Radical Cystectomy, Nutrition and Convalescence

NCT ID: NCT02238886

Last Updated: 2014-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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The study is a randomized controlled trial. Inclusion criteria: Bladder cancer, ability to give an informed consent. Exclusion criteria: Previous radiation therapy at the pelvic area, ureterocutaneostomy or robot-assisted surgery. The intervention aims to secure that 75% of the patient's total energy and protein needs are met during hospitalization.

Primary outcome: Quality of Life, using the EORTC QLQ-C30 and BLM30 questionnaire. Secondary outcomes: Body-weight, Hand Grip strength, biochemical measures, length of hospital stay, time to bowel recovery. The follow-up period is 12 weeks. Statistical analysis is performed in collaboration with a statistician.

Conditions

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Urinary Bladder Neoplasms Cystectomy Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Parenteral nutrition

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

Group Type EXPERIMENTAL

Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi

Intervention Type DIETARY_SUPPLEMENT

Standard treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Bladder cancer
* Ability to give an informed consent

Exclusion Criteria

* Previous radiation therapy at the pelvic area
* Ureterocutaneostomy
* Robot-assisted surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Line Noes Lydom

Clinical nurse specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dep. of Urology. University Hospital Rigshospitalet, Copenhagen Denmark

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-2-2011-114

Identifier Type: -

Identifier Source: org_study_id

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