Back to resultsOutcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy
Primary Purpose
Cancer, Bladder, Cystostomy; Complications
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Neo-mune powder (otsuka pharmaceutical)
Dipeptiven solution (Fresenius Kabi pharmaceutical)
Sponsored by
About this trial
This is an interventional prevention trial for Cancer, Bladder focused on measuring radical cystectomy, complications, immune-nutrition, immune enhancing nutrition, bladder cancer, muscle invasive bladder cancer
Eligibility Criteria
Inclusion Criteria: Patients with CT showing bladder mass with radiological staging of T2 or T3. Patients pathologically proven to have cancer bladder. Patients undergoing radical cystectomy with ileal conduit. The American Society of Anesthesiologists Physical Status classification system (ASA PS) of 1, 2 or 3. Exclusion Criteria: Coagulopathy. Distant metastasis. Body mass index less than 18.5. Relevant food allergies. Severe renal and hepatic insufficiency.
Sites / Locations
- Menoufia Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
conventional protocol group
immune enhancing nutrition protocol group
Arm Description
patients who are enrolled in conventional pre and post operative routine preparation for surgery protocol.
patients who are enrolled in immune enhancing nutrition protocol pre and post operatively.
Outcomes
Primary Outcome Measures
Postoperative complications
postoperative complications will be assessed and classified according to modified Clavien-Dindo classification. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V) in which grade I represents the least severe complications and grade V represents the most severe complications.
Wound healing
wound healing will be assessed by Pressure Ulcer Scale for Healing (PUSH) tool. this tool give every wound a score depending on surface area, exudate amount and tissue type. the scoring system ranging from 0 to 17 in which "0" represents completely healed wound and "17" represents the least healed wound. Surgical wounds are acute wounds that closure expected timeframe is about 4 weeks.
Secondary Outcome Measures
Length of hospital stay
will be measured by number of days to return to daily activity.
Infection rates
infection rate will be assessed by need for intervention or prescription of non-prophylactic antibiotics or presence of systemic inflammatory response syndrome (SIRS).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05822518
Brief Title
Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy
Official Title
Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the outcome of perioperative immune-nutrition with glutamine, arginine and fish oil in patients undergoing radical cystectomy as regards to enhancement of healing, increasing immunity and improving overall health status.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Bladder, Cystostomy; Complications
Keywords
radical cystectomy, complications, immune-nutrition, immune enhancing nutrition, bladder cancer, muscle invasive bladder cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional protocol group
Arm Type
No Intervention
Arm Description
patients who are enrolled in conventional pre and post operative routine preparation for surgery protocol.
Arm Title
immune enhancing nutrition protocol group
Arm Type
Active Comparator
Arm Description
patients who are enrolled in immune enhancing nutrition protocol pre and post operatively.
Intervention Type
Dietary Supplement
Intervention Name(s)
Neo-mune powder (otsuka pharmaceutical)
Intervention Description
Preoperative: Neo-mune (otsuka pharmaceutical) powder 60 gm o.d. orally (contains glutamine, arginine and fish oil) for 3 days.
Postoperative: Neo-mune (otsuka pharmaceutical) powder 60 gm o.d. orally (contains glutamine, arginine and fish oil) for 2 weeks starting when the intestinal sounds are audible.
Intervention Type
Drug
Intervention Name(s)
Dipeptiven solution (Fresenius Kabi pharmaceutical)
Intervention Description
Dipeptiven (Fresenius Kabi pharmaceutical) solution 50 mg o.d IV ( contains L-ananyl-L-glutamine dipeptide) post operatively for 2 weeks starting from the operation day.
Primary Outcome Measure Information:
Title
Postoperative complications
Description
postoperative complications will be assessed and classified according to modified Clavien-Dindo classification. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V) in which grade I represents the least severe complications and grade V represents the most severe complications.
Time Frame
30 days
Title
Wound healing
Description
wound healing will be assessed by Pressure Ulcer Scale for Healing (PUSH) tool. this tool give every wound a score depending on surface area, exudate amount and tissue type. the scoring system ranging from 0 to 17 in which "0" represents completely healed wound and "17" represents the least healed wound. Surgical wounds are acute wounds that closure expected timeframe is about 4 weeks.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
will be measured by number of days to return to daily activity.
Time Frame
30 days
Title
Infection rates
Description
infection rate will be assessed by need for intervention or prescription of non-prophylactic antibiotics or presence of systemic inflammatory response syndrome (SIRS).
Time Frame
30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with CT showing bladder mass with radiological staging of T2 or T3.
Patients pathologically proven to have cancer bladder.
Patients undergoing radical cystectomy with ileal conduit.
The American Society of Anesthesiologists Physical Status classification system (ASA PS) of 1, 2 or 3.
Exclusion Criteria:
Coagulopathy.
Distant metastasis.
Body mass index less than 18.5.
Relevant food allergies.
Severe renal and hepatic insufficiency.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ammar F AlOrabi
Phone
+201067608011
Email
Ammar.Alorabi95@gmail.com
Facility Information:
Facility Name
Menoufia Faculty of Medicine
City
Shibin Al Kawm
State/Province
Menoufia
ZIP/Postal Code
13829
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed A Selim
Phone
+201066812765
Email
Abdelgaber_m@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy
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