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Oral Nutrition After Regular Radical Cystectomy (ONP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01777126
Recruitment Status : Completed
First Posted : January 28, 2013
Results First Posted : July 17, 2014
Last Update Posted : July 17, 2014
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Post Cystostomy
Interventions Other: Oral Nutrition Protocol (ONP) group
Other: Control group
Enrollment 94
Recruitment Details All adult patients admitted undergoing an elective and unproblematic radical cystectomystarting in 01/02/2009 were consecutively assigned to the control group until the predefined sample size was attained. After completion of the control group, all newly admitted patients were, again consecutively, assigned to the experimental group.
Pre-assignment Details If a transfer was needed, the patient was excluded. Other exclusion criteria were preoperative contra-indications for EN and discharge to a rehabilitation center.
Arm/Group Title Control Group Oral Nutrition Protocol (ONP) Group
Hide Arm/Group Description In the control group, PN was part of the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. In this group, oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
Period Title: Overall Study
Started 48 46
Completed 48 46
Not Completed 0 0
Arm/Group Title Control Group Oral Nutrition Protocol (ONP) Group Total
Hide Arm/Group Description Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group. Total of all reporting groups
Overall Number of Baseline Participants 48 46 94
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Age Number Analyzed 48 participants 46 participants 94 participants
66.0
(55 to 75)
65.5
(57 to 72.5)
66
(55.75 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 46 participants 94 participants
Female
17
  35.4%
12
  26.1%
29
  30.9%
Male
31
  64.6%
34
  73.9%
65
  69.1%
Length  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 48 participants 46 participants 94 participants
169.7  (8.2) 170.8  (8.0) 170.3  (8.1)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 48 participants 46 participants 94 participants
73.7  (13.9) 75.4  (14.2) 74.6  (14.1)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 48 participants 46 participants 94 participants
25.5  (4.0) 25.8  (4.3) 25.7  (4.1)
Age-adjusted Charlson Comorbidity Index   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Points
Number Analyzed 48 participants 46 participants 94 participants
4
(3 to 5)
5
(3 to 6)
4
(3 to 6)
[1]
Measure Description: The Age-adjusted Charlson Comorbidity index encompasses 19 medical conditions weighted 1–6 with total scores ranging from 0–37. Mortality for each disease was converted to a relative risk of death within 12 months and a weight was then assigned. From the weighted conditions, a sum score can be tallied to yield the total comorbidity score. The CCI can be further adapted to account for increasing age. To account for the effects of increasing age, one point can be added to the CCI score for each decade of life over the age of 50 [13].
Indication  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 48 participants 46 participants 94 participants
Neurogenic 9 6 15
Oncologic 39 40 79
Bladder staging   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 48 participants 46 participants 94 participants
T+N0M0 1 1 2
T+N+M0 1 0 1
T+N+M+ 38 40 78
T0N0M0 8 5 13
[1]
Measure Description:

The TNM system has been widely adopted in bladder staging. The number of Ts Ns and Ms depend on the tumour / site.

