ANZCTR - Registration

Please note that the copy function is not enabled for this field.
If you wish to modify existing outcomes, please copy and paste the current outcome text into the Update field.

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

ACTRN12617000489392

Ethics application status

Approved

Date submitted

14/03/2017

Date registered

4/04/2017

Date last updated

18/05/2021

Date data sharing statement initially provided

26/10/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Bladder and Bowel Symptoms after Key-Hole Surgery in Patients Suffering from Deep Endometriosis

Scientific title

Impact on Bladder and Bowel Function after Laparoscopic Surgery for Deep Infiltrating Endometriosis: a Prospective Study

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Deep Infiltrating Endometriosis

Condition category

Condition code

Surgery

Other surgery

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Laproscopic surgery for Deep Infiltrating Endometriosis. This surgery includes excision of any endometriotic lesion across the pelvic side walls, uterine ligaments and ovaries.
A minority of those cases include surgical treatment of bowel disease. This can be done by shaving or by resection.
The duration of surgery for treatment of deep endometriosis without bowel involvement is 1.5-4 hours-depending on the severity of the disease.
Duration of surgeries including bowel shaving is 3-4 hours,
Duration of surgeries including bowel resection is 4-5 hours,

Surgeries performed will be part of the usual care and no changes to patient's care are made as part of this study

This study will compare pre and postoperative symptoms of patients who had surgery for treatment of Deep Infiltrating Endometriosis. Assessment of symptoms will be done by questionnaires that will be filled before and at three points of time after surgery (6 weeks, 6 months, 12 months).

Intervention code [1]

Not applicable

Comparator / control treatment

Primary outcome: Each patient will be the case and the control., The "control" is the patient function before surgery and the case is the same patient function after surgery.

Secondary outcome: Comparator/Control: Bowel shaving. Comparison between bowel shaving and bowel resection will be made for all study outcomes.

Control group

Active

Outcomes

Primary outcome [1]

Bowel function after surgery for Deep Infiltrating Endometriosis. This will be assessed with the ICIQ-B questionnaire.

Timepoint [1]

Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery

Primary outcome [2]

Bladder function after surgery for deep infiltrating endometriosis. This will be assessed with the ICIQ-FLUTS questionnaire.

Timepoint [2]

Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery

Secondary outcome [1]

Sexual function after surgery for deep infiltrating endometriosis. This will be assessed with the FSFI questionnaire.

Timepoint [1]

Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery

Secondary outcome [2]

Pain scores after surgery for deep infiltrating endometriosis. This will be assessed with a Visual Analogue Scale questionnaire.

Timepoint [2]

Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery

Secondary outcome [3]

Quality of life after surgery for deep infiltrating endometriosis. This will be assessed with EQ-5D-5L Health Questionnaire.

Timepoint [3]

Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery

Secondary outcome [4]

Bladder function among patients with BOWEL TREATED deep endometriosis who underwent shaving or resection. This will be assessed with the ICIQ-FLUTS questionnaire.

Timepoint [4]

Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery

Secondary outcome [5]

Bowel function among patients with BOWEL TREATED deep endometriosis who underwent shaving or resection. This will be assessed with the ICIQ-B questionnaire.

Timepoint [5]

Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery

Secondary outcome [6]

Sexual function among patients with BOWEL TREATED deep endometriosis who underwent shaving or resection. This will be assessed with the FSFI questionnaire.

Timepoint [6]

Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery

Secondary outcome [7]

Pain scores among patients with BOWEL TREATED deep endometriosis who underwent shaving or resection. This will be assessed with a Visual Analogue Scale questionnaire.

Timepoint [7]

Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery

Secondary outcome [8]

Quality of life among patients with BOWEL TREATED deep endometriosis who underwent shaving or resections. This will be assessed with EQ-5D-5L Health Questionnaire.

Timepoint [8]

Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery

Eligibility

Key inclusion criteria

Pre-surgery:
Age: 18-50
Pelvic pain and suspected pelvic endometriosis
Planned laparoscopy for investigation and treatment of pelvic pain
Patient agreement to participate in the study

Post-surgery:
Surgical evidence of deep infiltrating endometriosis
Surgical treatment of deep infiltrating endometriosis
Clear documentation of surgical findings in the operation report

Minimum age

18 Years

Maximum age

50 Years

Sex

Females

Can healthy volunteers participate?

No

Key exclusion criteria

* Presence of co-morbidities affecting bladder and bowel function.
* Women who do not consent.
* Non-English speakers.

