Polyethylene Glycol 3350 for Postoperative Bowel Function
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Chicago
No Placebo Group
Prior Safety Data
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?Postoperative constipation affects up to a third of women undergoing minimally invasive (MIS) gynecologic surgery and is a major source of anxiety and discomfort. The average time to first bowel movement after gynecologic surgery is about 2 to 4 days and some factors responsible for this include anesthesia inhibitory effect on gastrointestinal motility, opioid pain medication use, chronic NSAID use and anatomic manipulation.
There are no established regimens to manage postoperative constipation after minimally invasive gynecologic surgery. Two studies evaluating the implementation of postoperative bowel regimen with polyethylene glycol (PEG) and with Senna and Docusate found no significant impact on postoperative bowel function. There have been no studies looking at the effect of preoperative bowel regimens on postoperative bowel function.
The purpose of this study is to evaluate postoperative bowel function after minimally invasive hysterectomy in women receiving a preoperative 10-day bowel regimen of PEG daily.
How is the drug Polyethylene Glycol 3350 unique for postoperative bowel function?
Polyethylene Glycol 3350 (PEG 3350) is unique because it is a non-absorbable, non-metabolized osmotic agent that draws water into the bowel to help relieve constipation, making it effective for short-term use in occasional constipation, which may be beneficial for postoperative bowel function.
13457Is Polyethylene Glycol 3350 safe for humans?
Polyethylene Glycol 3350, commonly known as MiraLAX, is generally considered safe for short-term use in treating constipation. However, there have been rare reports of kidney issues in children potentially linked to contamination, so it's important to use it as directed and consult a doctor if unusual symptoms occur.
23458What data supports the effectiveness of the drug Polyethylene Glycol 3350 for improving bowel function after surgery?
Polyethylene Glycol 3350 (MiraLAX) is shown to be effective for treating constipation, as it is approved for short-term use in occasional constipation and has been studied for chronic constipation, indicating its ability to improve bowel movements.
23456Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you regularly use PEG 3350, laxatives, enemas, or suppositories, you cannot participate in the trial.
Eligibility Criteria
This trial is for women aged 18 or older who are about to have minimally invasive hysterectomy surgery and can understand the consent process. It's not for those who regularly use laxatives, have swallowing difficulties, bowel obstructions, certain medical conditions like chronic kidney disease or insulin-dependent diabetes mellitus, or are having emergency surgery.Inclusion Criteria
I am a woman over 18 planning to have a minimally invasive hysterectomy.
Exclusion Criteria
I have a colostomy.
I need surgery urgently.
I have gastric ulcers.
I am scheduled for surgery on my intestines.
My kidney function is reduced (Creatinine > 1.2 mg/dL).
I regularly use products like PEG 3350 or laxatives before surgery.
I am experiencing symptoms of a blockage in my small intestine.
I often feel nauseous or vomit.
I have trouble swallowing or a narrowed esophagus.
I am unable to give consent by myself.
I am scheduled for an open abdominal surgery.
Participant Groups
The study tests if taking a bowel-cleaning agent called Polyethylene Glycol (PEG) 3350 daily for 10 days before surgery improves postoperative bowel function in women undergoing minimally invasive hysterectomy compared to no preoperative regimen.
2Treatment groups
Experimental Treatment
Active Control
Group I: Participants receiving pre-operative laxativeExperimental Treatment1 Intervention
Participants will receive 10 doses, 17g each, of polyethylene glycol 3350. They will be instructed to take 1 dose/packet each day for 10 days leading up to their surgery.
Group II: Participants not receiving pre-operative laxativeActive Control1 Intervention
Participants will not be given any laxatives.
Polyethylene Glycol 3350 is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as MiraLAX for:
- Constipation
- Bowel preparation for colonoscopy or surgery
🇨🇦 Approved in Canada as Polyethylene Glycol 3350 for:
- Constipation
- Bowel preparation for colonoscopy or surgery
🇪🇺 Approved in European Union as Macrogol 3350 for:
- Constipation
- Faecal impaction
- Bowel preparation for colonoscopy or surgery
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Chicago MedicineChicago, IL
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Who is running the clinical trial?
