Cystoinflation to Prevent Bladder Injury in Multiple Caesarean Sections

Cesarean Section Complications Clinical Trial

Official title:

A Randomized Controlled Trial of Cystoinflation to Prevent Bladder Injury in the Adhesive Disease of Multiple Caesarean Sections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04302545
• Other study ID #: ERB#216/RC/KEMU
• Secondary ID: NCT#04302545
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2021
• Source: King Edward Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: July 31, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Adhesions Pelvic
• Bladder Injury
• Cesarean Section Complications
• Wounds and Injuries

Intervention

Procedure:
• Cystoinflation
Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline

Locations

Country	Name	City	State
Pakistan	Lady Willingdon Hospital	Lahore	Punjab

Sponsors (3)

Lead Sponsor	Collaborator
Shazia Saaqib	Institute of Public Health, Pakistan, King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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;(4):CD010322. doi: 10.1002/14651858.CD010322.pub2. Review — View Citation

Joelsson-Alm E, Nyman CR, Svensén 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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.
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.	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.
Primary	Operative Time	Time from incision till closure of skin	During Caesarean section
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.	3rd postoperative day
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.	2nd postoperative day
Secondary	Fever	Number of patients who presented with fever during hospital stay	upto 3months
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	upto 3months
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.	Complaint recorded during hospital stay (range between 4-21 days)
Secondary	Duration of Urinary Catheterization	The time interval for which subject will be kept catheterized postoperatively.	upto 3months
Secondary	Duration of Hospital Stay	The time interval in days from the date of operation till discharge from the hospital.	upto 3months
Secondary	Number of Subjects With Urinary Fistula Formation	abnormal communication between genital tract nd urinary tract	upto 3months
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.	upto 3months