Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000330640
Ethics application status
Approved
Date submitted
10/03/2023
Date registered
29/03/2023
Date last updated
7/04/2024
Date data sharing statement initially provided
29/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Polyethylene Glycol in prevention of constipation in patients undergoing laparoscopic surgery for non-cancerous gynaecological reasons
Scientific title
The effect of Polyethylene Glycol on constipation after benign gynaecological laparoscopy: A randomized controlled trial
Secondary ID [1] 309157 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative Constipation
329280 0
Condition category
Condition code
Oral and Gastrointestinal 326228 326228 0 0
Normal oral and gastrointestinal development and function
Surgery 326229 326229 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention arm study participants will receive polyethylene glycol 3350 powder in the form of Osmolax®. Osmolax® is an easily accessible TGA-approved laxative available over-the-counter which is tasteless. It is composed of PEG (also known as macrogol) which is a large polymer with osmotic activity. Osmotic laxatives are non-absorbable agents which work by increasing the amount of water in the large bowel.

The International Non-proprietary Name is Macrogol, the TGA approved name is 'Macrogol 3350', trade name OsmoLax manufactured by Key Pharmaceuticals Pty Ltd. The medication is being used according to TGA approved indications.

Patients will receive 8 pre-measured aliquots consisting of 17g of Macrogol in a powder form. They will be instructed to mix one dose of Macrogol with 250mls of any liquid of their choice, commencing from the evening of surgery for a total of 7 days. There is an additional dose included to account for any accidental loss of a dose. This is equivalent to one dose of Macrogol and the lowest recommended starting dose.

Patients will be randomly allocated to intervention or control. Intervention adherence will be addressed by self-responses from participants in a survey at 1 week post intervention.
Intervention code [1] 325607 0
Treatment: Drugs
Comparator / control treatment
Poly-Joule is an unflavoured carbohydrate supplement based on maltodextrin which is used for energy supplementation and disease-related malnutrition. It is a tasteless powder to be mixed with liquid for oral consumption.

Patients will receive 8 pre-measured aliquots consisting of 17g of Poly-Joule in a powder form. They will be instructed to mix one dose with 250mls of any liquid of their choice, commencing from the evening of surgery for a total of 7 days. There is an additional dose included to account for any accidental loss of a dose.
Control group
Placebo

Outcomes
Primary outcome [1] 334100 0
Rate of post-operative constipation in the week following surgery, defined using a modified ROME IV criteria, as two or more of:
o Passage of first stool after the third post operative day from surgery
o Straining to pass stool
o Lumpy or hard stools (form 1 or 2 on Bristol form scale)
o Sensation of anorectal blockage
o Sensation of incomplete emptying
o Use of manual maneuvers to facilitate bowel motion
o The use of additional laxatives to facilitate bowel movements (excluding study drug)

This will be assessed by a questionnaire given online (or paper based if required) given to participants at 7 days following surgery. This questionnaire was created specifically for this study.
Timepoint [1] 334100 0
1 week following surgery
Secondary outcome [1] 419335 0
Rate of pre-operative constipation as per Rome IV criteria, assessed by a questionnaire given online (or paper based if required) given to participants at recruitment. This questionnaire was created specifically for this study.
Timepoint [1] 419335 0
At recruitment, prior to randomisation
Secondary outcome [2] 419336 0
Level of distress or bother caused by post-operative constipation - assessed by an online questionnaire (or paper based if required) given to participants at 7 days and 6 weeks after surgery. This questionnaire was created specifically for this study.
Timepoint [2] 419336 0
1 week and 6 weeks after surgery
Secondary outcome [3] 419337 0
Level of post operative pain on Numerical Rating Scale (NRS)
Timepoint [3] 419337 0
1 week and 6 weeks after surgery
Secondary outcome [4] 419339 0
Opiate use – pre/intra and post operatively (equivalent mg of morphine / oxycodone)
The pre and post-op use will be assessed as reported by participants using an online questionnaire (or paper based if required) given to patients at 7 days and 6 weeks after suergery. This questionnaire was created specifically for this study.

