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Completed

NCT Number: NCT02050451

Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy

The current study is designed to assess the impact of an enriched oral nutritional shake (Ensure Plus®) to improve the nutritional status and patient outcome after surgery to remove a cancerous bladder (radical cystectomy). Radical cystectomy with urinary diversion using a segment of intestine is the standard of care for invasive bladder cancer. This operation has a high complication rate and several studies have shown that this may be directly related to poor nutrition.

The investigators believe that patients who consume an enriched nutritional shake before and after surgery will improve their nutrition status and experience fewer complications, shorter length of stay and less readmissions compared to those who do not.

Patients who are scheduled to undergo elective radical cystectomy will be eligible for enrollment. Once enrolled, they will be randomly assigned to one of two groups. One group will be offered Ensure Plus® twice daily for 2 weeks before and 4 weeks after their surgery and the other will be offered a daily over-the-counter multivitamin for the same period of time. The investigators will follow both groups for up to 30 days after their surgery and compare clinical outcomes such as: complication rates, length of stay, readmission rates and mortality as well as measure serum markers of nutrition status and assess changes in body composition.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients eligible for elective radical cystectomy for bladder cancer at the sponsoring institution

Exclusion criteria

  • inability to tolerate oral supplementation

Treatment and study plan

Ensure Plus®

Dietary Supplement

Other names: Ensure®

Multivitamin

Dietary Supplement

Primary outcomes

  1. Hospital-free days (HFDs)

    Time frame: 30 days

    The study is powered to detect a difference in the number of HFDs over a 30 day period between intervention and control groups

Secondary outcomes

  1. Serum markers

    Time frame: 30 days

    The investigators will compare serum levels of albumin, prealbumin, transferrin and retinol binding protein and C-reactive protein between groups

  2. Body composition

    Time frame: 30 days

    The investigators will measure difference in lean body mass and fat mass between intervention and controls using whole body dual energy X-ray absorptiometry (DEXA) scan

  3. Tolerability / compliance

    Time frame: 30 days

    The investigators will assess the patients' ability to tolerate and comply with the nutrition intervention

  4. Complications

    Time frame: 30 days

    The investigators will compare the difference in rate, type and severity of post-operative complications between groups

  5. Length of stay

    Time frame: 30 days

    The investigators will compare the length of stay following surgery between the two groups

  6. Readmission rate

    Time frame: 30 days

    The investigators will compare the rate of readmissions over the 30 day postoperative period between intervention and control

  7. Mortality

    Time frame: 30 days

    The investigators will compare overall survival between groups over the 30 day postoperative period

  8. Calories

    Time frame: 30 days

    The investigators will compare caloric and nutrient intake between groups using comprehensive dietary assessment tools

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • University of Oklahoma

Registry information

Official study title

A Pilot Study of Perioperative Oral Nutrition Supplementation to Improve Nutritional Status, Post-operative Complications, Length of Stay and Readmission Rates in Patients Undergoing Radical Cystectomy

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jan 30, 2014
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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