ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000414910

Ethics application status

Approved

Date submitted

19/04/2011

Date registered

20/04/2011

Date last updated

1/12/2021

Date data sharing statement initially provided

1/12/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Bladder Care Following Laparoscopy for Benign Non-Hysterectomy Gynaecological Conditions – A Randomised Controlled Trial

Scientific title

A randomised controlled trial of patients undergoing laparoscopic surgery for benign non-hysterectomy gynaecological conditions, randomising patients to either immediate removal of the urinary catheter or removal on the first post-operative day, comparing any difference in the rate of urinary tract infection and voiding dysfunction.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Post-operative bladder care following laparoscopy for benign non-hysterectomy gynaecological conditions

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

It is standard surgical practice to place an indwelling catheter during laparoscopy for gynaecological surgery to increase visualisation of the pelvic organs and to minimise the risk of intraoperative bladder injuries, in particular at the placement of the suprapubic laparoscopic port. It is the practice of some surgeons to leave the urinary catheter in situ post-operatively, whilst others remove the catheter immediately post-operatively.

The primary objective of this clinical investigation is to determine whether immediate removal of the urinary catheter after laparoscopic surgery for benign non-hysterectomy gynaecological conditions (excluding surgery for prolapse and urinary incontinence) will affect the rate of post-operative complications involving the urinary tract.

Patients in the immediate catheter removal group will have the urinary catheter removed in the operating theatre at the completion of surgery.

With regards to bladder function, the patient is considered fit for discharge when she is able to void >=150 ml on two successive occasions. Other factors may prevent discharge and these will be documented.

This reflects the current standard practice at many institutions after laparoscopy for benign gynaecological conditions (except prolapse and incontinence).

In addition to the above standard practice, study subjects allocated to this group will also have their PVR measured by bladder scan (in accordance to the parameters outlined above). Medical staff and the study subjects will be blinded from the results of the bladder scan. Accordingly, the decision for timing of hospital discharge is not influenced by the results of the bladder scan. This reflects the current standard practice at many institutions where bladder scans are not routinely performed after laparoscopy for benign gynaecological conditions.

Bladder scans may be performed when there is a clinical indication to measure the PVR (for example, when the subject is unable to void >=150 ml on two successive occasions). The results of these bladder scans, and how they influence the management and timing of hospital discharge, will be documented.

Intervention code [1]

Prevention

Comparator / control treatment

Patients in the delayed catheter removal group will have removal of the urinary catheter at 0600 hours day 1 post-operatively.

With regards to bladder function, the patient is considered fit for discharge when she is able to void >=150 ml and have PVR of <100 ml on two successive occasions. Other factors may prevent discharge and these will be documented.

On any occasion where the bladder scan determines the PVR to be >200 ml, an immediate temporary catheterisation will be performed with drainage and measurement of urine and then removal of the catheter. The PVR determined by catheterisation will be documented.

This reflects the current standard protocol of the Endo-Gynaecology Department at the Royal Hospital for Women, and of Dr Stephen Lyons at the Mater Hospital.

The method and technique of removal of the urinary catheter is the same in both the control and intervention groups.

Control group

Active

Outcomes

Primary outcome [1]

Incidence of post-operative urinary tract infection:
At the phone interview 10-14 days postoperatively, and at the 6 week postoperative clinic review, study subjects will be asked whether they have been diagnosed with a urinary tract infection, and whether they have had any unscheduled presentation to a general practitioner, emergency department, or outpatient service (clinic/rooms).

Timepoint [1]

Within 6 weeks post-operative

Primary outcome [2]

Incidence and pattern of post-operative voiding dysfunction:
At the 6 week postoperative clinic review, study subjects will complete two validated questionnaires regarding lower urinary tract symptoms (ICIQ-FLUTS and ICIQ-LUTSqol).

Timepoint [2]

Within 6 weeks post-operative

Secondary outcome [1]

Post-void residual urine volume (PVR) in patients before surgery, and to commence the development of a nomogram for the female population:
Upon admission to hospital for surgery, study subjects will:
- Complete the ICIQ-FLUTS questionnaire.
- Undergo independent (no catheter) uroflowmetry in a private room.
- Have a transabdominal bladder scan to measure the PVR
- Undergo a urinary pregnancy test;
- Provide a mid-stream urine (MSU) sample for urinalysis.

Timepoint [1]

Pre-operative

Secondary outcome [2]

Duration of hospital stay:
This will be calculated from the date and time of hospital admission and hospital discharge documented on the case report form and hospital medical records.

