Condition category
Cancer
Date applied
21/08/2008
Date assigned
02/10/2008
Last edited
09/01/2014
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

Mr Michael Lewis

ORCID ID

Contact details

Norfolk and Norwich University Hospital NHS Foundation Trust
Department of General Surgery
Centre Block
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
+44 (0)1603 287583
Michael.Lewis@nnuh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SUR011(48-04-07)

Study information

Scientific title

A randomised, observer-blinded clinical trial of post-operative fluid restriction in elective gastrointestinal surgery

Acronym

Study hypothesis

The null hypothesis is that intravenous peri- and post-operative fluid restriction does not affect the rate of complications in the first 30 days following major gastrointestinal surgery.

Ethics approval

Norfolk Research Ethics Committee gave approval on the 5th September 2007 (ref: SUR011 [48-04-07])

Study design

Randomised, observer-blinded 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

Upper gastrointestinal and colorectal cancer resection

Intervention

A restricted intra- and post-operative fluid regime with the use of ephedrine instead of fluids once losses have been replaced in the event of hypotension as opposed to a standard regime of fluid replacement. All patients will have epidurals for pain relief.

Intervention type

Drug

Phase

Not Specified

Drug names

Ephedrine

Primary outcome measures

Grade II complications and above up to 30 days post-surgery.

Secondary outcome measures

1. 30 day post-operative mortality
2. Length of hospital stay
3. Post-operative hypotensive episodes. Duration of follow-up: 5 days post-operatively.

Overall trial start date

01/10/2007

Overall trial end date

01/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. All adult patients (both males and females) undergoing elective colorectal or upper gastrointestinal surgery (gastrectomies, oesophagectomies) cancer resection at the Norfolk and Norwich University Hospital NHS Foundation Trust
2. All patients will have epidurals for pain relief

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

234

Participant exclusion criteria

1. American Society of Anaesthesiologists (ASA) classification 4 - 5
2. Chronic renal failure defined as a creatinine greater than 140 μmol/L
3. Congestive cardiac failure defined as New York Heart Association (NYHA) class III - IV
4. Pregnancy
5. Diabetes mellitus (excluding diet controlled)
6. Planned post-operative ventilation on intensive treatment unit (ITU)
7. Contraindication to epidural
8. Inability to give informed consent

Recruitment start date

01/10/2007

Recruitment end date

01/01/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich
NR4 7UY
United Kingdom

Sponsor information

Organisation

Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)

Sponsor details

Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom

Sponsor type

Government

Website

http://www.nnuh.nhs.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0706-10478)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24227358

Publication citations

  1. Results

    Kalyan JP, Rosbergen M, Pal N, Sargen K, Fletcher SJ, Nunn DL, Clark A, Williams MR, Lewis MP, Randomized clinical trial of fluid and salt restriction compared with a controlled liberal regimen in elective gastrointestinal surgery., Br J Surg, 2013, 100, 13, 1739-1746, doi: 10.1002/bjs.9301.

Additional files

Editorial Notes