Use of only one catheter & eliminate cystostomy and internalized ureteral catheter after radical cystectomy & orthotopic neobladder formation with syncoronize use of sandostatin
The objective of this study is to evaluate long acting Sandostain effects on reducing mucus after radical cystectomy surgery and neobladder formation with using only one urethral catheter and removal of suprapubic catheter (that used in usual surgical technique) and internalizing ureter catheters. A total of twenty patients with muscle invasive bladder cancer without urethral involvement will undergo radical cystectomy and neobladder formation. Instead of the usual operation, we eliminate suprapubic catheter in these people and internalize ureter catheters and randomly allocate into the following groups. For patients in one group, long acing Sandostatin is injected, deeply intramuscularly, two weeks before at the day of surgery. The patients in another group won’t receive any drug. The mucus volume, incidence and the number of bladder washings during hospitalization will be compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101025527N1
Registration date:2011-02-03, 1389/11/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-02-03, 1389/11/14
Registrant information
Name
Hamidreza Zia
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 311625555
Email address
hamidzia@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2009-11-22, 1388/09/01
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Use of only one catheter & eliminate cystostomy and internalized ureteral catheter after radical cystectomy & orthotopic neobladder formation with syncoronize use of sandostatin
Public title
Sandostatin uses in orthotopic ileal neobladder
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: invasive bladder carcinoma, no urethral involvement, patient consent to perform surgery in this manner
Exclusion criteria: urethral involvement in frozen section
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Science, hezar jirib street
City
Isfahan
Postal code
Approval date
2009-11-09, 1388/08/18
Ethics committee reference number
187140
Health conditions studied
1
Description of health condition studied
bladder cancer
ICD-10 code
C67
ICD-10 code description
Malignant neoplasm of bladder
Primary outcomes
1
Description
24-hour urine Mucous volume
Timepoint
on days seven and twenty one after surgery
Method of measurement
24-hour urine was collected and its mucus volume in gram was recorded
Secondary outcomes
1
Description
The number of washings
Timepoint
every 2 hours
Method of measurement
if urine flow become slow or urethral catheter blockage bladder irrigation is done & number of washings was recorded
2
Description
Average time for drying of dressing
Timepoint
daily visit
Method of measurement
with daily visit and scale day from surgery
Intervention groups
1
Description
Intervention group: two doses (20 mg every doses and total 40 mg) deep intramuscular long acting Sandostatin two weeks before surgery and just before surgery. After cystectomy, a specimen from proximal part of urethral is taken and sent for Frozen section and if the specimen will negative, neobladder will created with 40 cm of ileum, internalized ureters catheters and use just only urethral Foley catheter. Routine neobladder washing was not done unless there was a slow urine flow or a urethral catheter blockage.
Category
Treatment - Drugs
2
Description
Control group: after cystectomy, a specimen from proximal part of urethral is taken and sent for Frozen section and if the specimen will negative, neobladder will created with 40 cm of ileum, internalized ureters catheters and use just only urethral Foley catheter. Routine neobladder washing was not done unless there was a slow urine flow or a urethral catheter blockage.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellery of Research of Isfahan University of Medical Sciences
Full name of responsible person
Zahra Fallah
Street address
Bulding NO 4, Isfahan University of Medical Sciences, Hezar jerib street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery of Research of Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Hamidreza Zia
Position
Resident of urology
Other areas of specialty/work
Street address
Alzahra hospital, shohadae sofe street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
hzyia@yahoo.com . hamidzia@residen.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohammad Hatef Khorrami
Position
MD, urologist
Other areas of specialty/work
Street address
Alzahra hospital, Shohadae sofe street, Isfahan
City
Ifahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
khorami@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Hamidreza Zia
Position
Resident of urology
Other areas of specialty/work
Street address
Alzahra hospital, shohadae sofe street, isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
hzyia@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)