Timepoint [2]

Noted at time of discharge from hospital

Secondary outcome [3]

Readmission to hospital (incidence and indication):
At the phone interview 10-14 days postoperatively, and at the 6 week postoperative clinic review, study subjects will be asked whether they have had any unscheduled presentation to a general practitioner, emergency department, or outpatient service (clinic/rooms). Permission will be sought to obtain further information from other health practitioners regarding these presentations/hospital admissions.

Timepoint [3]

Within 6 weeks post-operative

Secondary outcome [4]

Unscheduled presentation to General practitioner, Emergency department, Outpatient service (clinic/rooms):
At the phone interview 10-14 days postoperatively, and at the 6 week postoperative clinic review, study subjects will be asked whether they have been diagnosed with a urinary tract infection, and whether they have had any unscheduled presentation to a general practitioner, emergency department, or outpatient service (clinic/rooms).

Timepoint [4]

Within 6 weeks post-operative

Secondary outcome [5]

Economic analyses of the two modalities for care

Timepoint [5]

Costs of hospitalisation and nursing care, calculated from time of admission to time of hospital discharge

Eligibility

Key inclusion criteria

- Elective laparoscopy for a benign gynaecological condition
- Patients to be aged >=18 years at time of surgery
- Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up
- Patients who are capable of, and have given written informed consent to their participation in the study.
- Patients presenting with benign gynaecological conditions that require surgical intervention as agreed to by the patient and her attending medical team.

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

- Concurrent involvement in other research studies
- Past history of incontinence surgery
- Surgery for urinary incontinence or prolapse
- Suspected or confirmed gynaecological malignancy
- Patients scheduled for hysterectomy as part of their surgical procedure
- Patients with long-term bladder catheterisation (intermittent or permanent)
- Suspected or confirmed pregnancy at the time of surgery
- Intermittent flow pattern on uroflowmetry (indicative of pre-existing voiding dysfunction)
- Preoperative PVR >=150 ml

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Patients will be considered for enrolment according to their clinical findings and subject to gaining suitable informed consent for a surgical procedure for benign gynaecological indications that has been discussed and agreed to with the patient.

Prior to enrolment each patient will be screened for eligibility according to the inclusion and exclusion criteria. All patients eligible for the study who give their written informed consent will be enrolled in the study with randomisation occurring intraoperatively.

Telephone randomisation will be centrally co-ordinated for all participating centres to ensure adequate concealment.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Group allocation will be according to a computer generated randomisation schedule, stratified by centre. Randomisation will occur in balanced blocks of 20.

At the determination of appropriate inclusion in the study as documented by the pathology present and the perceived need for a duration of at least an overnight hospital stay, the surgeon (or his/her delegate) will contact the central trial centre by telephone where a research associate will ensure inclusion and exclusion criteria are met, enter patient details into the database, and inform the investigator of the patient’s study number and allocation group.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

The investigator, patient and staff will not be blinded to the patient’s allocated study group, due to the obvious nature of the study intervention and the inability to have placebo catheterisation.

The investigator, patient and staff (excluding the nurse performing the bladder scan) will be blinded from the results of the PVR in the immediate catheter removal group, except where measurement of the PVR is clinically indicated.

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/03/2012

Actual

13/04/2012

Date of last participant enrolment

Anticipated

Actual

18/12/2019

Date of last data collection

Anticipated

Actual

20/02/2020

Sample size

Target

690

Accrual to date

Final

866

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2031

Recruitment postcode(s) [2]

2060

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

AGES Research Grant

Address [1]

Conference Connection
282 Edinburgh Road
CASTLECRAG NSW 2068

Country [1]

Australia

Primary sponsor type

Individual

Name

Associate Professor Jason Abbott

Address

Royal Hospital for Women
Barker Street
Randwick NSW 2031

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

nil

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Easter Sydney Local Health District - Human Research Ethics Committee - Northern Sector

Ethics committee address [1]

Prince of Wales Hospital
G71 East Wing, Edmund Blacket Building
Cnr High & Avoca Streets
Randwick NSW 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/04/2011

Approval date [1]

24/01/2012

Ethics approval number [1]

EC00134

Ethics committee name [2]

St Vincent's Hospital Human Research Ethics Committee

Ethics committee address [2]

Level 6, de Lacy Building
 St Vincent's Hospital
 390 Victoria Street,
 Darlinghurst NSW 2010

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

04/05/2011

Approval date [2]

Ethics approval number [2]

EC00140

Summary

Brief summary

It is a standard part of performing keyhole surgery (laparoscopy) in gynaecology to insert a urinary catheter at the time of surgery.  

