Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

564 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2022-04-30

Brief Summary

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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

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Detailed Description

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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

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Bladder Injury Complications; Cesarean Section Adhesions Pelvic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The participants and outcome assessors are kept blind by just entering the random number assigned to the subject on the papers and notes are written without details of adhesiolysis. The completed outcome performas are sent to the assessors with the only random number entered and without the assigned group. The random number file is opened only after receiving results from the statistician. The care providers in theatre and principle surgeon cannot be blinded in this study.

Study Groups

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Cystoinflation group

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

Group Type EXPERIMENTAL

Cystoinflation

Intervention Type PROCEDURE

Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline

Control group

Pelvic adhesiolysis will be performed without bladder retrofill.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cystoinflation

Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline

Intervention Type PROCEDURE

Other Intervention Names

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Bladder retrofill

Eligibility Criteria

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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 -

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes