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NCT Number: NCT04302545

Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery

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

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Key information

Conditions

Bladder Injury Adhesions Pelvic Complications; Cesarean Section

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lady Willingdon Hospital

Lahore, Punjab Province, 042, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Part1: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.

Eligibility criteria of part 2&3 will be provided after publication -

Treatment and study plan

Cystoinflation

Procedure

Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline

Other names: Bladder retrofill

Primary outcomes

  1. 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.

  2. 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.

  3. Operative Time

    Time frame: During Caesarean section

    Time from incision till closure of skin

Secondary outcomes

  1. White Blood Cells Count Per High Power Feild

    Time frame: 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

    Time frame: 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

    Time frame: upto 3months

    Number of patients who presented with fever during hospital stay

  4. Postmicturition Bladder Volume After C-section

    Time frame: 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

    Time frame: 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

    Time frame: upto 3months

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

  7. Duration of Hospital Stay

    Time frame: 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

    Time frame: upto 3months

    abnormal communication between genital tract nd urinary tract

  9. Composite Micturition Problems After Discharge

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shazia Saaqib

Other

Collaborators

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

Registry information

Official study title

Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery Part 1-Cystoinflation in Repeat C-section Part 2- Cystoinflation in Abdominal Hysterectomy Part3- Cystoinflation in Placenta Accreta Spectrum Management

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Mar 10, 2020
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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