Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000130369
Ethics application status
Approved
Date submitted
13/12/2016
Date registered
24/01/2017
Date last updated
24/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Learning curve for laparoscopic sacrocolpopexy within a structured learning programme.
Scientific title
Learning curve for lapraroscopic sacrocolpopexy for urogynaecology fellows within a structured learning programme.
Secondary ID [1] 290753 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pelvic organ prolapse 301343 0
learning surgical techniques 301364 0
Condition category
Condition code
Surgery 301094 301094 0 0
Surgical techniques
Renal and Urogenital 301095 301095 0 0
Other renal and urogenital disorders
Public Health 301117 301117 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Within a structured learning programme (laparoscopic suture practice, video editing, surgical assisting), the number or procedures (laparoscopic sacrocolpopexies (LSC)) needed for the Urogynaecology fellow to be deemed competent will be determined.
The structured learning programme comprises of assisting in 20 LSC, 2 hours of laparoscopic knot tying per week for 4 weeks and video editting 2 videos of mentor performing LSCs.
The duration of the fellowship is 30 months.
A group of four experts involved in the training and teaching of LSC agreed that an adequate level of skill would be attained after performance of five consecutive laparoscopic sacrocolpopexies without intra-operative complications (visceral injury, conversion to laparotomy or vaginal surgery, estimated blood loss over 500mls) or Clavien-Dindo grade III-IV post-operative complications and with an operative time of under 90 minutes. Time taken to perform the operation will be measured from peritoneal incision trocar placement until the peritoneum was closed over the mesh.
Intervention code [1] 296658 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300509 0
The number of procedures required for fellow to be deemed competent to perform laparoscopic sacrocolpopexies. Four experts deemed competence to be no intraoperative or clavien- dindo III or IV post-operative complications and operating time under 90 minutes.
Timepoint [1] 300509 0
30 month fellowsip
Secondary outcome [1] 330164 0
none
Timepoint [1] 330164 0
none

Eligibility
Key inclusion criteria
The study is assessing the learning curve of an individual fellow.
Patients who are consented for laparoscopic sacrocolpopexy (LSC) at the Royal Brisbane and Women's Hospital will be included.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
not consented for LSC

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used to analyse the data. For continuous data (eg operative time, estimated blood loss) means and standard deviations will be calculated and for categorical outcomes (eg complications) we will use frequency counts.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/03/2015
Date of last participant enrolment
Anticipated
1/08/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 14893 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 295179 0
Hospital
Name [1] 295179 0
Royal Brisbane and Women's Hospital
Country [1] 295179 0
Australia
Primary sponsor type
Individual
Name
Dr Alex Mowat
Address
Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 294008 0
None
Name [1] 294008 0
Address [1] 294008 0
Country [1] 294008 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296529 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 296529 0
Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Ethics committee country [1] 296529 0
Australia
Date submitted for ethics approval [1] 296529 0
Approval date [1] 296529 0
06/03/2015
Ethics approval number [1] 296529 0
HREC/15/QRBW/108

Summary
Brief summary
A laparoscopic sarcocolpopexy is an operation to treat recurrent vault prolpase in women with pelvic organ prolapse. It is a technically difficult operation to perform and is reported to have a long learning curve. (Claerhout F, Roovers JP, Lewi P, Verguts J, De Ridder D, Deprest J (2009) Implementation of laparoscopic sacrocolpopexy—a single centre’s experience. Int Urogynecol J Pelvic Floor Dysfunct 20(9):1119–1125.)
We designed a prospective study aimed at mapping the learning curve of laparoscopic sacrocolpopexy in the setting of a structured learning programme for a urogynaecology fellow at the Royal Brisbane and Women’s Hospital (RBWH).
The fellow had basic laparoscopic skills at the commencement of her fellow position and was required to assist in twenty laparoscopic sacrocolpopexies, video-edit two procedures and undertake laparoscopic suturing and knot tying training on a laparoscopic trainer for two hours per week for four weeks. After the completion of this structured learning programme, the fellow will begin performing LSC as the primary surgeon.
A group of four experts involved in the training and teaching of LSC agreed that an adequate level of skill would be attained after performance of five consecutive laparoscopic sacrocolpopexies without intra-operative complications (visceral injury, conversion to laparotomy or vaginal surgery, estimated blood loss over 500mls) or Clavien-Dindo grade III-IV post-operative complications and with an operative time of under 90 minutes. Time taken to perform the operation was measured from peritoneal incision trocar placement until the peritoneum was closed over the mesh.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1332 1332 0 0
/AnzctrAttachments/372029-lap sacrocolpopexy HREC154.pdf (Ethics approval)

Contacts
Principal investigator
Name 71174 0
Dr Alex Mowat
Address 71174 0
Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Country 71174 0
Australia
Phone 71174 0
+61 404303334
Fax 71174 0
Email 71174 0
[email protected]
Contact person for public queries
Name 71175 0
Alex Mowat
Address 71175 0
Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Country 71175 0
Australia
Phone 71175 0
+61 404303334
Fax 71175 0
Email 71175 0
[email protected]
Contact person for scientific queries
Name 71176 0
Dr Alex Mowat
Address 71176 0
Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Country 71176 0
Australia
Phone 71176 0
+61 404303334
Fax 71176 0
Email 71176 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.