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
The Royal Women's Hospital
110 participants
Jun 15, 2023
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
Plain Language Summary
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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 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.
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ACTRN12623000330640