The aim of this study is to evaluate the success of endoscopic transurethral repair of vesicovaginal fistula following hysterectomy.
Design
This study is a clinical trial with an intervention group in which 10 patients in the intervention group undergo surgery.
Settings and conduct
This study is performed in Al-Zahra and Khorshid hospitals. Patients are placed in the lithotomy position. First, a cystoscopy is performed, and the location and size of the fistula and the distance of the fistula from the bladder neck are examined and recorded. The urethra is then dilated to 30 French, and the implant sheet is shortened to 30 French. Vicryl 2-0 thread, the end of which is tied in a loop, enters the bladder through an amplitude sheet. In the next step, the nephroscope enters the bladder through an amplitude sheet. The fistula is repaired using a 3 mm endoscopic needle. For repair with a distance of 5 mm from the edges of the fistula with a depth of 3 mm from the mucosa of the sutures is applied continuously. The first knot is made by passing the needle through the created loop. For the last knot, two ends of the thread are tied outside the bladder, and the knot is brought to the place of repair inside the bladder.
Participants/Inclusion and exclusion criteria
In this study, patients are selected from all women who have vesicovaginal fistula after hysterectomy. Patients with passing more than a month of the onset of incontinence, fistula diameter more than 2 cm, multiple fistulas, vesicovaginal fistula recurrence history, radiation history, concomitant existence, and ureterovaginal or urethrovaginal fistula are excluded.
Intervention groups
In the intervention group, patients' vesicovaginal fissures are repaired by an endoscopic transurethral method.
Main outcome variables
operation time; success rate; readmission
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150420021869N3
Registration date:2021-07-18, 1400/04/27
Registration timing:prospective
Last update:2021-07-18, 1400/04/27
Update count:0
Registration date
2021-07-18, 1400/04/27
Registrant information
Name
Farshad Gholipour
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6636 2089
Email address
f-gholipour@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the success of endoscopic repair of transurethral vesicovaginal fistula after hysterectomy
Public title
Endoscopic repair of transurethral vesicovaginal fistula
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with vesicovaginal fistula after hysterectomy
Exclusion criteria:
Passing more than a month of the onset of incontinence
Fistula diameter more than 2 cm
Multiple fistulas
Vesicovaginal fistula recurrence history
Radiation history
Existence of concomitant ureterovaginal or urethrovaginal fistula
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan university of medical sciences, hezar jarib St, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.MUI.MED.REC.1400.231
Health conditions studied
1
Description of health condition studied
vesicovaginal fistula
ICD-10 code
N82.0
ICD-10 code description
Vesicovaginal fistula
Primary outcomes
1
Description
success rate
Timepoint
7 and 21 days after surgery
Method of measurement
history and physical examinaion
2
Description
operation time
Timepoint
At the start and end of operation
Method of measurement
hour
3
Description
readmission
Timepoint
until 21 days after sugery
Method of measurement
history
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients undergo endoscopic transurethral repair of vesicovaginal fistula.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Farshad Gholipour
Street address
Sofeh St
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
gholipour@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
khorshid hospital
Full name of responsible person
Farshad Gholiour
Street address
Ostandari St
City
Isfahan
Province
Isfehan
Postal code
8134659691
Phone
+98 31 3222 2127
Email
gholipour@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezar jarib St
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
gholipour@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farshad Gholipour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
No. 12, Mardavij St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8134659691
Phone
+98 31 3220 5826
Email
gholipour@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farshad Gholipour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
No. 12, Mardavij St., Isfahan, Iran
City
Isfaha
Province
Isfehan
Postal code
8134659691
Phone
+98 31 3220 5826
Email
gholipour@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farshad Gholipour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
No. 12, Mardavij St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8134659691
Phone
+98 31 3220 5826
Email
gholipour@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
There is no more information
When the data will become available and for how long
There is no more information
To whom data/document is available
There is no more information
Under which criteria data/document could be used
There is no more information
From where data/document is obtainable
There is no more information
What processes are involved for a request to access data/document