Clinical trial NCT04302545: Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Injury
Complications; Cesarean Section
Adhesions Pelvic
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
Collaborators: name: King Edward Medical University
name: Institute of Public Health, Pakistan
First posted: 2020-03-10
Enrollment: 564
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

Brief summary: 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

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

Eligibility criteria: 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 -

Primary outcomes:
measure: Bladder Injury Rate
timeFrame: 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.
measure: Blood Loss
timeFrame: 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.
measure: Operative Time
timeFrame: During Caesarean section
Secondary outcomes:
measure: White Blood Cells Count Per High Power Feild
timeFrame: 3rd postoperative day
measure: Urine Culture Report for Micro-organisms
timeFrame: 2nd postoperative day
measure: Fever
timeFrame: upto 3months
measure: Postmicturition Bladder Volume After C-section
timeFrame: upto 3months
measure: Composite Micturition Problems During Hospital Stay
timeFrame: Complaint recorded during hospital stay (range between 4-21 days)
measure: Duration of Urinary Catheterization
timeFrame: upto 3months
measure: Duration of Hospital Stay
timeFrame: upto 3months
measure: Number of Subjects With Urinary Fistula Formation
timeFrame: upto 3months
measure: Composite Micturition Problems After Discharge
timeFrame: upto 3months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Lady Willingdon Hospital
state: Punjab
Study officials:
affiliation: King Edward Medical University
name: Munazza Naheed, MBBS
role: STUDY_DIRECTOR
affiliation: King Edward Medical University
name: Tayyaba Saeed, MBBS
role: STUDY_DIRECTOR
affiliation: Institute of Public Health, Pakistan
name: Mohammad Khalid, MBBS, MHM
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
citation: 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.