Trial Outcomes & Findings for Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery (NCT NCT04302545)
NCT ID: NCT04302545
Last Updated: 2024-09-04
Results Overview
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.
COMPLETED
NA
564 participants
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.
2024-09-04
Participant Flow
The study was carried out in King Edward Medical University affiliated hospital/Lady Willingdon Hospital for a period of two years starting from August 1,2017 to July31,2019 including a 3month follow up period.
Subjects admitted with full term pregnancy and previous 2 C-sections n=734 The study subjects were selected in two step assessment(a)preoperative (during operation). preoperatively Excluded n=346 due to medical disorders, placenta previa, bladder injury before group assignment, micturition problems before operation Declined to participate=5 During operation Excluded=174 as criteria of dense adhesions of bladder was not met with.
Participant milestones
| Measure |
Distension Arm
Subjects with no bladder injury
|
Bladder Injury Arm
Subjects with bladder injury
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
107
|
|
Overall Study
COMPLETED
|
104
|
103
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Distension Arm
Subjects with no bladder injury
|
Bladder Injury Arm
Subjects with bladder injury
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
Baseline Characteristics
Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery
Baseline characteristics by cohort
| Measure |
Cystoinflation Group
n=107 Participants
Cystoinflation: Bladder will be retro-filled with 300cc saline to distend the bladder to recognize bladder outline in cystoinflation group whenever dense adhesions will be encountered which obscure the bladder either before or after opening the peritoneal cavity. Bladder outline will be recognized by observing its gradual distension during bladder retro-fill .The outcome of cystoinflation group will be divided into distension arm(no bladder injury arm) and bladder injury arm.
|
Control Group
n=107 Participants
In control group,Pelvic adhesiolysis will be performed with bladder put on free drainage by urinary catheter.The outcome of control arm will be divided into distension arm(no bladder injury arm) and bladder injury arm.
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
107 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.19 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
31.73 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
31.96 years
STANDARD_DEVIATION 2.388 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
107 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Pakistan
|
107 participants
n=5 Participants
|
107 participants
n=7 Participants
|
207 participants
n=5 Participants
|
|
Parity
para2
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Parity
para3
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Parity
para4
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Parity
para5
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
BMI kg/m^2
|
30.73 kg/m^2
STANDARD_DEVIATION 1.89 • n=5 Participants
|
30.54 kg/m^2
STANDARD_DEVIATION 1.86 • n=7 Participants
|
30.635 kg/m^2
STANDARD_DEVIATION 1.876 • n=5 Participants
|
|
Socioecnomic status
low (per capita family income <Rupees3000/month)
|
39 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Socioecnomic status
medium (per capita family income<Rupees3000-5000/month
|
55 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Socioecnomic status
high (per capita family income Rupees 5,000/month
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Number of previous C-sections
previous2
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Number of previous C-sections
previous3
|
52 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Number of previous C-sections
previous4
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Number of previous C-sections
previous5
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Score of adhesions
4
|
53 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Score of adhesions
8
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Score of adhesions
16
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Preoperative postmicturition bladder volume
|
15 ml
n=5 Participants
|
20 ml
n=7 Participants
|
15 ml
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Cystoinflation Group
n=107 Participants
Cystoinflation: Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline.
Outcome will be studied as bladder injury arm and Distension arm
|
Control Group
n=107 Participants
Pelvic adhesiolysis will be performed without bladder retrofill.Outcome will be studied as bladder injury arm and Distension arm.
|
|---|---|---|
|
Bladder Injury Rate
|
3 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Cystoinflation Group
n=107 Participants
Cystoinflation: Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline.
Outcome will be studied as bladder injury arm and Distension arm
|
Control Group
n=107 Participants
Pelvic adhesiolysis will be performed without bladder retrofill.Outcome will be studied as bladder injury arm and Distension arm.
|
|---|---|---|
|
Blood Loss
|
585.32 ml
Standard Deviation 152.52
|
797.10 ml
Standard Deviation 385.09
|
PRIMARY outcome
Timeframe: During Caesarean sectionTime from incision till closure of skin
Outcome measures
| Measure |
Cystoinflation Group
n=107 Participants
Cystoinflation: Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline.
