| CTRI Number |
CTRI/2024/11/076132 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Tissue glue] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Vesico-vaginal fistula (VVF) repair: Newer technique with tissue glue. |
|
Scientific Title of Study
|
Use of fibrin glue versus martius flap interpositioning in vesicovaginal fistula repair: A prospective randomized trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Sunirmal Choudhury |
| Designation |
Professor and head of department of urology, Medical college kolkata. |
| Affiliation |
medical college kolkata |
| Address |
DEPARTMENT OF UROLOGY, SUPERSPECIALITY BLOCK 7TH FLOOR, NEAR GATE NO. 5 , MEDICAL COLLEGE KOLKATA, COLLEGE STREET
Kolkata
WEST BENGAL
700073
India |
| Phone |
9433855577 |
| Fax |
|
| Email |
sunir09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sunirmal Choudhury |
| Designation |
Professor and head of department of urology, Medical college kolkata. |
| Affiliation |
medical college kolkata |
| Address |
DEPARTMENT OF UROLOGY, SUPERSPECIALITY BLOCK 7TH FLOOR, NEAR GATE NO. 5 , MEDICAL COLLEGE KOLKATA, COLLEGE STREET
Kolkata
WEST BENGAL
700073
India |
| Phone |
9433855577 |
| Fax |
|
| Email |
sunir09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sunirmal Choudhury |
| Designation |
Professor and head of department of urology, Medical college kolkata. |
| Affiliation |
medical college kolkata |
| Address |
DEPARTMENT OF UROLOGY, SUPERSPECIALITY BLOCK 7TH FLOOR, NEAR GATE NO. 5 , MEDICAL COLLEGE KOLKATA, COLLEGE STREET
Kolkata
WEST BENGAL
700073
India |
| Phone |
9433855577 |
| Fax |
|
| Email |
sunir09@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF UROLOGY, SUPERSPECIALITY BLOCK 7TH FLOOR, NEAR GATE NO. 5 , MEDICAL COLLEGE KOLKATA, COLLEGE STREET,Kolkata, West Bengal, India
Pincode: 700073 |
|
|
Primary Sponsor
|
| Name |
West bengal university of health sciences |
| Address |
GN-29 Sector-V, Salt Lake, Street Number 2, Kolkata, West Bengal 700091 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunirmal Choudhury |
Medical college kolkata |
Department of urology, Super-speciality block, near gate number 5, medical college kolkata, Kolkata, West Bengal.
pincode: 700073
Kolkata
WEST BENGAL |
9433855577
sunir09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ( REG. NO. - ECR/287/INST/WB/2013/RR-19) MEDICAL COLLEGE KOLKATA 88, COLLEGE STREET, KOLKATA 700073, WEST BENGAL, INDIA. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Martius flap |
Martius flap is extracted from lateral to labia majora with fibro-fatty tissue and vascular pedicle and secured to fistula with vicryl 2-0 suture. |
| Intervention |
Tissue glue (Tisseal) |
4 ml tissue glue made by reconstituting 1 ml of Sealer Protein (concentrate lyophilized human, vapour heated, sterile) and 1 ml of Aprotinin solution with 1 ml of Human thrombin lyophilized and 1 ml of Calcium chloride solution. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion criteria for this study were single VVF
smaller than 3 cm presented to us atleast 3 months later from her last
intervention without any other associated fistula, ureteric involvement or bladder
neck injury diagnosed clinically, and after IVU/CT Urography. |
|
| ExclusionCriteria |
| Details |
Previous history of
VVF surgery (vaginal), short vagina, positive urine culture, coagulopathies and
unwilling patients were all excluded from OUR STUDY.
The study excluded patients who on examination had more than one VVF, failed
repairs transvaginally, post-radiation therapy, or cancer related to VVF. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
I. To assess the safety of the procedure.
II. To assess the operative time and hospital stay.
III. To note the leak free rate i.e. effectiveness of the procedure.
IV. To evaluate the complications associated with the procedure. |
I. Safety assessed from application to 48 hours.
II. OPERATIVE TIME: From induction of anesthesia to reversal of anesthesia, Hospital stay is from OT day to discharge.
III. Leak free status is 3 weeks after OT followed by 3 months after OT.
IV. To assess complications 4 weeks is a time. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Success rate of both procedures.
Group A- Tissue glue
Group B- Martius flap |
3 weeks, 6 weeks & 12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To evaluate the outcome of fibrin glue and martius flaps as interpositioning layer in vesicovaginal fistula repair in terms of success rate, advantages and complications. Objectives: I. To assess the safety of the procedure. II. To assess the operative time and hospital stay. III. To note the leak free rate i.e. effectiveness of the procedure. IV. To evaluate the complications associated with the procedure.
All surgeries were performed by single surgeon in dorsal lithotomy position under spinal anaesthesia and epidural block for post-operative analgesia. We have used TISSEEL (Fibrin Sealant) for Surgical Care of Baxtor, which is supplied to its state hospitals by government. (West Bengal) Group A in which VVFs repair is anatomically using fibrin glue interpositioning and Group B in which VVFs will be treated using only Martius flap during anatomical surgical repair as an intervening layer between the bladder repair vaginal and repair. |