Trial no.:	PACTR201301000446118	Date of Approval:	29/10/2012
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Ureteral stenting in orthotopic bladder substitutes

Official scientific title

Perioperative stenting with external ureteral catheters versus internal double J stents in orthotopic bladder substitutes: a prospective randomized trial

Brief summary describing the background and objectives of the trial

Necessity of routine ureteral stenting following urinary diversion is universally accepted and a recent randomized trial provided an evidence that ureteroileal anastomosis stenting allows for significantly less frequent incidence of early postoperative dilatation of the pelvicaliceal system with significantly earlier return of bowel activity and significantly less frequent metabolic acidosis . The ureteral double pigtail stents are versatile and valued for proper urinary drainage in the setting of trauma, fistula formation, after extra-corporeal shock wave lithotripsy. Two decades ago, Walther et al., did not recommend the use of internal stenting in this setting as it might induce lethal sepsis and death and suggested urologists to await further evolution in stent technology . Recently, two non randomized trials had provided the evidence that use of internal double J stents could be utilized safely in urinary diversion patients with significant reduction of hospital stay with earlier mobilization and minimal discomfort and without increase in ureteral stricture rates. We aimed to compare two group of patients with orthotopic ileal bladder substitution adopting two different types of uretero-ileal stenting ; external ureteroileal stents versus internal double J stents in a prospective controlled randomized trial

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

bladder cancer,Cancer,Surgery,Urological and Genital Diseases

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Surgery

Anticipated trial start date

01/09/2008

Actual trial start date

15/09/2008

Anticipated date of last follow up

03/10/2012

Actual Last follow-up date

03/10/2012

Anticipated target sample size (number of participants)

100

Actual target sample size (number of participants)

100

Recruitment status

Recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register
none	Urology and Nephrology Center

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	blind envelop method	the envelops are held with the head nurse of OR	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	internal dj stent	inapplicable	40 days	fixation of internal DJ stent after construction of an orthotopic pouch	50
Control Group	external ureteral stents	inapplicable	10 days	fixation of an external ureteral stent after construction of an orthotopic pouch	50

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Orthotopic substitution negative ureteral safety margin	incontinent urinary diversion Short ureters Technical difficulties		40 Year(s)	75 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

01/07/2008

UNC Ethics Comittee

Ethics Committee Address
Street address	City	Postal code	Country
70th Gomhoria St.	Mansoura	35516	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	1- Early perioperative complications (including urinary tract infections and urinary leakage) and mortality.	2 months
Primary Outcome	hospital stay	2 months
Secondary Outcome	ureteral stricture	1 year
Secondary Outcome	re-admission rate	1 year

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Urology & Nephrology Center	70th Gomhoria St.	Mansoura	35516	Egypt
Mansoura Urology Center		Gomhoria St.	35516	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
UNC	70th Gomhoria St.	Mansoura	35516	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Mansoura Urology and Nephrology Center	70th Gomhoria St.	Mansoura	35516	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country
Yasser Osman MD	70th Gomhoria St.	Mansoura	35516	Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Yasser Osman	y_osman99@yahoo.com	0020502262222	70th Gomhoria St.
City	Postal code	Country	Position/Affiliation
Mansoura	35516	Egypt	Associate professor
Role	Name	Email	Phone	Street address
Public Enquiries	Tamer Barakat	drtamerbarakat@gmail.com	0020502262222	70th Gomhoria St.
City	Postal code	Country	Position/Affiliation
Mansoura	35516	Egypt	Fellow in Urology
Role	Name	Email	Phone	Street address
Scientific Enquiries	Yasser Osman	y_osman99@yahoo.com	0020502262222	70th Gomhoria St.
City	Postal code	Country	Position/Affiliation
Mansoura	35516	Egypt	Associate professor

REPORTING
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URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date

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Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

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