Outcome will be studied as bladder injury arm and Distension arm
|
Control Group
n=107 Participants
Pelvic adhesiolysis will be performed without bladder retrofill.Outcome will be studied as bladder injury arm and Distension arm.
|
|---|---|---|
|
Operative Time
|
45 minutes
Standard Deviation 8.66
|
45 minutes
Standard Deviation 16.99
|
SECONDARY outcome
Timeframe: 3rd postoperative dayPopulation: This analysis will be carried out in postoperative subjects of both groups.
The normal white cell count ranges between 4000-11000 per microlitre. The raised count is an indication of postoperative infection.
Outcome measures
| Measure |
Cystoinflation Group
n=107 Participants
Cystoinflation: Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline.
Outcome will be studied as bladder injury arm and Distension arm
|
Control Group
n=107 Participants
Pelvic adhesiolysis will be performed without bladder retrofill.Outcome will be studied as bladder injury arm and Distension arm.
|
|---|---|---|
|
White Blood Cells Count Per High Power Feild
|
6.26 count/hpf
Standard Deviation 1.003
|
7.36 count/hpf
Standard Deviation 3.063
|
SECONDARY outcome
Timeframe: 2nd postoperative dayPopulation: The population included all cases of both cystinflation group and control group.
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.
Outcome measures
| Measure |
Cystoinflation Group
n=107 Participants
Cystoinflation: Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline.
Outcome will be studied as bladder injury arm and Distension arm
|
Control Group
n=107 Participants
Pelvic adhesiolysis will be performed without bladder retrofill.Outcome will be studied as bladder injury arm and Distension arm.
|
|---|---|---|
|
Urine Culture Report for Micro-organisms
|
2 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: upto 3monthsNumber of patients who presented with fever during hospital stay
Outcome measures
| Measure |
Cystoinflation Group
n=107 Participants
Cystoinflation: Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline.
Outcome will be studied as bladder injury arm and Distension arm
|
Control Group
n=107 Participants
Pelvic adhesiolysis will be performed without bladder retrofill.Outcome will be studied as bladder injury arm and Distension arm.
|
|---|---|---|
|
Fever
|
2 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: upto 3monthsVolume 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
Outcome measures
| Measure |
Cystoinflation Group
n=104 Participants
Cystoinflation: Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline.
Outcome will be studied as bladder injury arm and Distension arm
|
Control Group
n=103 Participants
Pelvic adhesiolysis will be performed without bladder retrofill.Outcome will be studied as bladder injury arm and Distension arm.
|
|---|---|---|
|
Postmicturition Bladder Volume After C-section
|
15.56 ml
Standard Deviation 4.968
|
14.91 ml
Standard Deviation 4.952
|
SECONDARY outcome
Timeframe: Complaint recorded during hospital stay (range between 4-21 days)Population: Subjects of both cystoinflation and control groups during the postoperative 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.
Outcome measures
| Measure |
Cystoinflation Group
n=104 Participants
Cystoinflation: Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline.
Outcome will be studied as bladder injury arm and Distension arm
|
Control Group
n=103 Participants
Pelvic adhesiolysis will be performed without bladder retrofill.Outcome will be studied as bladder injury arm and Distension arm.
|
|---|---|---|
|
Composite Micturition Problems During Hospital Stay
|
.077 score
Standard Deviation .633
|
.47 score
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: upto 3monthsThe time interval for which subject will be kept catheterized postoperatively.
Outcome measures
| Measure |
Cystoinflation Group
n=104 Participants
Cystoinflation: Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline.
Outcome will be studied as bladder injury arm and Distension arm
|
Control Group
n=103 Participants
Pelvic adhesiolysis will be performed without bladder retrofill.Outcome will be studied as bladder injury arm and Distension arm.
|
|---|---|---|
|
Duration of Urinary Catheterization
|
1.25 Days
Standard Deviation 1.626
|
3.14 Days
Standard Deviation 4.575
|
SECONDARY outcome
Timeframe: upto 3monthsThe time interval in days from the date of operation till discharge from the hospital.
Outcome measures
| Measure |
Cystoinflation Group
n=104 Participants
Cystoinflation: Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline.
Outcome will be studied as bladder injury arm and Distension arm
|
Control Group
n=103 Participants
Pelvic adhesiolysis will be performed without bladder retrofill.Outcome will be studied as bladder injury arm and Distension arm.
|
|---|---|---|
|
Duration of Hospital Stay
|
4.18 Days
Standard Deviation 1.156
|
5.50 Days
Standard Deviation 3.506
|
SECONDARY outcome
Timeframe: upto 3monthsabnormal communication between genital tract nd urinary tract
Outcome measures
| Measure |
Cystoinflation Group
n=104 Participants
Cystoinflation: Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline.
