NCT02238886

Brief Summary

The purpose of this study is to determine whether a goal directed nutritional intervention can reduce the convalescence period for patients undergoing radical cystectomy (RC). The aim is to examine the effect on quality of life of a standard nutritional strategy of resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery versus a goal-directed nutritional intervention combining oral intake and parenteral nutrition, in patients undergoing RC.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

1.6 years

First QC Date

September 5, 2014

Last Update Submit

September 10, 2014

Conditions

Urinary Bladder NeoplasmsCystectomyBladder Cancer

Keywords

Quality of LifeEnteral nutritionNutrition TherapyParenteral nutrition, total

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life (HRQoL) using the EORTC QLQ-C30 and BLM30 (one combined questionnaire)

    Change from baseline HRQoL at 6 and 12 weeks following surgery

    meassured pre-operatively + 6 and 12 weeks following surgery

Secondary Outcomes (4)

  • Body weight

    preoperatively, 6 and 12 weeks postop

  • hand grip strength

    pre-operatively, 6 days and 6 weeks postop

  • length of hospital stay

    12 week follow-up

  • Time to bowel recovery

    12 week follow-up

Study Arms (2)

Parenteral nutrition

EXPERIMENTAL

Patients receives a goal-directed nutritional intervention combining oral intake and parenteral nutrition

Dietary Supplement: Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi

Standard treatment

NO INTERVENTION

patients receives a standard nutritional strategy of resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery

Interventions

Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius KabiDIETARY_SUPPLEMENT
Parenteral nutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bladder cancer
  • Ability to give an informed consent

You may not qualify if:

  • Previous radiation therapy at the pelvic area
  • Ureterocutaneostomy
  • Robot-assisted surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Urology. University Hospital Rigshospitalet, Copenhagen Denmark

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsHyperphagia

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical nurse specialist

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 12, 2014

Study Start

May 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations

DK(1)