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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 30 or older and will have robotic surgery for prostate or kidney cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to first bowel movement after surgery
Secondary outcome measures
Narcotic usage
Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire
Side effects data
From 2017 Phase 4 trial • 276 Patients • NCT030605126%
Abdominal pain
4%
Diarrhoea
4%
Abdominal pain upper
3%
Flatulence
2%
Headache
1%
Bronchitis
1%
Drug withdrawal syndrome
1%
Dry mouth
1%
Defaecation urgency
1%
Cough
1%
Nausea
1%
Non-cardiac chest pain
1%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Movantik
PEG 3350
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
Eligibility Criteria:
This trial includes the following eligibility 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.I am 30 or older and will have robotic surgery for prostate or kidney cancer.I have had radiation therapy in my abdomen or pelvis before.I am under 30 years old.I regularly take Miralax.I am having surgery to remove all or part of my kidney.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent can Intervention be hazardous for individuals?
"There is ample evidence to suggest that Intervention has already been approved, so its safety rating was assessed as a 3."
Answered by AI
Are individuals aged 30 and over eligible to participate in this trial?
"Meeting the requirements for this trial, particpants must be between 30 and 100 years of age."
Answered by AI
What criteria must be met for a person to qualify for this research project?
"The prerequisites to join this clinical trial include having prostate cancer and an age between 30-100 years old. Currently, it is estimated that about 240 individuals will be able to participate in the study."
Answered by AI
Are there still opportunities for individuals to enroll in this clinical experiment?
"According to official research data hosted on clinicaltrials.gov, the trial is recruiting participants at this time. This study was initially posted on April 15th 2023 and underwent its most recent editing session on March 22nd of the same year."
Answered by AI
How many test subjects are currently enrolled in this clinical trial?
"Right, according to clinicaltrials.gov this trial is still open for enrollment and was initially posted on April 15th 2023 with a recent update taking place on March 22nd 2023. The study requires the recruitment of 240 patients at one medical facility."
Answered by AI
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