The optimal time to remove this urinary catheter is unknown.  Some surgeons remove it immediately, whilst others keep the urinary catheter for some time (usually until the next day).  The duration for which the urinary catheter is left in may have an effect on post-operative lower urinary tract symptoms and complications, such urinary tract infections and difficulty emptying the bladder.

Up to 2 in 10 women may have difficulty passing urine or emptying the bladder properly after surgery.  It is hypothesised that earlier removal of the urinary catheter after surgery may potentially increase the risk of this happening.  Around 1 in 10 women may get a urinary tract infection after surgery.  It is hypothesised that the risk of this occurring may be increased if the urinary catheter is left in for longer durations, or if a woman has difficulty emptying her bladder properly after surgery.

Moreover, it is unknown as to what is the best means to assess whether a woman is emptying her bladder properly before being discharged from hospital after keyhole surgery.  In the Department of Endo-Gynaecology at the Royal Hospital for Women and for patients of Dr Stephen Lyons at the Mater Hospital, there is a standard protocol where, after removal of the urinary catheter, women undergo serial bladder scans to measure the volume of urine left inside the bladder after voiding (post void residual urine volume, PVR).  Women are not discharged from hospital until they are able to void at least 150 ml of urine on 2 consecutive occasions, and have a PVR of <100 ml after each of these voids.

In contrast at many other institutions, no such protocol exists, and women are eligible for discharge from hospital without undergoing any bladder scans.  It is hypothesised that women who are discharged from hospital with undiagnosed difficulty in emptying their bladder properly after their keyhole surgery may potentially have a higher risk of developing urinary tract infection and lower urinary tract symptoms.

The objective of the study is to test these hypotheses, and thus allow more evidence-based practice in bladder care after gynaecological laparoscopy.

This study is a prospective, randomised, multi-centre, clinical study, enrolling 690 women undergoing gynaecological laparoscopic surgery for benign indications, who would usually be expected to stay overnight due to their surgery.  Women randomised to the study will have their scheduled surgery according to their treating team’s recommendations.

Before surgery, subjects will complete a validated questionnaire regarding urinary symptoms and have a urine test to look for urinary tract infection.  They will also be asked to void into a special device which will measure the rate and volume of urine flow (uroflowmetry), and a PVR will be measured.

At the time of surgery, women will be randomised to one of two equally sized groups.  One group of women will have the urinary catheter removed at 0600 hours on the morning after their surgery.  This group of women will be managed according to the current standard protocol of the Department of Endo-Gynaecology at the Royal Hospital for Women.

The other group of women will have the urinary catheter removed immediately at the end of surgery.  This group of women will be eligible for discharge from hospital when they are able to void at least 150 ml on 2 consecutive occasions.  These women will also undergo bladder scans after voiding, but the results of the bladder scan will be blinded from the staff and patient, and will not influence the decision for hospital discharge.

After surgery, all women will be followed for 6 weeks post-operatively with health care visits and have their urinary function monitored. Permission will be sought from subjects for follow-up at 1 year after surgery.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Jason Abbott

Address

Royal Hospital for Women
Barker Street
Randwick NSW 2031

Country

Australia

Phone

+61 2 93826111

Fax

j.abbott@unsw.edu.au

Contact person for public queries

Name

Jason Abbott

Address

Royal Hospital for Women
Barker Street
Randwick NSW 2031

Country

Australia

Phone

+61 2 93826111

Fax

j.abbott@unsw.edu.au

Contact person for scientific queries

Name

Associate Professor Jason Abbott

Address

Royal Hospital for Women
Barker Street
Randwick NSW 2031

Country

Australia

Phone

+61 2 93826111

Fax

j.abbott@unsw.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Cleaned dataset available

When will data be available (start and end dates)?

1/10/2021-1/10/2026

Available to whom?

Available via public data repository

Available for what types of analyses?

Meta-analyses

How or where can data be obtained?

UNSW research data repository:
https://resdata.unsw.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Email
14299	Study protocol	j.abbott@unsw.edu.au
14300	Statistical analysis plan	j.abbott@unsw.edu.au
14301	Informed consent form	j.abbott@unsw.edu.au
14302	Ethical approval	j.abbott@unsw.edu.au

Results publications and other study-related documents

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