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Trial registered on ANZCTR


Registration number
ACTRN12619001203145
Ethics application status
Approved
Date submitted
21/07/2019
Date registered
28/08/2019
Date last updated
1/02/2023
Date data sharing statement initially provided
28/08/2019
Date results information initially provided
1/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Constipation after elective laparoscopy for benign gyneacological indications – a prospective observational study
Scientific title
Constipation after elective laparoscopy for benign gyneacological indications – a prospective observational study
Secondary ID [1] 298797 0
nil
Universal Trial Number (UTN)
U1111-1237-3433
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
constipation
 313748 0
laparoscopy 313749 0
pain 313750 0
Condition category
Condition code
Renal and Urogenital 312153 312153 0 0
Other renal and urogenital disorders
Oral and Gastrointestinal 312505 312505 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients who are planned to undergo laparoscopy for treatment of a benign gynaecological indication will undergo three surveys. The surveys will occur prior to surgery, a week following surgery and three months following surgery. Each Survey will take approximately ten minutes to complete.

The first survey will include details of the patients demographic, past medical history, and indication for surgery. Then it will aim to define the patients normal bowel function prior to surgery

The second survey will define the patients post operative bowel habit. The distress or bother caused by the bowels. The use of laxative and opiates that may effect a patients bowel habit.

The third survey will review the patients bowel habits again to see if they have returned to normal function after surgery.
Intervention code [1] 315066 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320796 0
Our primary objective is to define the incidence of new onset constipation in patients undergoing elective laparoscopy. This primary outcome defined using the ROME IV definition of constipation

The primary outcome will be determined using a study-specific survey that is performed by the participant one week following surgery.

The incidence of post-operative constipation, based on a modified ROME IV criteria; Defined
as two or more of:
-Passage of first stool after the third post operative days from surgery
- Straining to pass stool
- Lumpy or hard stools (form 1 or 2 on Bristol stool form scale)
- Sensation of anorectal blockage
- Sensation of incomplete emptying
- Use of manual maneuvers to facilitate bowel motion
- Use of laxatives or enemas to facilitate bowel movements
Timepoint [1] 320796 0
one week following surgery
Secondary outcome [1] 372868 0
Level of distress or bother caused by post-operative constipation
This will be measured using a visual analogue scale between 0-10
Timepoint [1] 372868 0
one week and three months following surgery
Secondary outcome [2] 373643 0
Opiate use – pre/intra/ and post operatively
measured as per patient reporting and review of medication charts
Timepoint [2] 373643 0
Measured at one week post operatively
Secondary outcome [3] 373644 0
Laxative use – pre and post operatively
measured by patient self reporting
Timepoint [3] 373644 0
measured prior to surgery, one week post surgery, and three months post survery
Secondary outcome [4] 373645 0
Time to bowels return to normal pre-op status
This will be estimated by the participant as the time they felt bowels to return to normal (days or weeks). This assessed using a study specific survery at three months post surgery.
Timepoint [4] 373645 0
measured at three months postoperatively
Secondary outcome [5] 373646 0
Unplanned presentations to medical practitioner – Emergency department, general practitioner due to constipation
Measured as patient reporting presentations to emergency department
Timepoint [5] 373646 0
measured at one week and three months post operatively
Secondary outcome [6] 373647 0
Incidence of pre-operative constipation (functional or opiate induced constipation) as per Rome IV criteria

This will be assessed by a study specific survey using the ROME IV criteria that is completed by the participant prior to them undergoing surgery
Timepoint [6] 373647 0
measured prior to surgery
Secondary outcome [7] 373648 0
Incidence of post-operative constipation that is persistent at three months follow up (as per ROME IV criteria)

This will be assessed by a study specific survey using the ROME IV criteria that is completed by the participant three months after them undergoing surgery
Timepoint [7] 373648 0
measured at three months post operatively

Eligibility
Key inclusion criteria
Planned laparoscopic surgery for benign gyneacological indications
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Non consent
Non English speaking
Known chronic bowel conditions (such as inflammatory bowel disorders, bowel malignancy – active or previously treated, diverticular disease) with exception of IBS
Planned bowel shaving or bowel resection
Intra-operative bowel injury
Bowel preparation prior to surgery
Planned hysterectomy
Conversion to laparotomy

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
defined as % of people experiencing the event

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/09/2019
Actual
9/09/2019
Date of last participant enrolment
Anticipated
31/01/2020
Actual
31/03/2021
Date of last data collection
Anticipated
30/04/2020
Actual
30/06/2021
Sample size
Target
100
Accrual to date
Final
154
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14609 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 27630 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 303355 0
Hospital
Name [1] 303355 0
The Royal Womens Hospital
Country [1] 303355 0
Australia
Funding source category [2] 313093 0
Charities/Societies/Foundations
Name [2] 313093 0
the Australasian Gynaecological Endoscopic Society (AGES).
Country [2] 313093 0
Australia
Primary sponsor type
Hospital
Name
The Royal Women's Hospital
Address
22 flemington rd, Parkville. Victoria 3052
Country
Australia
Secondary sponsor category [1] 303385 0
None
Name [1] 303385 0
Address [1] 303385 0
Country [1] 303385 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303884 0
the royal women's hospital research and human research ethics committees
Ethics committee address [1] 303884 0
The Royal Women's Hospital
22 flemington rd, Parkville. Victoria, 3052
Ethics committee country [1] 303884 0
Australia
Date submitted for ethics approval [1] 303884 0
Approval date [1] 303884 0
11/07/2019
Ethics approval number [1] 303884 0
19/18

Summary
Brief summary
We aim to investigate the prevalence of constipation in patients undergoing elective laparoscopy for benign gynaecological indications. We also aim to investigate the negative impact that this has as well as factors that may predispose to this

This will be a prospective observation study. The participants will perform three surveys. Prior to surgery to assess baseline bowel function. One week post surgery to assess the immediate effect of surgery on bowel function. Three months after surgery to determine if symptoms are persistent or resolve
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 95122 0
Dr Paul Berlund
Address 95122 0
The Royal Women's Hospital
22 flemington rd, Parkville. Victoria, 3052
Country 95122 0
Australia
Phone 95122 0
+61 3 83452000
Fax 95122 0
Email 95122 0
[email protected]
Contact person for public queries
Name 95123 0
Paul Berlund
Address 95123 0
The Royal Women's Hospital
22 flemington rd, Parkville. Victoria, 3052
Country 95123 0
Australia
Phone 95123 0
+61 3 83452000
Fax 95123 0
Email 95123 0
[email protected]
Contact person for scientific queries
Name 95124 0
Paul Berlund
Address 95124 0
The Royal Women's Hospital
22 flemington rd, Parkville. Victoria, 3052
Country 95124 0
Australia
Phone 95124 0
+61 3 83452000
Fax 95124 0
Email 95124 0
[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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3303Study protocol    378016-(Uploaded-21-07-2019-14-57-51)-Study-related document.pdf
3304Ethical approval    378016-(Uploaded-27-08-2019-16-45-20)-Study-related document.doc
3306Informed consent form    378016-(Uploaded-21-07-2019-14-58-31)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 378016-(Uploaded-30-01-2023-15-12-52)-Basic results summary.docx
Plain language summaryNo Our study demonstrated that people who undergo lap... [More Details]

Documents added automatically
No additional documents have been identified.