University of ChicagoLead Sponsor
References
Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. [2022]Polyethylene glycol (PEG) 3350 is a non-absorbable, non-metabolised osmotic agent used in lavage solutions for gut cleansing.
New polyethylene glycol laxative for treatment of constipation in adults: a randomized, double-blind, placebo-controlled study. [2018]This study evaluated the safety and effectiveness of a new polyethylene glycol (PEG) laxative (MiraLax, Braintree Laboratories Inc, Braintree, Mass) in 23 patients reporting a history of constipation.
An open-label study of chronic polyethylene glycol laxative use in chronic constipation. [2018]Polyethylene glycol 3350 (MiraLAX, Braintree Laboratories Inc., Braintree, MA, USA) is approved for the short-term treatment of occasional constipation.
A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. [2022]Polyethylene glycol (PEG) 3350 (MiraLAX) is currently approved for the short-term treatment of occasional constipation. This study was designed to compare the safety and efficacy of PEG laxative versus placebo over a 6-month treatment period in patients with chronic constipation.
Over-the-counter laxative polyethylene glycol 3350: an evidence-based appraisal. [2019]To explore the clinical dimensions of chronic constipation and the role played in its treatment by laxatives in general and by polyethylene glycol 3350 (MiraLAX * ) in particular. * MiraLAX is a registered trade name of Schering-Plough HealthCare Products, Inc., Memphis, TN, USA, a subsidiary of Merck & Co., Inc.
Polyethylene Glycol-3350 (Miralax®)+1.9-L sports drink (Gatorade®)+2 tablets of bisacodyl results in inferior bowel preparation for colonoscopy compared with Polyethylene Glycol-Ascorbic Acid (MoviPrep®). [2020]Polyethylene glycol (PEG)-3350, approved by Food and Drug Administration (FDA) only for constipation, combined with 1.9 L of sports drink (SD) (GatoradeR) and bisacodyl (B) is commonly used in outpatient practice for bowel preparation due to cited patient satisfaction and tolerability of this specific regimen. We aim to compare PEG-3350 (MiralaxR) with PEG-AA-based (MoviPrepR) in terms of efficacy, patient satisfaction, and the effects of these two regimen on serum electrolytes.
Polyethylene glycol 3350 plus electrolytes for chronic constipation: a 2-week, randomized, double-blind, placebo-controlled study with a 52-week open-label extension. [2020]Although polyethylene glycol 3350 plus electrolytes (PEG3350 + E) is the most widely used osmotic laxative in Europe, prospective data on its long-term (over 6 months) safety and efficacy are not available to date.
Polyethylene Glycol 3350 Crystal Nephropathy in Association With Glomerular Mesangial Immunoglobin A Deposition. [2022]Polyethylene glycol (PEG) 3350, an active ingredient of over-the-counter MiraLAX, is a commonly used laxative in children and is produced by polymerization of ethylene glycol (EG). Masked EG toxicity secondary to contamination of PEG 3350 could occur. We present a 7-year-old child with developmental delay who presented with altered mental status and acute kidney injury (AKI) following intake of generic PEG 3350 for few days prior to presentation. There was high anion gap metabolic acidosis, hypernatremia, elevated osmolar gap, lactic acidosis, and AKI. Urinalysis showed tubular proteinuria, microscopic hematuria, and calcium oxalate crystals. Prior urinalyses were normal without hematuria or proteinuria. Renal biopsy revealed evidence of mesangial dominant immunoglobulin A (IgA) and complement 3 (C3) deposits along with dense tubular deposition of calcium oxalate crystals. He subsequently developed worsening oliguric AKI and required hemodialysis (HD) for several sessions. The AKI resolved within 2 weeks and further HD was not required. Mental status improved in few days. Follow-up urinalyses showed resolution of microscopic hematuria and crystalluria. We hypothesized that the generic PEG 3350 most likely was contaminated with EG leading to the presentation. A high index of suspicion of contamination of PEG 3350 with EG is required in patients presenting with unexplained high anion gap metabolic acidosis, elevated osmolar gap, lactic acidosis, AKI, calcium oxalate crystalluria, and oxalate crystals on renal biopsy. Further studies are needed to determine whether there is an association between transient glomerular mesangial IgA deposition and crystal nephropathy.