RecruitingPhase 4ACTRN12623000330640

The effect of Polyethylene Glycol in prevention of constipation in patients undergoing laparoscopic surgery for non-cancerous gynaecological reasons

The effect of Polyethylene Glycol on constipation after benign gynaecological laparoscopy: A randomized controlled trial


Sponsor

The Royal Women's Hospital

Enrollment

110 participants

Start Date

Jun 15, 2023

Study Type

Interventional

Conditions

Summary

Constipation after surgery is common and causes bother for patients. This study aims to investigate whether the use of an over-the-counter laxative (scientific name Macrogol) helps to prevent constipation in patients undergoing a gynaecological laparoscopy for non-cancerous reasons. Participants will be given either the laxative or a placebo for 7 days. It is a double-blinded randomised controlled trial which means the participants and research team will not know which treatment has been assigned. Constipation rates and side effects will be assessed with patient questionnaires upon entering the study, and at 7 days and 6 weeks following surgery.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

Constipation after surgery is a very common and uncomfortable problem that affects many patients recovering from an operation. It can cause abdominal pain, bloating, and distress. This randomised controlled trial is investigating whether giving patients a commonly available, gentle laxative called Macrogol (polyethylene glycol) for 7 days after a laparoscopic (keyhole) gynaecological operation reduces the likelihood of constipation compared to a placebo. The study is focused on women having elective keyhole surgery for non-cancerous gynaecological conditions such as endometriosis, ovarian cysts, or fibroids. Participants are randomly assigned to take either the laxative powder or an identical-looking placebo powder dissolved in water, twice daily for 7 days after surgery. Questionnaires about bowel function and side effects are completed before surgery and at 7 days and 6 weeks after the operation. You may be eligible if you are a woman between 18 and 60 years old who is scheduled for elective laparoscopic gynaecological surgery for a benign (non-cancerous) reason, and speak English. Women with chronic bowel conditions such as inflammatory bowel disease, diabetes, kidney insufficiency, or planned bowel surgery as part of the procedure would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(1)

The Royal Women's Hospital - Parkville

VIC, Australia

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ACTRN12623000330640