Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000109303
Ethics application status
Approved
Date submitted
19/02/2008
Date registered
27/02/2008
Date last updated
27/02/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparative, single-blind, randomised trial of pain and ultrasound estimation of residual pelvic fluid associated with suction or non-suction drains following gynaecological laparoscopy
Scientific title
A comparative, single-blind, randomised trial of pain and ultrasound estimation of residual pelvic fluid associated with suction or non-suction drains following gynaecological laparoscopy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gynaecological laparoscopic procedure for resection of stage I-IV endometriosis, hysterectomy, myomectomy, salpingectomy, oophorectomy, cystectomy, urethropexy, adhesiolysis or any combination of these surgeries who would require postoperative drainage 2847 0
Condition category
Condition code
Surgery 2979 2979 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who are determined to require post-operative drainage will be allocated to receive either a suction or non-suction #14FC Bellovac drain (AstraTech, Sweden). Drains are inserted at the end of the procedure through the left-lateral port site. The drain is removed by nursing staff following medical review by the surgical team. The duration the drain is left in situ is dependent upon medical review.
Intervention code [1] 2575 0
Treatment: Devices
Comparator / control treatment
There will be two groups, suction and non-suction drainage, both groups will receive a drain. The vacuum pack of the Bellovac drain will be compressed in patients randomised to suction and will be left open in the non-suction group
Control group
Active

Outcomes
Primary outcome [1] 3856 0
Pain associated with wearing of drain via visual analogue scale (VAS) and verbal descriptor scale (VDS)
Timepoint [1] 3856 0
Immediately prior to drain removal
Primary outcome [2] 3857 0
Pain associated with removal of drain via VAS and VDS
Timepoint [2] 3857 0
During drain removal
Primary outcome [3] 3858 0
Pain following removal of drain via VAS and VDS
Timepoint [3] 3858 0
Immediately after drain removal
Secondary outcome [1] 6491 0
Nausea associated with wearing and removal of pelvic drains and following drain removal
Timepoint [1] 6491 0
Immediately prior, during and immediately after drain removal
Secondary outcome [2] 6570 0
Transvaginal ultrasound estimation of residual pelvic fluid
Timepoint [2] 6570 0
When considered medically appropriate to remove the drain, a transvaginal ultrasound will be performed

Eligibility
Key inclusion criteria
Women undergoing a laparoscopic procedure for resection of stage I-IV endometriosis, hysterectomy, myomectomy, salpingectomy, oophorectomy, cystectomy, urethropexy, adhesiolysis or any combination of these surgeries who would possibly require post-operative drainage were approached for inclusion in the study; female aged 18-80; fluent in spoken and written English, able to understand implications of their involvement in the study and those who consent to involvement in the study.
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include patients who may become distressed due to involvement in the study, intercurrent conditions precluding participation, known or suspected pregnancy and known or suspected gynecological malignancy. Women who have not been previously sexually active will be excluded from transvaginal ultrasound assessment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be approached at pre-operative clinical visits and will be provided with a Patient Information Sheet and Consent Form. The aims, procedure and risks of the study will be explained by the investigator and patients will be provided with the opportunity to discuss concerns before informed consent is obtained.
All subjects who are determined to require post-operative drainage will be allocated to suction or non-suction drainage.
All subjects who are determined to require post-operative drainage will be allocated to suction or non-suction drainage. Randomisation slips will be placed in sequential opaque envelopes displaying only the randomisation number. Envelopes will remain unopened until the surgeon makes the decision to use a drain. Envelopes will then be opened sequentially and the surgeon will be provided with the subjects’ group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocations were provided using computer-generated randomisation blocks to ensure complete randomisation across demographic fields and to provide a balanced data pool across both groups throughout the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A subset of approximately 40 women were approached from 1/06/2007 to undergo transvaginal assessment.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 778 0
2031

Funding & Sponsors
Funding source category [1] 3098 0
Other Collaborative groups
Name [1] 3098 0
Department of Endo-Gynaecology
Country [1] 3098 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Department of Endo-Gynaecology
Address
Royal Hospital for Women
Barker St, Randwick, NSW
Australia, 2031
Country
Australia
Secondary sponsor category [1] 2790 0
None
Name [1] 2790 0
Address [1] 2790 0
Country [1] 2790 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5070 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 5070 0
University of New South Wales
Randwick, 2031
Ethics committee country [1] 5070 0
Australia
Date submitted for ethics approval [1] 5070 0
Approval date [1] 5070 0
15/08/2006
Ethics approval number [1] 5070 0
Ethics committee name [2] 5071 0
South Eastern Sydney Area Health Service Human Research Ethics Committee ? Eastern Section
Ethics committee address [2] 5071 0
Ethics committee country [2] 5071 0
Australia
Date submitted for ethics approval [2] 5071 0
Approval date [2] 5071 0
29/08/2006
Ethics approval number [2] 5071 0
06/150

Summary
Brief summary
The aim of this trial is to estimate the difference in pain associated with the wearing or removal of suction or non-suction drains following gynaecological laparoscopic surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28382 0
Address 28382 0
Country 28382 0
Phone 28382 0
Fax 28382 0
Email 28382 0
Contact person for public queries
Name 11539 0
Dr Jason Abbott
Address 11539 0
Royal Hospital for Women
Barker St, Randwick, NSW
Australia, 2031
Country 11539 0
Australia
Phone 11539 0
02 93826733
Fax 11539 0
Email 11539 0
[email protected]
Contact person for scientific queries
Name 2467 0
Dr Jason Abbott
Address 2467 0
Royal Hospital for Women
Barker St, Randwick, NSW
Australia, 2031
Country 2467 0
Australia
Phone 2467 0
02 93826733
Fax 2467 0
Email 2467 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Of those who completed the study and who responded... [More Details]

Documents added automatically
No additional documents have been identified.