Cystoinflation to Prevent Bladder Injury in Multiple Caesarean Sections

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of Cystoinflation to Prevent Bladder Injury in the Adhesive Disease of Multiple Caesarean Sections

Conditions
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Bladder Injury, Cesarean Section Complications, Adhesions Pelvic

Intervention / Treatment
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* Procedure: Cystoinflation


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria :• Patients with medical disorders Bladder injury before group assignment Placenta previa Subjects experiencing micturition problems (dysuria, frequency, urgency, urinary retention, incontinence) before the study.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be assigned into cystoinflation group and control group after parallel assignment. In the cystoinflation group, the intervention will be retro-fill of the bladder with 300cc saline and clamping the drainage port of the catheter till the completion of adhesiolysis. In contrast, the urinary catheter of control group patients will be put on free drainage. Each group will be further divided into bladder injury arm and distension arm(No bladder injury arm)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cystoinflation group<br>Bladder will be recognized by observing its gradual distension during bladder retro-fill with 300cc saline to perform adhesiolysis. | Procedure: Cystoinflation<br>* Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline<br>* Other names: Bladder retrofill;|
| No Intervention: Control group<br>Pelvic adhesiolysis will be performed without bladder retrofill. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder Injury Rate | 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. | 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. | 
| Blood Loss | Amount of blood loss during C-section will be increase in weight of sponges used during operation, taking 1gram equal to 1cc. | 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. | 
| Operative Time | Time from incision till closure of skin | During Caesarean section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White Blood Cells Count Per High Power Feild | The normal white cell count ranges between 4000-11000 per microlitre. The raised count is an indication of postoperative infection. | 3rd postoperative day | 
| Urine Culture Report for Micro-organisms | The outcome measure was the number(percentage) of subjects in which urine culture reports showed the growth of micro-organisms in the urine of the subjects sent for test on the second postoperative day. | 2nd postoperative day | 
| Fever | Number of patients who presented with fever during hospital stay | upto 3months | 
| Postmicturition Bladder Volume After C-section | Volume of urine retained in bladder after evacuation. Bladder distension will be diagnosed if volume retained in the bladder will be greater than 50cc measured on 4th postoperative day | upto 3months | 
| Composite Micturition Problems During Hospital Stay | The micturition problems during the hospital stay investigated in this study were dysuria, feeling of incomplete evacuation, frequency, urgency, urethral and extra-urethral incontinence), Dysuria was expressed by the subject as painful micturition using an 11point visual analogue Scale from zero to ten and converted into severity scores from 0-3. Score 0 or no point= 0 point on scale Score1 or mild pain=1-3point Score2 or Moderate Pain=4-6points; Score 3 or Severe Pain=.7-10 Other micturition problems (feeling of incomplete evacuation, frequency, urgency, urethral and extra-urethral incontinence) were measured subjectively on a 4point Likert scale questionnaire according to severity ranging from 0-3 (0-never, 1-rarely, 2-sometimes, and 3-often). The micturition problems of each subject were summed up as composite variables and both groups were compared for the mean value of the composite variable and standard deviation in spss20 statistical software. | Complaint recorded during hospital stay (range between 4-21 days) | 
| Duration of Urinary Catheterization | The time interval for which subject will be kept catheterized postoperatively. | upto 3months | 
| Duration of Hospital Stay | The time interval in days from the date of operation till discharge from the hospital. | upto 3months | 
| Number of Subjects With Urinary Fistula Formation | abnormal communication between genital tract nd urinary tract | upto 3months | 
| Composite Micturition Problems After Discharge | IT is composit Likert score(range from 0-3) of micturition problems recorded by patient after discharge from the hospital to the completion of 3months postoperative(follow up period).The lower value of the score is associated with good outcome while higher value shows a poor outcome. | upto 3months |