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Clinical impact of early enteral versus parenteral nutrition following cystectomy and extended pelvic lymphadenectomy

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79535150
Enrollment
198
Registered
2010-07-07
Start date
2010-07-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer / invasive disease / Urology Cancer Malignant neoplasm of bladder

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 substitut

Sponsors

Inselspital, University Hospital Berne (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Occurrence of postoperative complications according to the Dindo-Clavien classification with particular respect for infections. Measured within the first 30 days after surgery

Secondary

MeasureTime frame
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.

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026