Oral Nutrition After Regular Radical Cystectomy

NCT01777126 | Completed Phase 4 Results

• 1 other identifier: ONP
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Cystostomy

Keywords

cystectomy; parenteral nutrition; discharge; outcome

Outcome Measures

Primary Outcomes (1)

• the Postoperative Length of Stay

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

  one month after surgery

Secondary Outcomes (8)

• Successful Implementation Rate of the ONP in the Experimental Group

  30 days postoperative

• Number of Administered PN

  30 days postoperative

• The Time to Resumption of Full Diet.

  30 days postoperative

• Patients With One or More Postoperative Complication.

  30 days postoperative

• The Number of Postoperative Complications Per Patient.

  30 days postoperative

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Oral Nutrition Protocol (ONP) group

EXPERIMENTAL

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

Interventions

Oral Nutrition Protocol (ONP) group OTHER

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.

Oral Nutrition Protocol (ONP) group

Control group OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• regular radical cystectomy

You may not qualify if:

• preoperative contra-indications for enteral nutrition (EN): intestinal obstruction, malabsorption, multiple high-output fistula and intestinal ischemia

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Hyperphagia

Interventions

Population Groups; Control Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Peter Declercq
• Organization: Pharmacy Department, University Hospitals Leuven & Department of Pharmaceutical and Pharmacological Sciences, KULeuven, Belgium

peter.declercq@uzleuven.be

003216342340

Study Officials

• Peter Declercq, Pharm.D

  Pharmacy Department, University Hospitals Leuven & Department of Pharmaceutical and Pharmacological Sciences, KULeuven, Belgium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 28, 2013
• Study Start: January 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: November 1, 2012
• Last Updated: July 17, 2014
• Results First Posted: July 17, 2014

Record last verified: 2011-01

Locations

BE (1)