The intra-op and inpatient post-op use will be recorded by the research team or treating doctors via the hospital records.
Timepoint [4] 419339 0
1 week and 6 weeks after surgery
Secondary outcome [5] 419340 0
Additional laxative use post operatively assessed by an online questionnaire (or paper based if required) given to participants at 7 days and 6 weeks after surgery. This questionnaire was created specifically for this study.
Timepoint [5] 419340 0
1 week and 6 weeks after surgery
Secondary outcome [6] 419341 0
Time to first bowel motion assessed by an online questionnaire created specifically for this study (or paper based if required) given to participants at 7 days based on patient recall.
Timepoint [6] 419341 0
1 week following surgery
Secondary outcome [7] 419342 0
Unplanned presentations to medical practitioner due to constipation or diarrhoea - assessed by an online questionnaire created specifically for this study (or paper based if required) given to participants at 7 days and 6 weeks after surgery with self-reported data and patient recall.
Timepoint [7] 419342 0
1 week and 6 weeks after surgery
Secondary outcome [8] 419343 0
Rate of post-operative constipation persistent at 6 weeks follow up - assessed by an online questionnaire created specifically for this study (or paper based if required) given to participants at 6 weeks after surgery.

It will based on patient's bowel habits in the past 6 weeks since surgery and self-reported data and will be based on a modified ROME IV criteria, as two or more of:
o Straining to pass stool
o Lumpy or hard stools (form 1 or 2 on Bristol form scale)
o Sensation of anorectal blockage
o Sensation of incomplete emptying
o Use of manual maneuvers to facilitate bowel motion
o The use of additional laxatives to facilitate bowel movements (excluding study drug)
Timepoint [8] 419343 0
6 weeks after surgery
Secondary outcome [9] 419344 0
Adverse side effects – cramping/bloating, bothersome or persistent diarrhoea, other adverse effects from laxative use

This will be assessed by an online questionnaire created specifically for this study (or paper based if required) given to participants at 7 days and 6 weeks after surgery with self-reported data and patient recall.
Timepoint [9] 419344 0
1 week and 6 weeks after surgery

Eligibility
Key inclusion criteria
• Age 18 – 60 years old
• English speaking
• Planned elective laparoscopic surgery for benign gynaecological indications
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Unable to provide informed consent
• Non-English speaking
• Known chronic bowel conditions (such as inflammatory bowel disease, bowel malignancy (active or previously treated), previous bowel resection
• Planned bowel shaving or resection for rectal endometriosis
• Planned hysterectomy (due to a longer length of stay, and higher risk of post-operative constipation during admission when compared to other benign gynaecological laparoscopies. It is also common to routinely prescribe laxatives to these patients)
• Bowel preparation prior to surgery
• Renal insufficiency
• Type 1 or type 2 diabetes mellitus
• Allergy to previous laxatives
• Allergy to maltodextrin or polyethylene glycol 3350
• Galactosemia

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Both participants and investigators will be blinded to randomization. A randomisation list will be given to Pharmacy staff who will package the placebo and study drug in identical packaging and number treatments according to study numbers. Pharmacy staff will not be blinded to randomisation, though patients and the research team will be blinded. Participants will be represented by a study ID after recruitment with other information de-identified.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be via a non-stratified random allocation table which will be software generated with use of Stata (StataCorp version 17) and will be variable block randomiastion
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The rate of constipation at 1 week following benign gynaecological laparoscopy is 70%. Based on the clinician stakeholder survey, a reduction in post-operative constipation of 30% was deemed to be a clinically significant reduction to consider use of routine PEG after benign laparoscopy. Though there is minimal evidence as to the efficacy of PEG in prevention of post-operative constipation Ford’s meta-analysis demonstrated an absolute risk reduction of 33% for treatment of chronic idiopathic constipation.

