Cystoinflation to Prevent Bladder Injury in Multiple Caesarean Sections

• Sponsor: Shazia Saaqib (Other)
• Overall Status: Completed
• CT.gov ID: NCT04302545
• Collaborator: King Edward Medical University (Other), Institute of Public Health, Pakistan (Other)
• Enrollment: 214
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 8.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Injury; Cesarean Section Complications; Adhesions Pelvic	Procedure: Cystoinflation	N/A

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
• Actual Enrollment: 214 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)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 (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.
• Primary Purpose: Prevention
• Official Title: A Randomized Controlled Trial of Cystoinflation to Prevent Bladder Injury in the Adhesive Disease of Multiple Caesarean Sections
• Actual Study Start Date: Aug 1, 2017
• Actual Primary Completion Date: Apr 30, 2019
• Actual Study Completion Date: Jul 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Bladder Injury Rate [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.

2. Blood Loss [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.

3. Operative Time [During Caesarean section]

   Time from incision till closure of skin

Secondary Outcome Measures

1. White Blood Cells Count Per High Power Feild [3rd postoperative day]

   The normal white cell count ranges between 4000-11000 per microlitre. The raised count is an indication of postoperative infection.

2. Urine Culture Report for Micro-organisms [2nd postoperative day]

   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.

3. Fever [upto 3months]

   Number of patients who presented with fever during hospital stay

4. Postmicturition Bladder Volume After C-section [upto 3months]

   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

5. Composite Micturition Problems During Hospital Stay [Complaint recorded during hospital stay (range between 4-21 days)]

   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.

6. Duration of Urinary Catheterization [upto 3months]

   The time interval for which subject will be kept catheterized postoperatively.

7. Duration of Hospital Stay [upto 3months]

   The time interval in days from the date of operation till discharge from the hospital.

8. Number of Subjects With Urinary Fistula Formation [upto 3months]

   abnormal communication between genital tract nd urinary tract

9. Composite Micturition Problems After Discharge [upto 3months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lady Willingdon Hospital	Lahore	Punjab	Pakistan	042

Sponsors and Collaborators

• Shazia Saaqib
• King Edward Medical University
• Institute of Public Health, Pakistan

Investigators

• Study Director: Munazza Naheed, MBBS, King Edward Medical University
• Study Director: Tayyaba Saeed, MBBS, King Edward Medical University
• Study Director: Mohammad Khalid, MBBS, MHM, Institute of Public Health, Pakistan

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Mar 27, 2017

More Information

Publications

None provided.

• Responsible Party: Shazia Saaqib, Assistant Professor Gynecology and Obstetrics, King Edward Medical University
• ClinicalTrials.gov Identifier: NCT04302545
• Other Study ID Numbers: ERB#216/RC/KEMU; NCT#04302545
• First Posted: Mar 10, 2020
• Last Update Posted: Sep 28, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

Participant Flow

Recruitment Details

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.

Pre-assignment Detail

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.

Arm/Group Title	Distension Arm	Bladder Injury Arm
Arm/Group Description	Subjects with no bladder injury	Subjects with bladder injury
Period Title: Overall Study
STARTED	107	107
COMPLETED	104	103
NOT COMPLETED	3	4

Baseline Characteristics

Arm/Group Title	Cystoinflation Group	Control Group	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	107	107	214
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	107 100%	107 100%	214 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.19 (2.3)	31.73 (2.4)	31.96 (2.388)
Sex: Female, Male (Count of Participants)
Female	107 100%	107 100%	214 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	107 100%	107 100%	214 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Pakistan	107 100%	107 100%	207 96.7%
Parity (Count of Participants)
para2	35 32.7%	33 30.8%	68 31.8%
para3	60 56.1%	60 56.1%	120 56.1%
para4	10 9.3%	10 9.3%	20 9.3%
para5	2 1.9%	4 3.7%	6 2.8%
BMI kg/m^2 (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.73 (1.89)	30.54 (1.86)	30.635 (1.876)
Socioecnomic status (Count of Participants)
low (per capita family income <Rupees3000/month)	39 36.4%	41 38.3%	80 37.4%
medium (per capita family income<Rupees3000-5000/month	55 51.4%	54 50.5%	109 50.9%
high (per capita family income Rupees 5,000/month	13 12.1%	12 11.2%	25 11.7%
Number of previous C-sections (Count of Participants)
previous2	46 43%	43 40.2%	89 41.6%
previous3	52 48.6%	54 50.5%	106 49.5%
previous4	6 5.6%	7 6.5%	13 6.1%
previous5	3 2.8%	3 2.8%	6 2.8%
Score of adhesions (Count of Participants)
4	53 49.5%	56 52.3%	109 50.9%
8	38 35.5%	36 33.6%	74 34.6%
16	16 15%	15 14%	31 14.5%
Preoperative postmicturition bladder volume (ml) [Median (Full Range) ]
Median (Full Range) [ml]	15	20	15

