No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
30 – 100
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
240 (estimated)
Sponsor
Chad R. Tracy · Other
Who this trial is looking for
This trial is looking for patients over 30 years old who are having robotic surgery for prostate or kidney cancer. Participants will take a laxative for three days before surgery and keep track of their recovery symptoms.
Are You a Good Fit for This Trial?
You may be able to join if
I am 30 years or older
I am undergoing robotic-assisted laparoscopic radical prostatectomy
I am undergoing transperitoneal radical nephrectomy
I am undergoing transperitoneal partial nephrectomy
You may not be able to join if
I am under 30 years old
I have a problem that prevents me from taking laxatives
I regularly take Miralax
I am undergoing retroperitoneal radical or partial nephrectomy
I have severe ulcerative colitis or Crohn's disease
I have had abdominal or pelvic radiation
I cannot follow up with UIHC after surgery
I am incarcerated
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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, an…
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.
Trial Locations
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Eligibility Criteria
Inclusion criteria:
-Patients 30 years or older undergoing robotic-assisted laparoscopic radical prostatectomy, transperitoneal radical nephrectomy, or transperitoneal partial nephrectomy
Exclusion criteria:
* Patients under 30 years old
* Patients with a contraindication to receiving polyethylen…
Inclusion criteria:
-Patients 30 years or older undergoing robotic-assisted laparoscopic radical prostatectomy, transperitoneal radical nephrectomy, or transperitoneal partial nephrectomy
Exclusion criteria:
* Patients under 30 years old
* Patients with a contraindication to receiving polyethylene glycol or other forms of laxatives
* People who regularly take Miralax
* Patients undergoing retroperitoneal radical or partial nephrectomy
* Patients with severe ulcerative colitis or Crohn's disease
* Patients with intestinal diversions (colostomy, ileostomy)
* Patients with prior abdominal or pelvic radiation
* Patients who will not follow up with UIHC postoperatively
* Patients who are incarcerated
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