Phase 4
N=94
Oral Nutrition After Regular Radical Cystectomy
Post Cystostomy
Bottom Line
View on ClinicalTrials.gov: NCT01777126 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: the Postoperative Length of Stay — 18; 14 day — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oral Nutrition Protocol (ONP) group (Other); Control group (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Postoperative Length of Stay |
18; 14 | <0.001 sig |
| SECONDARY Successful Implementation Rate of the ONP in the Experimental Group |
40 | — |
| SECONDARY Number of Administered PN |
435; 24 | — |
| SECONDARY The Time to Resumption of Full Diet. |
8; 4 | <0.01 sig |
| SECONDARY Patients With One or More Postoperative Complication. |
37; 32 | 0.487 |
| SECONDARY The Number of Postoperative Complications Per Patient. |
1; 1 | 0.302 |
| SECONDARY Patients With a Catheter Related Bloodstream Infection |
4; 0 | 0.117 |
| SECONDARY The Type of Postoperative Complications. |
21; 13; 1; 2; 5; 2 | 0.049 sig |
| SECONDARY Severity Grade of Postoperative Complications. |
15; 16; 35; 23; 16; 12 | 0.698 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01777126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.