None listed
Conditions
Brief 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.
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 'Macr
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.
Sponsors
The Royal Women's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
• Age 18 – 60 years old • English speaking • Planned elective laparoscopic surgery for benign gynaecological indications
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
Outcome results
None listed