Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery

Shazia Saaqib

Status: Completed

Conditions: Bladder Injury; Adhesions Pelvic; Complications; Cesarean Section

Treatments: Procedure: Cystoinflation

Study type: Interventional

Funder types: Other

Identifiers

NCT04302545

ERB#216/RC/KEMU

NCT#04302545 (Registry Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 564 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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564 participants in 2 patient groups

Cystoinflation group

Experimental group

Description:

Bladder will be recognized by observing its gradual distension during bladder retro-fill with 300cc saline to perform adhesiolysis.

Treatment:

Procedure: Cystoinflation

Control group

No Intervention group

Description:

Pelvic adhesiolysis will be performed without bladder retrofill.