Study design

Purpose

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Sample size calculations:

Primary outcome:
This is a cohort study. Power calculations were done as a prospective independent study comparing two proportions. Prior data indicate that pre-operative bladder dysfunction rate of patients with DIE is 7%. If the bladder dysfunction rate after surgery is 35%, we will need to study 32 patients (before and after surgery) to be able to reject the null hypothesis that the dysfunction rates for post and pre-operative subjects are equal with probability (power 0.8). The Type I error probability associated with this test of this null hypothesis is .05. We will use an uncorrected chi-squared statistic to evaluate this null hypothesis.

Secondary outcome :
As we are not aware of any previous study that has compared the effect of different surgical methods for bowel endometriosis on long term bladder and bowel function, this study is a pilot study in regards to this outcome.
To note, there is a study that reterospectively assessed functional outcomes associated with surgical management of deep rectovaginal endometriosis with rectal involvement. In this study, segmental resection was associated with increased stool frequency as compared to nodule excision (52% vs 19%). If in our study bowel dysfunction rate after surgery is 52% with resection and 19% with shaving, we will need to study 32 experimental subjects and 32 control subjects to be able to reject the null hypothesis that the dysfunction rates for both surgical methods are equal with probability (power 0.8). The Type I error probability associated with this test of this null hypothesis is .05.
Power calculations were done by Dr. Uri Dior. Dr. Uri Dior is a laparoscopic fellow at The Women’s and has completed a Masters in Public Health including courses in Epidemiology and Biostatistics.

All data will be entered on a secure Excel database that is password protected. At completion of the study analysis will involve comparing proportions using Chi squared tests and comparing continuous variable measures using t-test. If the data does not have a normal distribution then a non-parametric tests such as the Mann Whitney U test will be used. When needed, results would be adjusted to confounding variables by using linear or logistic regression, as appropriate. 95% confidence intervals will be reported throughout. Statistical analyses will be carried out using SPSS.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

20/10/2016

Date of last participant enrolment

Anticipated

30/01/2019

Actual

30/12/2018

Date of last data collection

Anticipated

30/01/2020

Actual

30/01/2020

Sample size

Target

170

Accrual to date

Final

208

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Royal Women's Hospital - Parkville

Recruitment hospital [2]

Frances Perry House - Parkville

Recruitment hospital [3]

Epworth Richmond - Richmond

Recruitment postcode(s) [1]

3052 - Parkville

Recruitment postcode(s) [2]

3121 - Richmond

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Royal Women's Hospital

Address [1]

Gynaecology 2 unit, The Royal Women's Hospital, 20 Flemington Rd, VIC 3052

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Uri Dior

Address

Gynaecology 2 unit, The Royal Women's Hospital

20 Flemington Rd, Parkville, Vic 3052

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Women's Hospital

Ethics committee address [1]

20 Flemington Rd
Parkville
VIC 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/07/2016

Approval date [1]

28/09/2016

Ethics approval number [1]

Summary

Brief summary

Endometriosis is the leading cause for pelvic pain in women and is also associated with infertility. Twenty percent of patients with endometriosis suffer from Deep Infiltrating Endometriosis (DIE), defined as solid endometriotic masses situated deep in the peritoneum. Laparoscopic surgery is a very common treatment for DIE, however, its implications on future pelvic organ function are not yet clear. The overall aim of our research is to investigate the influence of laparoscopic surgery for DIE on bowel, bladder and sexual function. We further aim to compare the effect of different surgical approaches on bowel and bladder function after bowel surgery for DIE. Our hypothesis is that extensive and radical surgery for DIE (such as bowel resection) will be found to be associated with long-term adverse bladder and bowel function and that less radical surgical approaches (such as bowel shaving) would be associated with lower rates of bladder and bowel dysfunction.
The Royal Women’s Hospital is one of the largest women’s health institutes in Australia and is a major referral center for patients with pelvic pain and endometriosis. Patients will be recruited in the outpatients clinic and through the private rooms of the investigators in Frances Perry House and Epworth Richmond. Questionnaires will be filled before and at three points of time after surgery (6 weeks, 6 months, 1 year).  Up to date, there is very scarce data regarding long term function after laparoscopic surgery for DIE and some of it is contradicting. This study intends to recruit a significant amount of patients in order to shed light on this question. The data collected in this study will allow us to better council patients before undergoing major surgery for DIE.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Uri Dior

Address

Gynaecology 2 unit
The Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3052

Country

Australia

Phone

+61383452000

Fax

Email

[email protected]

Contact person for public queries

Name

Uri Dior

Address

Gynaecology 2 unit
The Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3052

Country

Australia

Phone

+61383452000

Fax

Email

[email protected]

Contact person for scientific queries

Name

Uri Dior

Address

Gynaecology 2 unit
The Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3052

Country

Australia

Phone

+61383452000

Fax

Email

[email protected]

Data sharing statement

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

No

No/undecided IPD sharing reason/comment

This was not asked or allowed in our ethics application

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.