Preoperative Laxatives for Urologic Surgery Recovery

Overseen By Chad Tracy, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Chad R. Tracy

Must not be taking: Miralax

Disqualifiers: Under 30, Ulcerative colitis, Crohn's, 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: 1

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether taking a laxative, polyethylene glycol (PEG or MiraLAX), before certain urologic surgeries can speed up bowel recovery and ease post-surgery stomach issues like nausea and bloating. It targets individuals undergoing robotic-assisted surgeries for prostate or kidney conditions. Participants will either take the laxative before surgery or not, with everyone following the same bowel care routine afterward. Ideal candidates are those aged 30 or older scheduled for specific robotic kidney or prostate surgeries and not already using MiraLAX regularly. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you regularly take Miralax, you cannot participate in the trial.

What is the safety track record for polyethylene glycol 3350?

Research has shown that polyethylene glycol 3350 (PEG) is generally safe for people. One study with 311 participants, including 117 older adults, found PEG to be safe and effective. Another study demonstrated that using PEG daily for 24 weeks was both effective and safe for those with long-term constipation. These results suggest that PEG is well-tolerated, with no major safety concerns. The trial's late phase indicates that substantial safety information already supports its use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for aiding recovery from urologic surgery focus on pain management and infection prevention. However, using polyethylene glycol 3350 as a preoperative laxative is unique because it specifically targets bowel preparation, which can help in reducing post-surgical complications like constipation. Unlike traditional methods that may rely on dietary adjustments or oral stool softeners post-surgery, polyethylene glycol 3350 is administered before surgery, potentially leading to a smoother recovery process. Researchers are excited about this approach because it could streamline the recovery phase and enhance patient comfort, addressing a common yet often overlooked issue in surgical recovery.

What evidence suggests that preoperative laxatives could be effective for urologic surgery recovery?

This trial will compare the use of polyethylene glycol 3350 (PEG, also known as MiraLAX) with no intervention before urologic surgery. Studies have shown mixed results for PEG in aiding bowel function post-surgery. One study with 311 patients, including older adults, found PEG safe and effective for treating constipation. However, other research indicated that PEG did not significantly speed up the return of bowel movements after surgery compared to a placebo. In another study on recovery from female pelvic surgery, PEG did not noticeably reduce the time to the first bowel movement. Despite these mixed results, PEG is generally considered safe and may help some individuals with bowel issues. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for patients aged 30 or older who are scheduled for robotic-assisted surgery due to kidney tumors or prostate cancer. It's not suitable for those under 30, with conditions that make laxatives risky, who won't follow up post-surgery, are incarcerated, regularly take Miralax, have had certain other surgeries or radiation treatments, or severe inflammatory bowel diseases.

Inclusion Criteria

I am 30 or older and will have robotic surgery for prostate or kidney cancer.

Exclusion Criteria

I have severe ulcerative colitis or Crohn's disease.

I have a colostomy or ileostomy.

I cannot take certain laxatives due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Treatment

Participants receive polyethylene glycol (PEG) for three days before surgery

3 days

1 visit (in-person)

Postoperative Treatment

Participants follow a postoperative bowel regimen including scheduled PEG until first bowel movement

7 days

In-hospital stay

Follow-up

Participants are monitored for gastrointestinal symptoms and time to first bowel movement

7 days

Questionnaire and diary submission

What Are the Treatments Tested in This Trial?

Interventions

• Polyethylene Glycol 3350

Trial Overview The study tests if taking an osmotic laxative (Polyethylene Glycol) before surgery helps in quicker recovery of bowel function and reduces gastrointestinal issues after urologic procedures. Participants will be randomly assigned to either receive the laxative pre-surgery or not and will track their symptoms postoperatively.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Receive polyethylene glycol before surgery

Group II: Control Active Control 1 Intervention

Do not receive polyethylene glycol before surgery

Who Is Running the Clinical Trial?

Chad R. Tracy

Lead Sponsor

Trials

1

Recruited

240+

Published Research Related to This Trial

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 151 constipated but otherwise healthy outpatients, Braintree polyethylene glycol (PEG) laxative significantly increased bowel movement frequency compared to a placebo, with an average of 4.5 movements per week in the PEG group versus 2.7 in the placebo group by week 2.

The PEG laxative was found to be safe, with no significant differences in laboratory results or adverse effects between the treatment and placebo groups, indicating its suitability for short-term use in treating constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative. DiPalma, JA., DeRidder, PH., Orlando, RC., et al.[2022]

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]

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]

A 3-month study involving 96 constipated children aged 6 months to 3 years demonstrated that polyethylene glycol (PEG) 4000 is safe and well-tolerated, with no significant treatment-related changes in blood parameters compared to lactulose.

PEG 4000 showed greater improvements in stool consistency, appetite, and reduced need for additional laxatives compared to lactulose, indicating its efficacy in treating pediatric constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind randomized evaluation of clinical and biological tolerance of polyethylene glycol 4000 versus lactulose in constipated children. Dupont, C., Leluyer, B., Maamri, N., et al.[2022]

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]

Citations

1. withpower.com withpower.com/trial/phase-4-kidney-neoplasms-3-2023-fdfa9

Preoperative Laxatives for Urologic Surgery Recovery In a study involving 311 patients, including 117 elderly individuals, polyethylene glycol 3350 (MiraLAX) was found to be safe and effective for treating ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-01653

A Laxative (Polyethylene Glycol) to Improve Recovery of ... This phase IV clinical trial tests how well polyethylene glycol (PEG) (also known as MiraLAX) works in improving recovery of bowel function in patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3641652/

Randomized, Double-Blind, Placebo-Controlled Trial of ... Nearly 50% of patients with urinary urge symptoms treated with either placebo or PEG for 1 month had improvement in urinary symptoms. KUB did ...

4. empr.com empr.com/home/news/study-examines-laxative-efficacy-post-urogynecologic-surgery/

Study Examines Laxative Efficacy Post-Urogynecologic ... The researchers found that, compared with placebo, PEG3350 did not significantly reduce the time to first bowel movement (2.77 versus 2.92 days; ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27500338/

Polyethylene Glycol 3350 and Docusate Sodium ... Polyethylene glycol 3350 did not significantly reduce time to first bowel movement after surgery compared with placebo (2.77 days [interquartile range 1.86-3. ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02292459

Efficacy and Safety of Polyethylene Glycol 3350 (PEG ... The purpose of this study is to evaluate the complete resolution of constipation in participants taking PEG 3350 compared to those taking PEG 4000, based on ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9481403/

Polyethylene Glycol 3350 in the Treatment of Chronic ... Once-daily polyethylene glycol 3350 demonstrated substantial and sustained efficacy and safety over 24 weeks in patients with chronic idiopathic constipation.