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| ID | Type | Description | Link |
|---|---|---|---|
| NCT#04302545 | Registry Identifier | Clinical trials.gov |
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| Name | Class |
|---|---|
| King Edward Medical University | OTHER |
| Institute of Public Health, Pakistan | OTHER |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cystoinflation group | Experimental | Bladder will be recognized by observing its gradual distension during bladder retro-fill with 300cc saline to perform adhesiolysis. |
|
| Control group | No Intervention | Pelvic adhesiolysis will be performed without bladder retrofill. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cystoinflation | Procedure | Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline |
|
| 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 |
| 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 |
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Part1:Inclusion Criteria:
• Healthy pregnant women of any age
Exclusion Criteria
:• Patients with medical disorders
Eligibility criteria of part 2&3 will be provided after publication -
part1:Pregnant women Part2:Assigned to abdominal hysterectomy Part3:pregnant women with placenta accreta spectrum
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lady Willingdon Hospital | Lahore | Punjab Province | 042 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19138575 | Result | O'Hanlan KA. Cystosufflation to prevent bladder injury. J Minim Invasive Gynecol. 2009 Mar-Apr;16(2):195-7. doi: 10.1016/j.jmig.2008.11.011. Epub 2009 Jan 9. | |
| 26500959 | Result | Pandey D, Mehta S, Grover A, Goel N. Indwelling Catheterization in Caesarean Section: Time To Retire It! J Clin Diagn Res. 2015 Sep;9(9):QC01-4. doi: 10.7860/JCDR/2015/13495.6415. Epub 2015 Sep 1. |
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No: There is no plan to make individual participant data available. The data will be made available to individual researchers on request after publication.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Distension Arm | Subjects with no bladder injury |
| FG001 | Bladder Injury Arm | Subjects with bladder injury |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This study included Pakistani women eighteen years and above, coming to Lady Willingdon hospital for elective caesarean section due to the previous two or more C-sections, with no major medical disorder and found to have dense bladder adhesions on opening the abdomen; recognition of bladder was difficult due to overlying adhesions
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| ID | Title | Description |
|---|---|---|
| BG000 | Cystoinflation Group | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | 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. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cystoinflation Group | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder injury | Renal and urinary disorders | urinary Fistula | Systematic Assessment | abnormal communication between genital tract and urinary system |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vasicovaginal Fistula | Renal and urinary disorders | VVF | Non-systematic Assessment | injury to the urinary system during adhesiolysis of previous 2 or more C-sections |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shazia Saaqib | King Edward Medical University, Lahore, Pakistan | +92-3214708583 | shaziasaaqib@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 27, 2017 | Mar 14, 2021 | Prot_SAP_ICF_000.pdf |
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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.
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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.
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 |
| 24729285 | Result | Abdel-Aleem H, Aboelnasr MF, Jayousi TM, Habib FA. Indwelling bladder catheterisation as part of intraoperative and postoperative care for caesarean section. Cochrane Database Syst Rev. 2014 Apr 11;2014(4):CD010322. doi: 10.1002/14651858.CD010322.pub2. |
| 25350541 | Result | Joelsson-Alm E, Nyman CR, Svensen C, Ulfvarson J. Micturition problems after bladder distension during hospitalization in Sweden: "I'm not ill, just damaged for the rest of my life". Nurs Res. 2014 Nov-Dec;63(6):418-25. doi: 10.1097/NNR.0000000000000057. |
| 40670452 | Derived | Saaqib S, Naheed M, Iqbal A, Rehman RMAU, Khalid M. Evaluating a novel approach to placenta accreta spectrum management: the modified Triple-P technique with cystoinflation (a randomized controlled trial). Sci Rep. 2025 Jul 16;15(1):25870. doi: 10.1038/s41598-025-07582-6. |
| BG001 | Control Group | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Parity | Count of Participants | Participants |
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| BMI kg/m^2 | Mean | Standard Deviation | kg/m^2 |
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| Socioecnomic status | Count of Participants | Participants |
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| Number of previous C-sections | Count of Participants | Participants |
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| Score of adhesions | Dense adhesions were classified according to Tulandi score of adhesions. Adhesions less than 3cm scored 4. Adhesions between3-6cm scored as 8. Adhesion of .6cm scored as 16. | Count of Participants | Participants |
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| Preoperative postmicturition bladder volume | Median | Full Range | ml |
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Pelvic adhesiolysis will be performed without bladder retrofill.Outcome will be studied as bladder injury arm and Distension arm. |
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| Primary | Blood Loss | Amount of blood loss during C-section will be increase in weight of sponges used during operation, taking 1gram equal to 1cc. | Posted | Mean | Standard Deviation | ml | 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. |
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| Primary | Operative Time | Time from incision till closure of skin | Posted | Mean | Standard Deviation | minutes | During Caesarean section |
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| Secondary | 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. | This analysis will be carried out in postoperative subjects of both groups. | Posted | Mean | Standard Deviation | count/hpf | 3rd postoperative day |
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| Secondary | 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. | The population included all cases of both cystinflation group and control group. | Posted | Count of Participants | Participants | 2nd postoperative day |
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| Secondary | Fever | Number of patients who presented with fever during hospital stay | Posted | Count of Participants | Participants | upto 3months |
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| Secondary | 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 | Posted | Mean | Standard Deviation | ml | upto 3months |
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| Secondary | 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. | Subjects of both cystoinflation and control groups during the postoperative hospital stay. | Posted | Mean | Standard Deviation | score | Complaint recorded during hospital stay (range between 4-21 days) |
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| Secondary | Duration of Urinary Catheterization | The time interval for which subject will be kept catheterized postoperatively. | Posted | Mean | Standard Deviation | Days | upto 3months |
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| Secondary | Duration of Hospital Stay | The time interval in days from the date of operation till discharge from the hospital. | Posted | Mean | Standard Deviation | Days | upto 3months |
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| Secondary | Number of Subjects With Urinary Fistula Formation | abnormal communication between genital tract nd urinary tract | Posted | Count of Participants | Participants | upto 3months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score | upto 3months |
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| 0 |
| 107 |
| 3 |
| 107 |
| 0 |
| 107 |
| EG001 | Control Group | 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. | 0 | 107 | 22 | 107 | 1 | 107 |
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