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: Unknown

240 Participants Needed

Trial Summary

What is the purpose of this trial?

Minimally-invasive surgery, either laparoscopic or robotic, is commonly used in urology. Several urologic procedures including prostatectomy, radical nephrectomy, and partial nephrectomy are now commonly performed robotically. Patients undergoing these procedures often have delayed return of bowel function and persistent gastrointestinal symptoms including nausea/vomiting, abdominal distension, and bloating for several days to weeks after surgery. Postoperative stool softeners and laxatives are routinely used in an effort to minimize these symptoms, with varying degrees of success. The aim of this study will be to evaluate whether the use of a preoperative osmotic laxative will be beneficial in improving recovery of bowel function and alleviating postoperative gastrointestinal complaints in patients undergoing these procedures. Patients will be randomized to either receive or not receive three days of polyethylene glycol (PEG, also known as MiraLAX) on the three days before surgery. Patients in both groups will receive the same postoperative bowel regimen including scheduled PEG both in the hospital and upon discharge until first bowel movement. Patients will be given a questionnaire and diary to record their postoperative gastrointestinal symptoms and time to first bowel movement. These questionnaires and diaries will then be analyzed to determine differences in time to first bowel movement and gastrointestinal complaints during their recovery from surgery.

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 data supports the idea that Preoperative Laxatives for Urologic Surgery Recovery is an effective treatment?

The available research shows that polyethylene glycol 3350, commonly known as MiraLAX, is effective for treating constipation. Several studies have demonstrated its safety and effectiveness in relieving constipation symptoms. However, there is no specific data provided about its effectiveness for urologic surgery recovery compared to other treatments. The studies mainly focus on its use for constipation, not directly for surgery recovery. ^{1 2 3 4 5}

What safety data exists for preoperative laxatives like Polyethylene Glycol 3350?

Polyethylene Glycol 3350, commonly known as MiraLAX, is generally used for treating constipation. Safety data includes a case of potential contamination leading to kidney issues in a child, but this is not typical. Studies have evaluated its safety and effectiveness in adults and children, showing it is generally well-tolerated for short-term use. Further research is needed to explore rare adverse effects and contamination risks. ^{1 2 3 5 6}

Is the drug used in the trial 'Preoperative Laxatives for Urologic Surgery Recovery' a promising treatment?

Yes, the drug polyethylene glycol 3350, also known as MiraLAX, is a promising treatment because it is effective and safe for treating constipation, which can help in recovery after surgery. ^{1 2 3 4 5}

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+

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 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]

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 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]

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]

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]

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

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

3. Canada pubmed.ncbi.nlm.nih.gov

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

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

A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative. [2022]

5. England pubmed.ncbi.nlm.nih.gov

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

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

Double-blind randomized evaluation of clinical and biological tolerance of polyethylene glycol 4000 versus lactulose in constipated children. [2022]