Outcome Measures

1. Primary Outcome

Title	Bladder Injury Rate
Description	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.
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cystoinflation Group	Control Group
Arm/Group Description	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	Pelvic adhesiolysis will be performed without bladder retrofill.Outcome will be studied as bladder injury arm and Distension arm.
Measure Participants	107	107
Count of Participants [Participants]	3 2.8%	22 20.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cystoinflation Group, Control Group
	Comments	Null Hypothesis: During the cesarean section of women with adhesions of the previous cesarean section that obscure the bladder, the bladder injury rate is not significantly decreased in cystoinflation group compared to the control. In this study, the bladder injury rate was seven times lesser in cystoinflation group compared to the control, thereby strongly supporting our hypothesis. The power of the study for bladder injury was 0.988, calculated with statistical software G'Power version 3.1.
	Type of Statistical Test	Other
	Comments	Other Primary outcomes were the extent of injury, operative time, blood loss and proportion of subjects receiving a blood transfusion. Postoperatively, subjects were assessed for secondary outcomes of UTI, micturition problems, and fistula formation during the hospital stay and for the next 3 months. Postoperative micturition problems were feeling of incomplete evacuation, frequency, urgency, urethral and extra-urethral incontinence.
Statistical Test of Hypothesis	p-Value	<.0001
	Comments	The threshold for statistical significance was <.05.
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	-.178
	Confidence Interval	(2-Sided) 95%; -.261 to -.094
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Blood Loss
Description	Amount of blood loss during C-section will be increase in weight of sponges used during operation, taking 1gram equal to 1cc.
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cystoinflation Group	Control Group
Arm/Group Description	Bladder will be recognized by observing its gradual distension during bladder retro-fill with 300cc saline to perform adhesiolysis. Cystoinflation: Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline	Pelvic adhesiolysis will be performed without bladder retrofill.
Measure Participants	107	107
Mean (Standard Deviation) [ml]	585.32 (152.52)	797.10 (385.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cystoinflation Group, Control Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	-211.776
	Confidence Interval	(2-Sided) 95%; -290.70 to -132.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Operative Time
Description	Time from incision till closure of skin
Time Frame	During Caesarean section

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cystoinflation Group	Control Group
Arm/Group Description	Bladder will be recognized by observing its gradual distension during bladder retro-fill with 300cc.	Pelvic adhesiolysis will be performed without bladder retrofill.
Measure Participants	107	107
Mean (Standard Deviation) [minutes]	45 (8.66)	45 (16.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cystoinflation Group, Control Group
	Comments	Null Hypothsis:Cystoinflation is ineffective to prevent bladder injury in adhesions of previous C-section.The cystoinflation was to be cosidered ineffective if proportion of bladder injury in study group was less than %0% of the control.The power of the study for bladder injury prevention was.988,calculated with statistical software G'Power version3.1.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	1
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.000
	Confidence Interval	(2-Sided) 95%; -3.634 to 3.634
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	White Blood Cells Count Per High Power Feild
Description	The normal white cell count ranges between 4000-11000 per microlitre. The raised count is an indication of postoperative infection.
Time Frame	3rd postoperative day

Outcome Measure Data

Analysis Population Description

This analysis will be carried out in postoperative subjects of both groups.

Arm/Group Title	Cystinflation Group	Control Group
Arm/Group Description	Subjects in which adhesiolysis is performed after distending bladder with300cc saline.	Subjects in which adhesiolysis is performed with urinary catheter put on free drainage.
Measure Participants	107	107
Mean (Standard Deviation) [count/hpf]	6.26 (1.003)	7.36 (3.063)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cystoinflation Group, Control Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.001
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	-1.093
	Confidence Interval	(2-Sided) 95%; -1.708 to -.479
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Urine Culture Report for Micro-organisms
Description	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.
Time Frame	2nd postoperative day

Outcome Measure Data

Analysis Population Description

The population included all cases of both cystinflation group and control group.

