ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

pelvic organ prolapse

learning surgical techniques

Condition category

Condition code

Surgery

Surgical techniques

Renal and Urogenital

Other renal and urogenital disorders

Public Health

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]

Not applicable

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

30 month fellowsip

Secondary outcome [1]

none

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4029 - Royal Brisbane Hospital

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Brisbane and Women's Hospital

Address [1]

Butterfield St & Bowen Bridge Rd, Herston QLD 4029

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and Women's Hospital

Ethics committee address [1]

Butterfield St & Bowen Bridge Rd, Herston QLD 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

06/03/2015

Ethics approval number [1]

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]

/AnzctrAttachments/372029-lap sacrocolpopexy HREC154.pdf (Ethics approval)

Contacts

Principal investigator

Name

Dr Alex Mowat

Address

Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029

Country

Australia

Phone

+61 404303334

Fax

zanhmowat@gmail.com

Contact person for public queries

Name

Alex Mowat

Address

Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029

Country

Australia

Phone

+61 404303334

Fax

zanhmowat@gmail.com

Contact person for scientific queries

Name

Dr Alex Mowat

Address

Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4029

Country

Australia

Phone

+61 404303334

Fax

zanhmowat@gmail.com

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically