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Oral Nutrition After Regular Radical Cystectomy (ONP)

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: July 16, 2014
Last verified: January 2011
  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.

A non-randomized before-after trial was conducted. Patients treated with an elective regular radical cystectomy and without preoperative contra-indications for enteral nutrition were eligible. In the control group, PN was initiated immediately after the procedure and continued until resumption of diet. In the interventional group, an ONP was implemented. PN could be initiated if oral intake was still insufficient after five days. The primary end point was the postoperative length of stay.


Condition Intervention Phase
Post Cystostomy
Other: Oral Nutrition Protocol (ONP) group
Other: Control group
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Simple Oral Nutrition Protocol Reduces Length of Stay in Patients With Regular Radical Cystectomy

Resource links provided by NLM:


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 ]
    The primary outcome measure was the interval from surgery to discharge. Discharge means that the patient returns to his home.


Secondary Outcome Measures:
  • Successful Implementation Rate of the ONP in the Experimental Group [ Time Frame: 30 days postoperative ] [ Designated as safety issue: No ]
    Successful implementation of the ONP was achieved if the patient followed the protocol and did not need PN.

  • Number of Administered PN [ Time Frame: 30 days postoperative ] [ Designated as safety issue: No ]
    Number of administered PN per group

  • The Time to Resumption of Full Diet. [ Time Frame: 30 days postoperative ] [ Designated as safety issue: No ]
    The time to resumption of full diet between the two groups was compared.

  • Patients With One or More Postoperative Complication. [ Time Frame: 30 days postoperative ] [ Designated as safety issue: No ]
    Number of patients with one or more postoperative complication were compared betweent the two groups.

  • The Number of Postoperative Complications Per Patient. [ Time Frame: 30 days postoperative ] [ Designated as safety issue: No ]
    The number of postoperative complications per patient was compared between the two groups.

  • Patients With a Catheter Related Bloodstream Infection [ Time Frame: 30 days postoperative ] [ Designated as safety issue: No ]
    Patients with a catheter related bloodstream infection were compared between the two groups

  • The Type of Postoperative Complications. [ Time Frame: 30 days postoperative ] [ Designated as safety issue: No ]
    The type of postoperative complications (POCs) were compared between the two groups. The type of POCs were classified using the Clavien-Dindo Classification. Herein POCs were classified into 8 categories (1. Infection, 2. Fistula/leak, 3. Bleeding/hematoma, 4. Gastrointestinal, 5. Cardiopulmonary, 6. Neurologic, 7. pain and 8. Other) and stratified by their severity grade (Table 2). Per patient, multiple complications are possible.

  • Severity Grade of Postoperative Complications. [ Time Frame: 30 days postoperative ] [ Designated as safety issue: No ]
    Severity grade of postoperative complications (POCs) was compared between the two groups. The severity grade of POCs were classified using the Clavien-Dindo Classification. Per patient, multiple complications are possible.


Enrollment: 94
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: Oral Nutrition Protocol (ONP) group
Oral intake was increased progressively with oral fluids and easily digestible food, independent of bowel movements. The corresponding energy content from the meals and oral fluids were calculated. Fortimel Jucy®, 200 ml containing 300 kcal, was used as the formulary energy sip. Extra fluids, up to two liter per day, were given intravenously, at the discretion of the treating physician. If the patient tolerated the ONP well, the oral intake was considered equal in terms of calories as the corresponding oral meal in the ONP. From the sixth day, the patient was allowed to eat at will. Only if oral intake remained insufficient after 5 days, which was left to the opinion of the treating physician, PN could be initiated in this group.
Other: Oral Nutrition Protocol (ONP) group
For the experimental group, an oral nutrition protocol (ONP) 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 Jucy® (Nutricia) 200 ml containing 300 kcal. This provides supplementary energy and essential nutrients. Supplementary fluid, approximately up to two liter, is given intravenously. Only if oral intake is still insufficient after five days, PN (Oliclinomel N7) can be initiated.

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • regular radical cystectomy

Exclusion Criteria:

  • preoperative contra-indications for enteral nutrition (EN): intestinal obstruction, malabsorption, multiple high-output fistula and intestinal ischemia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Peter Declercq, Pharm.D Pharmacy Department, University Hospitals Leuven & Department of Pharmaceutical and Pharmacological Sciences, KULeuven, Belgium
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01777126     History of Changes
Other Study ID Numbers: ONP
Study First Received: January 15, 2013
Results First Received: February 7, 2013
Last Updated: July 16, 2014
Health Authority: Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on November 24, 2014