Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery Part 1-Cystoinflation in Repeat C-section Part 2- Cystoinflation in Abdominal Hysterectomy Part3- Cystoinflation in Placenta Accreta Spectrum Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 564
- 试验地点
- 1
- 主要终点
- Bladder Injury Rate
研究概览
简要总结
Part1:The healthy pregnant women with previous operative deliveries admitted for elective C-section will be counselled and conditioned informed consent will be taken to be included in either study group if dense pelvic adhesions will be found during their operation. Adhesiolysis will be performed using bladder retro-fill with 300cc saline in the cystoinflation group, and without retro-fill in control.Both groups will be observed for bladder injury rate,bloodloss,operativetime,urinary tract infection,micturition problems and fistula formation.
Part2&3:Summary of Part 2 and 3 will be provided after publication
详细描述
Part1:Investigators will conduct this study to find the effectiveness of cystoinflation to prevent bladder injury in women with adhesions of previous C-sections. This prospective analytic longitudinal study will be conducted in Lady Willingdon Hospital, a tertiary care teaching hospital affiliated with King Edward Medical University Pakistan, from August 2017 to July 2019, after approval by the institutional review board of King Edward Medical University, Pakistan. The subjects will be randomly allocated to cystoinflation and control groups. The healthy pregnant women with previous operative deliveries admitted for elective C-section will be counselled and conditioned informed consent will be taken to be included in either study group if dense pelvic adhesions will be found during their operation. Adhesiolysis will be performed using bladder retro-fill with 300cc saline in the cystoinflation group, and without retro-fill in control. We will assess primary outcome by observing bladder injury rate, blood loss and operative time. The secondary outcome will be assessed by Urinary tract infection, micturition problems and fistula formation during 3month follow up period. The cystoinflation will be considered effective if the proportion of bladder injury in the study group will be less than 50% of the control group.
Part2&3:Details of part2&3 will be provided after publication
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants and outcome assessors are kept blind by just entering the random number assigned to the subject on the papers and notes are written without details of adhesiolysis. The completed outcome performas are sent to the assessors with the only random number entered and without the assigned group. The random number file is opened only after receiving results from the statistician. The care providers in theatre and principle surgeon cannot be blinded in this study.
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Part1:Inclusion Criteria:
- •• Healthy pregnant women of any age
- •Two or more previous C-sections
- •Gestational age between 38-40 weeks (confirmed by dating scan)
- •Dense Adhesions of Tulandi scores four or more.
- •women who give informed consent to participate in the study
排除标准
- •Patients with medical disorders
- •Bladder injury before group assignment
- •Placenta previa
- •Subjects experiencing micturition problems (dysuria, frequency, urgency, urinary retention, incontinence) before the study.
- •Eligibility criteria of part 2&3 will be provided after publication -
研究组 & 干预措施
Cystoinflation group
Bladder will be recognized by observing its gradual distension during bladder retro-fill with 300cc saline to perform adhesiolysis.
干预措施: Cystoinflation (Procedure)
Control group
Pelvic adhesiolysis will be performed without bladder retrofill.
结局指标
主要结局
Bladder Injury Rate
时间窗: From the confirmation of adhesions to adhesiolysis and separation of bladder flap from uterus, before delivery of the baby during cesarean section.This time frame can range between 10-20 minutes.
The bladder injury will be detected by direct visualization in the cesarean section before delivery of the baby during adhesiolysis of dense adhesions of the lower uterine segment, which cover and obscure the bladder. The bladder injury outcome will be measured as the number(percentage) of subjects with injury.
Blood Loss
时间窗: From the confirmation of adhesions to adhesiolysis and separation of bladder flap from uterus, before delivery of the baby during cesarean section.This time frame can range between 10-20 minutes.
Amount of blood loss during C-section will be increase in weight of sponges used during operation, taking 1gram equal to 1cc.
Operative Time
时间窗: During Caesarean section
Time from incision till closure of skin
次要结局
- White Blood Cells Count Per High Power Feild(3rd postoperative day)
- Urine Culture Report for Micro-organisms(2nd postoperative day)
- Fever(upto 3months)
- Postmicturition Bladder Volume After C-section(upto 3months)
- Composite Micturition Problems During Hospital Stay(Complaint recorded during hospital stay (range between 4-21 days))
- Duration of Urinary Catheterization(upto 3months)
- Duration of Hospital Stay(upto 3months)
- Number of Subjects With Urinary Fistula Formation(upto 3months)
- Composite Micturition Problems After Discharge(upto 3months)
研究者
Shazia Saaqib
Assistant Professor Gynecology and Obstetrics
King Edward Medical University