T: Tumour N: Node M: Metastases

Type of urinary diversion  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 48 participants 46 participants 94 participants
Ileal conduit 40 39 79
Orthothopic neobladder 6 7 13
Continent cutaneous diversion 2 0 2
Surgeon  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 48 participants 46 participants 94 participants
Surgeon 1. 5 0 5
Surgeon 2. 19 14 33
Surgeon 3. 5 3 8
Surgeon 4. 19 29 48
Blood loss   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Ml
Number Analyzed 48 participants 46 participants 94 participants
1000
(500 to 1475)
1000
(600 to 1650)
1000
(575 to 1500)
[1]
Measure Description: Volume of blood loss during surgery.
Duration of procedure  
Median (Inter-Quartile Range)
Unit of measure:  Minute
Number Analyzed 48 participants 46 participants 94 participants
210
(180 to 240)
187.5
(180 to 240)
210
(180 to 240)
Postoperative ileus   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 48 participants 46 participants 94 participants
POI 9 13 22
no POI 39 33 72
[1]
Measure Description: Postoperative ileus was defined as the inability to tolerate solid food, the need to place a nasogastric tube in suction or the need to stop oral intake due to abdominal distention, nausea or emesis.
Nasogastric tube removal day  
Median (Inter-Quartile Range)
Unit of measure:  Day
Number Analyzed 48 participants 46 participants 94 participants
2
(1 to 4.75)
2
(1 to 3)
2
(1 to 3)
1.Primary Outcome
Title the Postoperative Length of Stay
Hide Description The primary outcome measure was the interval from surgery to discharge. Discharge means that the patient returns to his home.
Time Frame one month after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Primary outcome measure was interval from surgery to discharge. Discharge means that the patient returns back to his home and not to a rehabilitation center.
Arm/Group Title Control Group Oral Nutrition Protocol (ONP) Group
Hide Arm/Group Description:
For subjects enrolled in this arm, PN was part of the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
Overall Number of Participants Analyzed 48 46
Median (Inter-Quartile Range)
Unit of Measure: day
18
(15 to 22)
14
(13 to 18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Oral Nutrition Protocol (ONP) Group
Comments The primary outcome measure was the interval from surgery to discharge. Discharge means that the patient returns to his home. Preliminary data from our institution showed that all patients received parenteral nutrition very early post-surgery and were discharged after a mean of 19.3 ± 5.6 days. Therefore, the primary objective by implementing the ONP was to reduce the length of stay with 3 days.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Successful Implementation Rate of the ONP in the Experimental Group
Hide Description Successful implementation of the ONP was achieved if the patient followed the protocol and did not need PN.
Time Frame 30 days postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
The number of patients with successful implementation of the ONP in the experimental group.
Arm/Group Title Oral Nutrition Protocol (ONP) Group
Hide Arm/Group Description:
Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: participants
40
3.Secondary Outcome
Title Number of Administered PN
Hide Description Number of administered PN per group
Time Frame 30 days postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Oral Nutrition Protocol (ONP) Group
Hide Arm/Group Description:
Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
Overall Number of Participants Analyzed 48 46
Measure Type: Number
Unit of Measure: number of PN
435 24
4.Secondary Outcome
Title The Time to Resumption of Full Diet.
Hide Description The time to resumption of full diet between the two groups was compared.
Time Frame 30 days postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Oral Nutrition Protocol (ONP) Group
Hide Arm/Group Description:
Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
Overall Number of Participants Analyzed 48 46
Median (Inter-Quartile Range)
Unit of Measure: day
8
(6 to 9)
4
(3 to 5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Oral Nutrition Protocol (ONP) Group
Comments Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using the Wilcoxon rank sum test. The result was considered statistically significant if p-values were < 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 4
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Patients With One or More Postoperative Complication.
Hide Description Number of patients with one or more postoperative complication were compared betweent the two groups.
Time Frame 30 days postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Oral Nutrition Protocol (ONP) Group
Hide Arm/Group Description:
Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
Overall Number of Participants Analyzed 48 46
Measure Type: Number
Unit of Measure: participants
37 32
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Oral Nutrition Protocol (ONP) Group
Comments Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square and Fisher’s Exact Test. Results were considered statistically significant if p-values were < 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.487
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title The Number of Postoperative Complications Per Patient.
Hide Description The number of postoperative complications per patient was compared between the two groups.
Time Frame 30 days postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Oral Nutrition Protocol (ONP) Group
Hide Arm/Group Description:
Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
Overall Number of Participants Analyzed 48 46
Median (Inter-Quartile Range)
Unit of Measure: number of postoperative complications
1
(1 to 2)
1
(0 to 2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Oral Nutrition Protocol (ONP) Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.302
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Patients With a Catheter Related Bloodstream Infection
Hide Description Patients with a catheter related bloodstream infection were compared between the two groups
Time Frame 30 days postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Oral Nutrition Protocol (ONP) Group
Hide Arm/Group Description:
Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
Overall Number of Participants Analyzed 48 46
Measure Type: Number
Unit of Measure: participants
4 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Oral Nutrition Protocol (ONP) Group
Comments Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Fisher’s Exact Test. The result was considered statistically significant if p-values were < 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.117
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title The Type of Postoperative Complications.
Hide Description 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.
Time Frame 30 days postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Oral Nutrition Protocol (ONP) Group
Hide Arm/Group Description:
Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
Overall Number of Participants Analyzed 48 46
Measure Type: Number
Unit of Measure: number per type of POC
1. Infection 21 13
2. Fistula or leak 1 2
3. Bleeding or hematoma 5 2
4. Gastro-intestinal 13 16
5. Cardiopulmonary 13 4
6. Neurologic 0 5
7. Pain 2 0
8. Other 15 11
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Oral Nutrition Protocol (ONP) Group
Comments Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square Test. Outcome measures were considered statistically significant if p-values were < 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
9.Secondary Outcome
Title Severity Grade of Postoperative Complications.
Hide Description 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.
Time Frame 30 days postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Oral Nutrition Protocol (ONP) Group
Hide Arm/Group Description:
Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
Overall Number of Participants Analyzed 48 46
Measure Type: Number
Unit of Measure: number of POCs per severity grade
Severity Grade 1 Clavien Dindo 15 16
Severity Grade 2 Clavin Dindo 35 23
Severity Grade 3a Clavien Dindo 16 12
Severtity Grade 3b Clavine Dindo 4 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Oral Nutrition Protocol (ONP) Group
Comments Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square Test. Outcome measures were considered statistically significant if p-values were < 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.698
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame 30 days
Adverse Event Reporting Description

