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Preoperative Laxatives for Urologic Surgery Recovery

Phase 4
Recruiting
Research Sponsored by Chad R. Tracy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients 30 years or older undergoing robotic-assisted laparoscopic radical prostatectomy, transperitoneal radical nephrectomy, or transperitoneal partial nephrectomy
Be older than 18 years old
Must not have
Patients with severe ulcerative colitis or Crohn's disease
Patients with intestinal diversions (colostomy, ileostomy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will look at whether taking a laxative pre-surgery can improve recovery time and reduce postoperative symptoms in urology patients.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While Polyethylene Glycol is generally well-tolerated, potential side effects can include bloating, gas, upset stomach, dizziness and increased thirst. However specific side effects related to this trial's dosage and timing may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 30 or older and will have robotic surgery for prostate or kidney cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe ulcerative colitis or Crohn's disease.
Select...
I have a colostomy or ileostomy.
Select...
I cannot take certain laxatives due to health reasons.
Select...
I have had radiation therapy in my abdomen or pelvis before.
Select...
I am under 30 years old.
Select...
I am having surgery to remove all or part of my kidney.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to first bowel movement after surgery
Secondary study objectives
Narcotic usage
Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire

Side effects data

From 2017 Phase 4 trial • 276 Patients • NCT03060512
3%
Flatulence
2%
Nausea
2%
Abdominal pain
1%
Urinary tract infection
1%
Abdominal pain upper
1%
Diarrhoea
1%
Vertigo
1%
Gastroenteritis
1%
Laceration
1%
Vomiting
1%
Abdominal distension
1%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
PEG 3350
Movantik

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Receive polyethylene glycol before surgery
Group II: ControlActive Control1 Intervention
Do not receive polyethylene glycol before surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polyethylene Glycol 3350
2023
Completed Phase 4
~510

Find a Location

Who is running the clinical trial?

Chad R. TracyLead Sponsor

Media Library

Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05805436 — Phase 4
Constipation Research Study Groups: Intervention, Control
Constipation Clinical Trial 2023: Intervention Highlights & Side Effects. Trial Name: NCT05805436 — Phase 4
Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05805436 — Phase 4
~34 spots leftby Mar 2025
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