Clinical impact of early enteral versus parenteral nutrition following cystectomy and extended pelvic lymphadenectomy
| ISRCTN | ISRCTN79535150 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79535150 |
| Secondary identifying numbers | 160/10 |
- Submission date
- 25/06/2010
- Registration date
- 07/07/2010
- Last edited
- 18/07/2013
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Beat Roth
Scientific
Scientific
Inselspital
Urology Department (Urologische Universitätsklinik)
Bern
3010
Switzerland
Study information
| Study design | Prospective single centre double blind randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet [in German] |
| Scientific title | Clinical impact of early enteral versus parenteral nutrition following cystectomy evaluated in a prospective randomised trial |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/07/2010 |
| Completion date | 01/03/2012 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 198 |
| Key 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 |
| Key exclusion criteria | 1. Age <18y 2. Pregnancy 3. No informed consent available 4. Previous radiotherapy to the pelvis 5. Prior bowel surgery |
| Date of first enrolment | 01/07/2010 |
| Date of final enrolment | 01/03/2012 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Inselspital
Bern
3010
Switzerland
3010
Switzerland
Sponsor information
Inselspital, University Hospital Berne (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Urology Department (Urologische Universitätsklinik)
Bern
3010
Switzerland
"ROR" |
https://ror.org/01q9sj412 |
|---|
Funders
Funder type
Hospital/treatment centre
Inselspital, University Hospital Berne (Switzerland) - Urology Department (Urologische Universitätsklinik)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2013 | Yes | No |
