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Trial registered on ANZCTR


Registration number
ACTRN12617000489392
Ethics application status
Approved
Date submitted
14/03/2017
Date registered
4/04/2017
Date last updated
26/10/2018
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] 291445 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deep Infiltrating Endometriosis 302475 0
Condition category
Condition code
Surgery 302035 302035 0 0
Other surgery
Reproductive Health and Childbirth 302085 302085 0 0
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] 297488 0
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] 301458 0
Bowel function after surgery for Deep Infiltrating Endometriosis. This will be assessed with the ICIQ-B questionnaire.
Timepoint [1] 301458 0
Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery
Primary outcome [2] 301522 0
Bladder function after surgery for deep infiltrating endometriosis. This will be assessed with the ICIQ-FLUTS questionnaire.
Timepoint [2] 301522 0
Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery
Secondary outcome [1] 332919 0
Sexual function after surgery for deep infiltrating endometriosis. This will be assessed with the FSFI questionnaire.
Timepoint [1] 332919 0
Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery
Secondary outcome [2] 332920 0
Pain scores after surgery for deep infiltrating endometriosis. This will be assessed with a Visual Analogue Scale questionnaire.
Timepoint [2] 332920 0
Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery
Secondary outcome [3] 332921 0
Quality of life after surgery for deep infiltrating endometriosis. This will be assessed with EQ-5D-5L Health Questionnaire.
Timepoint [3] 332921 0
Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery
Secondary outcome [4] 333310 0
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] 333310 0
Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery
Secondary outcome [5] 333311 0
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] 333311 0
Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery
Secondary outcome [6] 333392 0
Sexual function among patients with BOWEL TREATED deep endometriosis who underwent shaving or resection. This will be assessed with the FSFI questionnaire.
Timepoint [6] 333392 0
Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery
Secondary outcome [7] 333393 0
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] 333393 0
Prior to surgery
6 weeks after surgery
6 months after surgery
12 months after surgery
Secondary outcome [8] 333395 0
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] 333395 0
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
Gender
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7668 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 7669 0
Frances Perry House - Parkville
Recruitment hospital [3] 7670 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 15587 0
3052 - Parkville
Recruitment postcode(s) [2] 15588 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 295912 0
Hospital
Name [1] 295912 0
The Royal Women's Hospital
Address [1] 295912 0
Gynaecology 2 unit, The Royal Women's Hospital, 20 Flemington Rd, VIC 3052
Country [1] 295912 0
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] 294786 0
None
Name [1] 294786 0
Address [1] 294786 0
Country [1] 294786 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297193 0
The Royal Women's Hospital
Ethics committee address [1] 297193 0
20 Flemington Rd
Parkville
VIC 3052
Ethics committee country [1] 297193 0
Australia
Date submitted for ethics approval [1] 297193 0
04/07/2016
Approval date [1] 297193 0
28/09/2016
Ethics approval number [1] 297193 0

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 73294 0
Dr Uri Dior
Address 73294 0
Gynaecology 2 unit
The Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3052
Country 73294 0
Australia
Phone 73294 0
+61383452000
Fax 73294 0
Email 73294 0
uri.dior@thewomens.org.au
Contact person for public queries
Name 73295 0
Dr Uri Dior
Address 73295 0
Gynaecology 2 unit
The Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3052
Country 73295 0
Australia
Phone 73295 0
+61383452000
Fax 73295 0
Email 73295 0
uri.dior@thewomens.org.au
Contact person for scientific queries
Name 73296 0
Dr Uri Dior
Address 73296 0
Gynaecology 2 unit
The Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3052
Country 73296 0
Australia
Phone 73296 0
+61383452000
Fax 73296 0
Email 73296 0
uri.dior@gmail.com

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 other documents available
Summary results
No Results