Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Bladder Injury; Complications; Cesarean Section; Adhesions Pelvic
• Intervention / Treatment: Procedure: Cystoinflation

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 564
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 042
      • Lady Willingdon Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Shazia Saaqib
• Collaborators: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: ERB#216/RC/KEMU; NCT#04302545 (Registry Identifier: Clinical trials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No: There is no plan to make individual participant data available. The data will be made available to individual researchers on request after publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No