Condition category
Cancer
Date applied
25/06/2010
Date assigned
07/07/2010
Last edited
18/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Beat Roth

ORCID ID

Contact details

Inselspital
Urology Department (Urologische Universitätsklinik)
Bern
3010
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

160/10

Study information

Scientific title

Clinical impact of early enteral versus parenteral nutrition following cystectomy evaluated in a prospective randomised trial

Acronym

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.

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

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 contact details below to request a patient information sheet [in German]

Condition

Bladder cancer / invasive disease / Urology

Intervention

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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/07/2010

Overall trial end date

01/03/2012

Reason abandoned

Objectives no longer viable

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

198

Participant exclusion criteria

1. Age <18y
2. Pregnancy
3. No informed consent available
4. Previous radiotherapy to the pelvis
5. Prior bowel surgery

Recruitment start date

01/07/2010

Recruitment end date

01/03/2012

Locations

Countries of recruitment

Switzerland

Trial participating centre

Inselspital
Bern
3010
Switzerland

Sponsor information

Organisation

Inselspital, University Hospital Berne (Switzerland)

Sponsor details

Urology Department (Urologische Universitätsklinik)
Bern
3010
Switzerland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Inselspital, University Hospital Berne (Switzerland) - Urology Department (Urologische Universitätsklinik)

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/22695241

Publication citations

  1. Results

    Roth B, Birkhäuser FD, Zehnder P, Thalmann GN, Huwyler M, Burkhard FC, Studer UE, Parenteral nutrition does not improve postoperative recovery from radical cystectomy: results of a prospective randomised trial., Eur. Urol., 2013, 63, 3, 475-482, doi: 10.1016/j.eururo.2012.05.052.

Additional files

Editorial Notes