Condition category
Cancer
Date applied
07/09/2009
Date assigned
28/10/2009
Last edited
27/11/2015
Prospective/Retrospective
Prospectively 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

Mr Nader Francis

ORCID ID

Contact details

Yeovil District Hospital
Higher Kingston
Yeovil
BA21 4AT
United Kingdom

Additional identifiers

EudraCT number

2009-014375-50

ClinicalTrials.gov number

Protocol/serial number

1.7

Study information

Scientific title

Comparison of the efficacy of thoracic Epidural analgesia and a local anaesthetic Wound Infusion Catheter after laparoscopic colectomy within the Enhanced Recovery Programme: a pilot randomised controlled trial (RCT)

Acronym

E-WIC

Study hypothesis

Wound infusion catheter is at least as effective as epidural following laparoscopic colectomy within the Enhanced Recovery Programme.

Ethics approval

South West Research Ethics Committee, 01/02/2010, ref: 09/H0206/66

Study design

Pilot 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

Laparoscopic colectomy within an enhanced recovery programme

Intervention

Patients recruited from colorectal outpatient clinic will be randomised to receive either epidural or wound infusion catheter.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Patient reported pain assessment. This will be assessed at baseline before the operation, on return to the ward after surgery and twice daily at 10.00 and 16.00 on days one and two post operatively. It will then be measured once daily until discharge and in outpatient follow up two weeks post operation.

Secondary outcome measures

1. Rescue analgesia. Analgesia log will be filled in daily by research nurse
2. Patient reported outcomes will be recorded pre operatively as baseline and prior to discharge by the research nurse using a structured questionnaire
3. Quality of life assessment using SF-36® Health Survey and Euroqol EQ-5D at baseline, prior to discharge and at two week follow up
4. A subset of 10 patients will be invited to take part in video recorded interviews at two week follow up to assess the success of blinding and to investigate the patient experience of taking part
5. Complications will be entered into a data sheet at discharge by the research fellow and followed up to 30 days to capture readmission, morbidity and mortality
6. Length of hospital stay will be recorded by the research nurse at discharge
7. Standard performance indicators using short physical performance battery will be assessed by the research nurse at baseline and 48 hours post operatively
8. Stress response to surgery and the effect of analgesic method will be investigated with blood samples taken at baseline, 3, 6, 12 and 24 hours after surgery. This will be performed by the research fellow or on call doctor to a strict protocol. The samples will measure epinephrine, cortisol, insulin and interleukin-6.

Overall trial start date

29/11/2009

Overall trial end date

07/02/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, aged 18 or over
2. Patients undergoing elective laparoscopic colectomy for right or left sided benign or malignant tumour of the colon, with intention to cure
3. American Society of Anesthesiology score of I, II or III
4. Able to provide written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Transverse colon or rectal tumour
2. Locally advanced (T4) or widespread distant disease. Palpable mass.
3. Emergency admission or obstruction/perforated disease
4. Inflammatory bowel disease (Crohn's Disease or Ulcerative Colitis)
5. Known allergy to local anaesthetic
6. Multiple sclerosis or chronic pain requiring regular strong opiate drugs
7. Recent history of drug or alcohol abuse
8. Contraindication to epidural
9. Poor cognitive ability making consent or completion of questionnaires impossible
10. Pregnant women

Recruitment start date

01/04/2010

Recruitment end date

01/04/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Yeovil District Hospital
Yeovil
BA21 4AT
United Kingdom

Sponsor information

Organisation

Yeovil District Hospital NHS Foundation Trust (UK)

Sponsor details

Yeovil District Hospital
Higher Kingston
Yeovil
BA21 4AT
United Kingdom

Sponsor type

Government

Website

http://www.yeovilhospital.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23254324

Publication citations

Additional files

Editorial Notes

27/11/2015: Publication reference added.