Use of fibrin glue versus martius flap interpositioning in vesicovaginal fistula repair: A prospective randomized trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- I. To assess the safety of the procedure.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
I. To assess the safety of the procedure.
时间窗: 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.
II. To assess the operative time and hospital stay.
时间窗: 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.
III. To note the leak free rate i.e. effectiveness of the procedure.
时间窗: 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.
IV. To evaluate the complications associated with the procedure.
时间窗: 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.
次要结局
- Success rate of both procedures.(Group A- Tissue glue)
研究者
Dr. Sunirmal Choudhury
medical college kolkata