Number of patients with one or more postoperative complications (POC), number of POCs per patient and type and severity grade of POCs.

The type and severity of POCs were classified using the Clavien-Dindo classification16. POCs were classified into 11 categories and stratified by severity.

 
Arm/Group Title Control Group Enhanced Recovery Oral Nutrition Protocol (ERONP) Group
Hide Arm/Group Description 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. Subjects enrolled in this arm will undergo the ERONP protocol. 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.
All-Cause Mortality
Control Group Enhanced Recovery Oral Nutrition Protocol (ERONP) Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Control Group Enhanced Recovery Oral Nutrition Protocol (ERONP) Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/48 (0.00%)      0/46 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group Enhanced Recovery Oral Nutrition Protocol (ERONP) Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/48 (77.08%)      32/46 (69.57%)    
Cardiac disorders     
Cardiopulmonary  1  11/48 (22.92%)  12 4/46 (8.70%)  4
Gastrointestinal disorders     
DGE/Nausea&vomiting  1  10/48 (20.83%)  13 15/46 (32.61%)  16
General disorders     
Fistula or leak  1  1/48 (2.08%)  1 2/46 (4.35%)  2
Bleeding  1  5/48 (10.42%)  5 2/46 (4.35%)  2
Pain  1  2/48 (4.17%)  2 0/46 (0.00%)  0
Other  1  13/48 (27.08%)  15 11/46 (23.91%)  11
Infections and infestations     
Infection  1  20/48 (41.67%)  21 13/46 (28.26%)  13
Nervous system disorders     
Neurologic  1  0/48 (0.00%)  0 3/46 (6.52%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, Clavien Dindo
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter Declercq
Organization: Pharmacy Department, University Hospitals Leuven & Department of Pharmaceutical and Pharmacological Sciences, KULeuven, Belgium
Phone: 003216342340
EMail: peter.declercq@uzleuven.be
Layout table for additonal information
Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01777126    
Other Study ID Numbers: ONP
First Submitted: January 15, 2013
First Posted: January 28, 2013
Results First Submitted: February 7, 2013
Results First Posted: July 17, 2014
Last Update Posted: July 17, 2014