A Randomized Controlled Trial of Cystoinflation to Prevent Bladder Injury in the Adhesive Disease of Multiple Caesarean Sections
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 214
- Locations
- 2
- Primary Endpoint
- Bladder Injury Rate
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Masking Description
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.
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Bladder Injury Rate
Time Frame: 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
Time Frame: 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
Time Frame: During Caesarean section
Time from incision till closure of skin
Secondary Outcomes
- 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)
Investigators
Shazia Saaqib
Assistant Professor Gynecology and Obstetrics
King Edward Medical University