Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000220460
Ethics application status
Approved
Date submitted
22/01/2025
Date registered
27/03/2025
Date last updated
27/03/2025
Date data sharing statement initially provided
27/03/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Endo Barostat Study: Determining the role of visceral hypersensitivity or chronic Intestinal inflammation in the generation of gastrointestinal symptoms in endometriosis
Scientific title
Determining the role of visceral hypersensitivity or chronic intestinal inflammation in the generation of gastrointestinal (GI) symptoms in patients with endometriosis: A Pilot Study.
Secondary ID [1] 312605 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Endo Barostat Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 334540 0
Irritable bowel syndrome 334541 0
Condition category
Condition code
Reproductive Health and Childbirth 331156 331156 0 0
Other reproductive health and childbirth disorders
Oral and Gastrointestinal 333271 333271 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study involves questionnaires, rectal barostat procedures and rectal biopsies.

Most participants would routinely receive rectal barostat procedures or rectal biopsies as part of their standard endometriosis care,

Initially participants will be required to complete a screening survey and/or have a conversation with the Study coordinator to determine their eligiblity to participate in this study.

If the screening survey or study coordinator determines they are eligible to participate in this study, they will have an initial screening appointment (via Zoom) with the study doctor (Dr Rebecca Burgell) who will confirm from a medical perspective they are suitable for the study and to provide the participant sufficient information about the study that they can complete an informed consent form (electronically at home, takes ~10 mins).

Consenting participants are then emailed a link to the study questionnaire and posted kits (and instructions) for collecting stool and vaginal samples. The questionnaire + stool and vaginal samples can be collected from home in the days preceding your appointment at the Alfred for the rectal barostat and biopsy procedure (described below). The questionnaire is a one-off cluster questionnaire that takes ~30 minutes to complete and asks questions about gastrointestinal symptoms, endometriosis, quality of life and mental health. The stool and vaginal samples take ~ 10 minutes to collect.

On the day of the barostat procedure, participants are required to fast overnight, then in the morning, attend the Gastrointestinal Physiology Laboratory at the Alfred Hospital to complete the rectal barostat procedure.

On arrival, participants are asked questions about their gastrointestinal symptoms and bowel habits. If required, they may be given a water enema to clean out the lower part of their bowel. Participants are then asked to lie on their side with their legs bent. After a brief rectal examination, a thin tube with a bag attached is eased gently into place inside the rectum.

First, the bag is inflated slowly with a little air and then deflated to ensure that it is lying correctly within the last part of the bowel.
The sensation of the bowel are then tested by a series tests where varying amount of air is put into the bag. Participants are given a keypad to register the sensations they feel. Participants are given a button they can press to terminate the procedure immediately.
Immediately following the barostat examination, 4 x rectal biopsies are taken. A rectal biopsy is a procedure involving the removal of a small amount (~ 1mm) of tissue from the rectum. To perform this procedure a telescope is passed across the anal canal and special forceps are used to take a tiny piece of the lining of the bowel. The tissue is sent to pathology for testing.

Possible complications - possible discomfort during the barostat procedure and rectal biopsies. Small risk of infection and bleeding (which very rarely can be significant) or damage to the rectal mucosa or bowel wall from a rectal biopsy, but this is considered extremely low, less than 1 in 10,000 patients experience this problem. If this did occur, there may be a need for surgery to repair the area. If an abnormality is found on either examination or on biopsy that could impact the participant's health, they will be contacted by the study team and follow up will be arranged through the Department of Gastroenterology at Alfred Health or an alternative clinician (depending on the participant's preference)

Total duration of involvement - 1-2 months, depending on when the barostat procedure is scheduled after the initial Zoom screening appt with the study gastroenterologist.
Intervention code [1] 329126 0
Diagnosis / Prognosis
Intervention code [2] 330618 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340459 0
Rectal sensitivity to mechanical distension
Timepoint [1] 340459 0
One-off assessment - observational data
Secondary outcome [1] 444159 0
Gastrointestinal symptoms
Timepoint [1] 444159 0
One-off assessment - observational data
Secondary outcome [2] 444160 0
Markers of intestinal inflammation (e.g. neutrophils and eosinophils)
Timepoint [2] 444160 0
One-off assessment - observational data
Secondary outcome [3] 444161 0
Microbiota profile
Timepoint [3] 444161 0
One-off assessment - observational data
Secondary outcome [4] 445219 0
Vaginal microbiota
Timepoint [4] 445219 0
One-off assessment - observational data

Eligibility
Key inclusion criteria
Female patients (aged between 18 and menopause) confirmed to have endometriosis via laparoscopy or on imaging studies.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Recent laparoscopic surgery (within last 3 months)
Coeliac disease and/or other gastrointestinal disease
Malnutrition
Irregular periods
Uncontrolled physical or mental illness
Inability to read or understand English

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/05/2023
Date of last participant enrolment
Anticipated
30/05/2025
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
15
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317034 0
Government body
Name [1] 317034 0
Australian Government Department of Health and Aged Care: Medical Research Future Fund
Country [1] 317034 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 319281 0
None
Name [1] 319281 0
Address [1] 319281 0
Country [1] 319281 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315790 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 315790 0
Ethics committee country [1] 315790 0
Australia
Date submitted for ethics approval [1] 315790 0
25/05/2022
Approval date [1] 315790 0
05/08/2022
Ethics approval number [1] 315790 0
33011

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

Contacts
Principal investigator
Name 135802 0
Dr Jane Varney
Address 135802 0
Monash University, Department of Gastroenterology, Level 6 99 Commercial Rd, Melbourne VIC 3004
Country 135802 0
Australia
Phone 135802 0
+61412944848
Fax 135802 0
Email 135802 0
[email protected]
Contact person for public queries
Name 135803 0
Jane Varney
Address 135803 0
Monash University, Department of Gastroenterology, Level 6 99 Commercial Rd, Melbourne VIC 3004
Country 135803 0
Australia
Phone 135803 0
+61412944848
Fax 135803 0
Email 135803 0
[email protected]
Contact person for scientific queries
Name 135804 0
Jane Varney
Address 135804 0
Monash University, Department of Gastroenterology, Level 6 99 Commercial Rd, Melbourne VIC 3004
Country 135804 0
Australia
Phone 135804 0
+61412944848
Fax 135804 0
Email 135804 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.