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Completed

NCT Number: NCT02238886

Radical Cystectomy, Nutrition and Convalescence

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.

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Key information

Conditions

Urinary Bladder Neoplasms Bladder Cancer Cystectomy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperphagia Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Urinary Bladder Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dep. of Urology. University Hospital Rigshospitalet, Copenhagen Denmark

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Bladder cancer
  • Ability to give an informed consent

Exclusion criteria

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

Treatment and study plan

Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi

Dietary Supplement

Primary outcomes

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

    Time frame: meassured pre-operatively + 6 and 12 weeks following surgery

    Change from baseline HRQoL at 6 and 12 weeks following surgery

Secondary outcomes

  1. Body weight

    Time frame: preoperatively, 6 and 12 weeks postop

    Change from baseline weight at 6 and 12 weeks following the date of surgery

  2. hand grip strength

    Time frame: pre-operatively, 6 days and 6 weeks postop

    Change from baseline hand grip strength at 6 days and 6 weeks following the date of surgery

  3. length of hospital stay

    Time frame: 12 week follow-up

  4. Time to bowel recovery

    Time frame: 12 week follow-up

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

RADICAL CYSTECTOMY, NUTRITION AND CONVALESCENCE: CAN GOAL-DIRECTED POSTOPERATIVE NUTRITIONAL THERAPY REDUCE THE CONVALESCENCE PERIOD FOR PATIENTS UNDERGOING RADICAL CYSTECTOMY (RC)?

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 12, 2014
Registry last updated
Sep 12, 2014

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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