hour continuous infusion)
EAT: via epidural catheter (Naropine)

The average duration of treatment was 3.07 days for the IVA group and 4.05 days for the EAT group.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Pain control, measured with the Visual Analogue Scale (VAS) at day 0,1 and 2

Secondary outcome measures

1. Canalisation, measured daily
2. Drainage removal, measured daily

Overall trial start date

01/01/2007

Overall trial end date

30/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with neoplastic or recurrent flogistic pathology of the left colon
2. Patients with indication to VL surgery
3. Aged less than 18 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Patients over 80 years old
2. American Society of Anaesthesiologists (ASA) grade 4

Recruitment start date

01/01/2007

Recruitment end date

30/04/2009

Locations

Countries of recruitment

Italy

Trial participating centre

Via Alfieri 16
Milano
20154
Italy

Sponsor information

Organisation

Lecco Hospital Corporation (Azienda Ospedaliera Ospedale di Lecco) (Italy)

Sponsor details

Presidio di Merate Leopoldo Mandic
Merate
23900
Italy

Sponsor type

Hospital/treatment centre

Website

http://www.ospedale.lecco.it/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes