Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: 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
Sponsors
West bengal university of health sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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
| Measure | Time frame |
|---|---|
| Success rate of both procedures. Group A- Tissue glue Group B- Martius flapTimepoint: 3 weeks, 6 weeks & 12 weeks. | — |
Countries
India
Contacts
Public ContactDr. Sunirmal Choudhury
medical college kolkata
Outcome results
None listed