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Implementation of an Enhanced Recovery Oral Nutrition Protocol After Unproblematic Radical Cystectomy Reduces Interval to Discharge. (ERONP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01777126
First received: January 15, 2013
Last updated: January 23, 2013
Last verified: January 2011
History of Changes
  Purpose

After radical cystectomy, postoperative ileus (POI) is a common complication resulting in a delayed oral nutritional intake with prolonged recovery and hospital stay. However, it is questionable if nutritional support by routine use of parenteral nutrition (PN) is justifiable or cost-effective.

This study includes patients undergoing elective unproblematic radical cystectomy in a single institution. In the control group there are no parenteral nutrition (PN) restrictions. In the experimental group, an Enhanced Recovery Oral Nutrition Protocol (ERONP) will be introduced and PN can be initiated if oral intake is still insufficient after five days. Outcome measure are postoperative length of stay.


Condition Intervention Phase
Radical Cystecomy
 Other: Enhanced Recovery Oral Nutrition Protocol (ERONP) group
Other: Control group
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Official Title: Implementation of an Enhanced Recovery Oral Nutrition Protocol After Unproblematic Radical Cystectomy Reduces Interval to Discharge.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • the postoperative length of stay [ Time Frame: one month after surgery ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: January 2009
Study Completion Date: November 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control group
Subjects enrolled in this arm will undergo usual medical and pharmaceutical care. In this group, parenteral nutrition (Oliclinomel N7) is part of the routine postoperative care program.
 Other: Control group
Subjects enrolled in this arm will undergo usual medical and pharmaceutical care. In this group, parenteral nutrition (Oliclinomel N7) is part of the routine postoperative care program.
Experimental: Enhanced Recovery Oral Nutrition Protocol (ERONP) group
Subjects enrolled in this arm will undergo the ERONP protocol.
 Other: Enhanced Recovery Oral Nutrition Protocol (ERONP) group
For the experimental group, an enhanced oral nutrition protocol (ERONP) with restrictive instructions for parenteral nutrition is implemented. Oral intake is increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used are Fortimel Juicy® (Nutricia) 200 ml containing 300 kcal. This provides supplementary energy and essential nutrients. Supplementary fluid, approximately up to two liter, is given intravenously. If the patient is unable to produce stools on the third day post-surgery, neostigmine (Prostigmin® 0.5 mg subcutaneous, maximum 4 times a day), an acetylcholinesterase inhibitor promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel, can be administered. Only if oral intake is still insufficient after five days, PN (Oliclinomel N7) can be initiated.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unproblematic radical cystectomy

Exclusion Criteria:

  • preoperative contra-indications for enteral nutrition (EN): intestinal obstruction, malabsorption, multiple high-output fistula and intestinal ischemia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777126

Locations
Belgium
University Hospitals Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01777126     History of Changes
Other Study ID Numbers: ERONP
Study First Received: January 15, 2013
Last Updated: January 23, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
cystectomy
parenteral nutrition
discharge
outcome

ClinicalTrials.gov processed this record on May 21, 2013