Outcome will be studied as bladder injury arm and Distension arm
|
Control Group
n=103 Participants
Pelvic adhesiolysis will be performed without bladder retrofill.Outcome will be studied as bladder injury arm and Distension arm.
|
|---|---|---|
|
Number of Subjects With Urinary Fistula Formation
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: upto 3monthsIT 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.
Outcome measures
| Measure |
Cystoinflation Group
n=104 Participants
Cystoinflation: Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline.
Outcome will be studied as bladder injury arm and Distension arm
|
Control Group
n=103 Participants
Pelvic adhesiolysis will be performed without bladder retrofill.Outcome will be studied as bladder injury arm and Distension arm.
|
|---|---|---|
|
Composite Micturition Problems After Discharge
|
.0047 score
Standard Deviation .034
|
.0701 score
Standard Deviation .222
|
Adverse Events
Cystoinflation Group
Control Group
Serious adverse events
| Measure |
Cystoinflation Group
n=107 participants at risk
Cystoinflation: Bladder will be retro-filled with 300cc saline to distend the bladder to recognize bladder outline in cystoinflation group whenever dense adhesions will be encountered which obscure the bladder either before or after opening the peritoneal cavity. Bladder outline will be recognized by observing its gradual distension during bladder retro-fill .The outcome of cystoinflation group will be divided into distension arm(no bladder injury arm) and bladder injury arm.
|
Control Group
n=107 participants at risk
In control group,Pelvic adhesiolysis will be performed with bladder put on free drainage by urinary catheter.The outcome of control arm will be divided into distension arm(no bladder injury arm) and bladder injury arm.
|
|---|---|---|
|
Renal and urinary disorders
Bladder injury
|
2.8%
3/107 • Number of events 3 • Follow up was carried out over a period of 3months.
Fortunately, there was no mortality as the population were young, healthy, adult women and all the women with medical disorders and surgical complications were excluded. The women with adhesions of previous C-section were at risk of bladder injury, excessive haemorrhage due to prolonged surgery..All the bladder injury cases were entered in the adverse event register of the study.
|
20.6%
22/107 • Number of events 22 • Follow up was carried out over a period of 3months.
Fortunately, there was no mortality as the population were young, healthy, adult women and all the women with medical disorders and surgical complications were excluded. The women with adhesions of previous C-section were at risk of bladder injury, excessive haemorrhage due to prolonged surgery..All the bladder injury cases were entered in the adverse event register of the study.
|
Other adverse events
| Measure |
Cystoinflation Group
n=107 participants at risk
Cystoinflation: Bladder will be retro-filled with 300cc saline to distend the bladder to recognize bladder outline in cystoinflation group whenever dense adhesions will be encountered which obscure the bladder either before or after opening the peritoneal cavity. Bladder outline will be recognized by observing its gradual distension during bladder retro-fill .The outcome of cystoinflation group will be divided into distension arm(no bladder injury arm) and bladder injury arm.
|
Control Group
n=107 participants at risk
In control group,Pelvic adhesiolysis will be performed with bladder put on free drainage by urinary catheter.The outcome of control arm will be divided into distension arm(no bladder injury arm) and bladder injury arm.
|
|---|---|---|
|
Renal and urinary disorders
vasicovaginal Fistula
|
0.00%
0/107 • Follow up was carried out over a period of 3months.
Fortunately, there was no mortality as the population were young, healthy, adult women and all the women with medical disorders and surgical complications were excluded. The women with adhesions of previous C-section were at risk of bladder injury, excessive haemorrhage due to prolonged surgery..All the bladder injury cases were entered in the adverse event register of the study.
|
0.93%
1/107 • Number of events 1 • Follow up was carried out over a period of 3months.
Fortunately, there was no mortality as the population were young, healthy, adult women and all the women with medical disorders and surgical complications were excluded. The women with adhesions of previous C-section were at risk of bladder injury, excessive haemorrhage due to prolonged surgery..All the bladder injury cases were entered in the adverse event register of the study.
|
Additional Information
Shazia Saaqib
King Edward Medical University, Lahore, Pakistan
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place