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Trial registered on ANZCTR


Registration number
ACTRN12612001273875
Ethics application status
Approved
Date submitted
6/12/2012
Date registered
10/12/2012
Date last updated
7/09/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study assessing the efficacy of the Capio device for sacrospinous ligament fixation.
Scientific title
A pilot study assessing the objective and subjective outcomes of the Capio device compared to published data on outcomes of the same surgery using the Miya Hook in women undergoing sacrospinous ligament fixation.
Secondary ID [1] 281627 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Apical vaginal prolapse 287911 0
Condition category
Condition code
Surgery 288288 288288 0 0
Surgical techniques
Renal and Urogenital 288297 288297 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Capio suturing device will be used to place the sacrospinous suture in the operation. The Capio suturing device is a single use instrument used to placed the sacrospinous suture. (The Miya Hook is a reusable instrument) Two sutures will be placed through the sacrospinous ligament and the apex of the vagina during each operation. The operation usually takes between 30 and 40minutes. There is some suggestion in the literature that the Capio device requires less tissue dissection than the Miya Hook and may therefore result in shorter operation and less blood loss.
Intervention code [1] 286159 0
Treatment: Devices
Comparator / control treatment
The outcomes of surgery will be compared to already published outcomes using the Miya Hook.
Using the outcome of no vaginal prolapse beyond halfway in the vagina, the objective success rate of sacrospinous colpopexy using the Miya Hook has been published as 67% and the subjective success rate, 94%( Maher CF, Murray CJ, Carey MP, Dwyer PL, Ugoni AM. Iliococcygeus or Sacrospinous Fixation for Vaginal Vault Prolapse. Obstet Gynecol 2001;98:40-4.)
Control group
Historical

Outcomes
Primary outcome [1] 288463 0
Objective success of surgery at 12 months with success defined as point C = halfway of total vaginal length.
(The POP-Q exam (particularly point C) will be undertaken intra-operatively (pre and post fixation) at 6 weeks post operatively and at 12 months post operatively)
Timepoint [1] 288463 0
Intraoperatively (pre- and post- fixation)
6 weeks postoperatively
12 months postoperatively
Secondary outcome [1] 300229 0
1.Objective success of surgery at 6 weeks post-operatively will be assessed clinically using the POP-Q examination
Timepoint [1] 300229 0
6 weeks
Secondary outcome [2] 300230 0
Subjective success of the surgery at 6 weeks and 12 months postoperatively
(ePAQ questionnaire (ePAQ Systems Ltd) will be completed by participants pre operatively, at 6 weeks post operatively and at 12 months post operatively)
Timepoint [2] 300230 0
6 weeks postoperatively
12 months postoperatively
Secondary outcome [3] 300231 0
operative time ( from when dissection to SSL commences until the time of fixation to the vaginal vault, therefore not including VH and/or repair times)
Timepoint [3] 300231 0
immediately post operation
Secondary outcome [4] 300232 0
estimated blood loss- this is an assessment made by the surgeon postoperatively- will include the amount of blood in the suction device as well as blood on sponges
Timepoint [4] 300232 0
immediately post operation
Secondary outcome [5] 300233 0
post operative right buttock pain- this will be assessed by a simple pain diary which each participant is required to fill out for 6 weeks postoepratively
Timepoint [5] 300233 0
6 weeks

Eligibility
Key inclusion criteria
Women consented to undergo a sacrospinous ligament fixation
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Unfit for surgery
Unable to fill in online questionnaires
Women preferring or electing to undergo abdominal or uterosacral vault suspension
Women undergoing mesh surgery
Women undergoing uterine preservation surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women will be invited to participate in the trial at routine outpatient appointments once they have been consented to under go the sacrospinous fixaiton operation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be used to analyse the data. For categorical outcomes (eg successful fixations) we will use frequency counts and for continuous data (eg operative time, estimated blood loss), means and standard deviations will be calculated. Where continuous data is not normally distributed, we will use medians and range for the analysis.
When we are analysis the pre and postoperative questionnaires a paired sample t test will be used to calculate differences in mean scores between the pre and postperative scores on the ePAQ questionnaire. Differences in categorical items will be calculated using the Chi squared statistic.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2013
Actual
Date of last participant enrolment
Anticipated
31/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 295 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [2] 296 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [3] 297 0
Nambour General Hospital - Nambour
Recruitment hospital [4] 298 0
Noosa Hospital - Noosaville
Recruitment hospital [5] 300 0
The Sunshine Coast Private Hospital - Buderim

Funding & Sponsors
Funding source category [1] 286435 0
Hospital
Name [1] 286435 0
Queen Elizabeth II Urogynaecology research fund
Country [1] 286435 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific
Address
Australia
Country
Australia
Secondary sponsor category [1] 285221 0
Commercial sector/Industry
Name [1] 285221 0
Boston Scientific
Address [1] 285221 0
Level 5, 247 Coward Street, Mascot NSW 2020
Country [1] 285221 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288513 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 288513 0
Ethics committee country [1] 288513 0
Australia
Date submitted for ethics approval [1] 288513 0
Approval date [1] 288513 0
14/11/2012
Ethics approval number [1] 288513 0
HREC/12/QRBW/339

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36414 0
Dr Alex Mowat
Address 36414 0
17 Illidge St
Coorparoo QLD 4151
Country 36414 0
Australia
Phone 36414 0
+61 7 36468111
Fax 36414 0
Email 36414 0
[email protected]
Contact person for public queries
Name 36415 0
Alex Mowat
Address 36415 0
17 Illidge St
Coorparoo QLD 4151
Country 36415 0
Australia
Phone 36415 0
+61 7 36468111
Fax 36415 0
Email 36415 0
[email protected]
Contact person for scientific queries
Name 36416 0
Alex Mowat
Address 36416 0
17 Illidge St
Coorparoo QLD 4151
Country 36416 0
Australia
Phone 36416 0
+61 7 36468111
Fax 36416 0
Email 36416 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.