NCT04302545

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 564 (actual)
• Sponsor: Shazia Saaqib · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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

Conditions

• Bladder Injury
• Complications; Cesarean Section
• Adhesions Pelvic

Interventions

Type	Name	Description
PROCEDURE	Cystoinflation	Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline

Timeline

• Start date: 2017-08-01
• Primary completion: 2021-04-30
• Completion: 2022-04-30
• First posted: 2020-03-10
• Last updated: 2024-09-04
• Results posted: 2021-09-28

Locations

1 site across 1 country: Pakistan