|
ISRCTN
|
ISRCTN79535150
|
|
DOI
|
10.1186/ISRCTN79535150
|
|
ClinicalTrials.gov identifier
|
|
|
EudraCT number
|
|
|
Public title
|
Clinical impact of early enteral versus parenteral nutrition following cystectomy and extended pelvic lymphadenectomy
|
|
Scientific title
|
Clinical impact of early enteral versus parenteral nutrition following cystectomy evaluated in a prospective randomised trial
|
|
Acronym
|
N/A
|
|
Serial number at source
|
160/10
|
|
Study hypothesis
|
Current opinion favours the use of postoperative early enteral over parenteral nutrition, although the benefits in cystectomy patients have never been clearly shown. The aim of this study is to evaluate the clinical impact of early enteral versus total parenteral nutrition following cystectomy.
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
The Ethics Committee of the Canton of Bern (Ethikkommission des Kantons Bern) approved originally in November 2007. The trial was not started and approval was re-sought and granted in May 2010 (ref: 1394)
|
|
Study design
|
Prospective single centre double blind randomised trial
|
|
Countries of recruitment
|
Switzerland
|
|
Disease/condition/study domain
|
Bladder cancer / invasive disease / Urology
|
|
Participants - inclusion criteria
|
1. Consecutive series of 198 patients with invasive bladder cancer scheduled for cystectomy and extended pelvic lymph node dissection
2. Age >18 years
|
|
Participants - exclusion criteria
|
1. Age <18y
2. Pregnancy
3. No informed consent available
4. Previous radiotherapy to the pelvis
5. Prior bowel surgery
|
|
Anticipated start date
|
01/07/2010
|
|
Anticipated end date
|
01/03/2012
|
|
Status of trial
|
Stopped |
|
Patient information material
|
Not available in web format, please use contact details below to request a patient information sheet [in German]
|
|
Target number of participants
|
198
|
|
Interventions
|
After cystectomy and extended pelvic lymphadenectomy patients are randomized into one of the following groups:
1. Group A: parenteral nutrition is given for 7 days; oral intake with a gastrostomy tube in place is started on day 4 after surgery
2. Group B: oral food is given the first day after surgery. No parenteral nutrition. Saline solution for volume substitution
|
|
Primary outcome measure(s)
|
Occurrence of postoperative complications according to the Dindo-Clavien classification with particular respect for infections. Measured within the first 30 days after surgery
|
|
Secondary outcome measure(s)
|
1. Recovery of bowel function (flatulence, passage of stool, nausea, vomiting)
2. Length of postoperative hospital stay
3. Nutritional biochemical variables
3.1. Serum albumin
3.2. Prealbumin
3.3. Total protein
Measured by questionnaire and blood samples on postoperative day 1, 3, 7, 10, 14 and 30 days after surgery.
|
|
Sources of funding
|
Inselspital, University Hospital Berne (Switzerland) - Urology Department (Urologische Universitätsklinik)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Beat
Roth
|
|
Address
|
Inselspital
Urology Department (Urologische Universitätsklinik)
|
|
City/town
|
Bern
|
|
Zip/Postcode
|
3010
|
|
Country
|
Switzerland
|
|
Sponsor
|
Inselspital, University Hospital Berne (Switzerland)
|
|
Address
|
Urology Department (Urologische Universitätsklinik)
|
|
City/town
|
Bern
|
|
Zip/Postcode
|
3010
|
|
Country
|
Switzerland
|
|
Date applied
|
25/06/2010
|
|
Last edited
|
26/06/2012
|
|
Date ISRCTN assigned
|
07/07/2010
|