To detect such a difference with 80% power and two-sided significance of 0.05, 43 patients are required in each arm. We estimate a 20% dropout rate so our goal is to enroll 110 patients. We anticipate this to take 12 months. This is based on examining a random 4 week period of surgeries performed by the recruiting unit, where an average of 8-10 patients were eligible each week. Assuming a 30% recruitment rate, it will take approximately 12 months to complete recruitment.

The primary outcome will be presented as proportions. Comparison between the 2 treatment arms will be undertaken using univariable logistic regression and will be presented as an Odds Ratio with 95% confidence interval at time points of 1 week post-operatively (primary outcome) and 6 weeks post-operatively. If potential confounders are identified that are significantly different between the two treatment arms, multivariate regression will be performed to adjust for this. Continuous measures will be presented as mean (standard deviation) or median (interquartile range) and will be compared using the independent samples t-test or Mann-Whitney U-test if not normally distributed.

Tests will be considered significant if p<0.05 or 95% confidence intervals do not cross 1. Data will be calculated using Stata (StataCorp, College Station, TX). Analysis will be on a modified intention-to-treat principle.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
15/06/2023
Date of last participant enrolment
Anticipated
26/04/2024
Actual
Date of last data collection
Anticipated
7/06/2024
Actual
Sample size
Target
110
Accrual to date
83
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24263 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 39790 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 313357 0
Charities/Societies/Foundations
Name [1] 313357 0
Australasian gynaecological Endoscopy & Surgery society
Country [1] 313357 0
Australia
Primary sponsor type
Hospital
Name
The Royal Women's Hospital
Address
20 Flemington road Parkville 3052 VIC
Country
Australia
Secondary sponsor category [1] 315106 0
Individual
Name [1] 315106 0
Avelyn Wong
Address [1] 315106 0
The Royal Women's Hospital - 20 Flemington road Parkville 3052 VIC
Country [1] 315106 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312579 0
Royal womens hospital RESEARCH AND HUMAN RESEARCH ETHICS COMMITTEES
Ethics committee address [1] 312579 0
Ethics committee country [1] 312579 0
Australia
Date submitted for ethics approval [1] 312579 0
03/01/2023
Approval date [1] 312579 0
06/03/2023
Ethics approval number [1] 312579 0
HREC/92556/RWH-23-01

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

Contacts
Principal investigator
Name 125162 0
Dr Avelyn Wong
Address 125162 0
Royal Women's Hospital, 20 Flemington road Parkville 3052 VIC
Country 125162 0
Australia
Phone 125162 0
+61 412787737
Fax 125162 0
Email 125162 0
[email protected]
Contact person for public queries
Name 125163 0
Avelyn Wong
Address 125163 0
Royal Women's Hospital, 20 Flemington road Parkville 3052 VIC
Country 125163 0
Australia
Phone 125163 0
+61383452000
Fax 125163 0
Email 125163 0
[email protected]
Contact person for scientific queries
Name 125164 0
Avelyn Wong
Address 125164 0
Royal Women's Hospital, 20 Flemington road Parkville 3052 VIC
Country 125164 0
Australia
Phone 125164 0
+61383452000
Fax 125164 0
Email 125164 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in the final article will be available after deidentification.
When will data be available (start and end dates)?
Immediately following publication and ending 5 years following article publication.
Available to whom?
Investigators whose proposed use of the data has been approved by an independent review committee.
Available for what types of analyses?
To achieve aims in the approved proposal or for individual participant data meta-analysis
How or where can data be obtained?
Proposals may be submitted up to 5 years after publication and directed to the principal investigator at [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18566Study protocol    385526-(Uploaded-10-03-2023-18-30-25)-Study-related document.docx
18567Informed consent form    385526-(Uploaded-18-03-2023-15-56-46)-Study-related document.docx
18568Ethical approval    385526-(Uploaded-10-03-2023-18-33-32)-Study-related document.doc



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.