Polyethylene Glycol 3350 for Postoperative Bowel Function

Overseen By Kyrstin Warnimont, Master of Science

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Chicago

Must not be taking: Laxatives, Enemas, Suppositories

Disqualifiers: CKD, IDDM, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

101 Participants Needed

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.

Will 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.

What 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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 4 6}

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. ^{1 2 4 7 8}

Research Team

Diane Glass, MD, PhD

Principal Investigator

University of Chicago

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

Able to understand the consenting process and willing to participate in study

Exclusion Criteria

I have a colostomy.

You have insulin-dependent diabetes mellitus (IDDM).

I need surgery urgently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants in the intervention arm receive a 10-day preoperative bowel regimen with polyethylene glycol (PEG) daily

10 days

1 visit (in-person) for baseline assessment

Surgery and Immediate Postoperative

Participants undergo minimally invasive hysterectomy and complete a 7-day postoperative diary recording bowel movements and pain levels

7 days

1 visit (in-person) for surgery

Follow-up

Participants complete follow-up questionnaires to assess bowel function and quality of life

1 week

1 visit (virtual or in-person) for follow-up assessment

Treatment Details

Interventions

• Polyethylene Glycol 3350

Trial Overview 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.

Participant Groups

Group I: Participants receiving pre-operative laxative Experimental Treatment 1 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 laxative Active Control 1 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

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

Polyethylene glycol 3350 (MiraLAX) is an effective and safe osmotic laxative for treating chronic constipation in both children and adults, supported by 21 clinical studies involving 1949 patients.

The American College of Gastroenterology has given polyethylene glycol 3350 a grade A recommendation for its ability to improve stool frequency and consistency, indicating strong clinical support for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Over-the-counter laxative polyethylene glycol 3350: an evidence-based appraisal. Zurad, EG., Johanson, JF.[2019]

In a study of 304 patients with chronic constipation, PEG 3350 (MiraLAX) was found to be significantly more effective than placebo, with 52% of PEG users achieving treatment success compared to only 11% of those on placebo (P < 0.001).

The study demonstrated that PEG laxative is safe for long-term use, as there were no significant differences in adverse events or laboratory findings compared to placebo, although some gastrointestinal side effects like diarrhea and nausea were reported more frequently with PEG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. Dipalma, JA., Cleveland, MV., McGowan, J., et al.[2022]

In a study involving 23 patients with constipation, daily treatment with 17 g of polyethylene glycol (PEG) laxative significantly increased bowel movement frequency to once per day compared to a placebo, which resulted in about one bowel movement every two days.

The PEG treatment not only improved bowel movement frequency but also enhanced patients' subjective symptoms related to constipation, with no significant adverse effects observed in blood chemistry or other health markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New polyethylene glycol laxative for treatment of constipation in adults: a randomized, double-blind, placebo-controlled study. Cleveland, MV., Flavin, DP., Ruben, RA., et al.[2018]

In a study involving 311 patients, including 117 elderly individuals, polyethylene glycol 3350 (MiraLAX) was found to be safe and effective for treating chronic constipation over a 12-month period, with 80-88% of patients reporting successful treatment outcomes.

The treatment was associated with mild to moderate gastrointestinal side effects, such as diarrhea and nausea, but there were no significant changes in blood chemistry or hematology, indicating a favorable safety profile for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open-label study of chronic polyethylene glycol laxative use in chronic constipation. Di Palma, JA., Cleveland, MV., McGowan, J., et al.[2018]

In a study of 150 patients undergoing colonoscopy, the split-dose PEG-AA regimen provided significantly better bowel preparation quality compared to the single-dose PEG-3350 combined with a sports drink and bisacodyl, as measured by the Boston Bowel Preparation Scale.

There was no difference in patient satisfaction or serum electrolyte changes between the two regimens, suggesting that PEG-3350 does not offer any benefits over PEG-AA for bowel preparation and should be reconsidered for this use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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®). Khan, MA., Patel, KB., Nooruddin, M., et al.[2020]

A 7-year-old child developed acute kidney injury and altered mental status after using generic PEG 3350, suggesting possible contamination with ethylene glycol, which can lead to serious health issues.

The child's condition improved after treatment, highlighting the importance of recognizing potential contamination in PEG 3350 products, especially when symptoms like metabolic acidosis and kidney injury occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol 3350 Crystal Nephropathy in Association With Glomerular Mesangial Immunoglobin A Deposition. Aly, R., Acharya, R., Zeng, X., et al.[2022]

In a study involving 115 patients with chronic constipation, polyethylene glycol (PEG) 3350 was found to be more effective than lactulose, resulting in a higher number of stools and less straining after four weeks.

PEG 3350 was better tolerated than lactulose, with fewer reports of flatus and no serious adverse events, indicating it is a safe option for treating chronic constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Attar, A., Lémann, M., Ferguson, A., et al.[2022]

In a study involving 156 patients with chronic constipation, PEG3350 plus electrolytes (PEG3350 + E) significantly increased the frequency of spontaneous bowel movements compared to placebo, demonstrating its efficacy in resolving constipation.

The long-term use of PEG3350 + E over 52 weeks was well tolerated, with only mild gastrointestinal side effects reported, indicating its safety for chronic use in managing constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyethylene glycol 3350 plus electrolytes for chronic constipation: a 2-week, randomized, double-blind, placebo-controlled study with a 52-week open-label extension. Nakajima, A., Shinbo, K., Oota, A., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Over-the-counter laxative polyethylene glycol 3350: an evidence-based appraisal. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

New polyethylene glycol laxative for treatment of constipation in adults: a randomized, double-blind, placebo-controlled study. [2018]

4. England pubmed.ncbi.nlm.nih.gov

An open-label study of chronic polyethylene glycol laxative use in chronic constipation. [2018]

5. Turkey pubmed.ncbi.nlm.nih.gov

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]

6. Canada pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol 3350 Crystal Nephropathy in Association With Glomerular Mesangial Immunoglobin A Deposition. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

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]