Arm/Group Title	Cystoinflation Group	Control Group
Arm/Group Description	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	Pelvic adhesiolysis will be performed without bladder retrofill.Outcome will be studied as bladder injury arm and Distension arm.
Measure Participants	107	107
Count of Participants [Participants]	2 1.9%	18 16.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cystoinflation Group, Control Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	-.15
	Confidence Interval	(2-Sided) 95%; -0.226 to -0.073
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Fever
Description	Number of patients who presented with fever during hospital stay
Time Frame	upto 3months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cystoinflation Group	Control Group
Arm/Group Description	Subjects in which adhesiolysis is performed after distending bladder with 300cc saline.	Subjects in which adhesiolysis is performed by putting urinary catheter on free drainage
Measure Participants	107	107
Count of Participants [Participants]	2 1.9%	13 12.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cystoinflation Group, Control Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	-.103
	Confidence Interval	(2-Sided) 95%; -0.171 to -0.035
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Postmicturition Bladder Volume After C-section
Description	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
Time Frame	upto 3months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cystoinflation Group	Control Group
Arm/Group Description	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.	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.
Measure Participants	104	103
Mean (Standard Deviation) [ml]	15.56 (4.968)	14.91 (4.952)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cystoinflation Group, Control Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.336
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.654
	Confidence Interval	(2-Sided) 95%; -0.682 to 1.991
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Composite Micturition Problems During Hospital Stay
Description	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.
Time Frame	Complaint recorded during hospital stay (range between 4-21 days)

Outcome Measure Data

Analysis Population Description

Subjects of both cystoinflation and control groups during the postoperative hospital stay.

Arm/Group Title	Cystoinflation Group	Control Group
Arm/Group Description	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.	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.
Measure Participants	104	103
Mean (Standard Deviation) [score]	.077 (.633)	.47 (1.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cystoinflation Group, Control Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.021
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	-0.393
	Confidence Interval	(2-Sided) 95%; -0.725 to -0.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Duration of Urinary Catheterization
Description	The time interval for which subject will be kept catheterized postoperatively.
Time Frame	upto 3months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cystoinflation Group	Control Group
Arm/Group Description	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.	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.
Measure Participants	104	103
Mean (Standard Deviation) [Days]	1.25 (1.626)	3.14 (4.575)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cystoinflation Group, Control Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	-1.89
	Confidence Interval	(2-Sided) 95%; -2.813 to -0.963
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Duration of Hospital Stay
Description	The time interval in days from the date of operation till discharge from the hospital.
Time Frame	upto 3months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cystoinflation Group	Control Group
Arm/Group Description	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.	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.
Measure Participants	104	103
Mean (Standard Deviation) [Days]	4.18 (1.156)	5.50 (3.506)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cystoinflation Group, Control Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	-1.318
	Confidence Interval	(2-Sided) 95%; -2.021 to -0.614
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Number of Subjects With Urinary Fistula Formation
Description	abnormal communication between genital tract nd urinary tract
Time Frame	upto 3months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cystoinflation Group	Control Group
Arm/Group Description	The adhesiolysis will be carried out after retrograde bladder fill with 300cc saline.	The adhesiolysis will be carried out with urinary catheter put on free drainage.
Measure Participants	104	103
Count of Participants [Participants]	0 0%	1 0.9%

12. Secondary Outcome

Title	Composite Micturition Problems After Discharge
Description	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.
Time Frame	upto 3months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cystoinflation Group	Control Group
Arm/Group Description	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.	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.
Measure Participants	104	103
Mean (Standard Deviation) [score]	.0047 (.034)	.0701 (.222)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cystoinflation Group, Control Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.003
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	-.065
	Confidence Interval	(2-Sided) 95%; -.108 to -.023
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Follow up was carried out over a period of 3months.
Adverse Event Reporting Description	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.
Arm/Group Title	Cystoinflation Group		Control Group
Arm/Group Description	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.		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.
All Cause Mortality
	Cystoinflation Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/107 (0%)		0/107 (0%)
Serious Adverse Events
	Cystoinflation Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/107 (2.8%)		22/107 (20.6%)
Renal and urinary disorders
Bladder injury	3/107 (2.8%)	3	22/107 (20.6%)	22
Other (Not Including Serious) Adverse Events
	Cystoinflation Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/107 (0%)		1/107 (0.9%)
Renal and urinary disorders
vasicovaginal Fistula	0/107 (0%)	0	1/107 (0.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.