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Clinical impact of early enteral versus parenteral nutrition following cystectomy and extended pelvic lymphadenectomy
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 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22695241
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 18/07/2013
Date ISRCTN assigned 07/07/2010
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