Prostate CancerPhase 4NCT05805436
Preop Laxatives in Robotic Urologic Surgery
A Phase 4 study testing Polyethylene Glycol 3350 in people with Prostate Cancer and Kidney Cancer, run by Chad R. Tracy at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Kidney Cancer, Constipation
- What is being tested?
- Polyethylene Glycol 3350
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 3 Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Patients 30 years or older undergoing robotic-assisted laparoscopic radical prostatectomy, transperitoneal radical nephrectomy, or transperitoneal partial nephrectomy
Who cannot join
- 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)
Show all 9Show fewer
- Patients with prior abdominal or pelvic radiation
- Patients who will not follow up with UIHC postoperatively
- Patients who are incarcerated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Chad Tracy, MD
About this study
Official title: The Use of Preoperative Osmotic Laxatives to Improve Recovery of Bowel Function After Robotic-assisted Urologic Surgery
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.
- Conditions
- Prostate Cancer, Kidney Cancer, Constipation
- Being tested
- Polyethylene Glycol 3350
- Medical subject headings
- Prostatic Neoplasms, Kidney Neoplasms, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene Glycol 3350Drug
Patients in the intervention arm will take polyethylene glycol 3350 for three days before robotic urologic surgery. Patients in the control arm will not.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Do not receive polyethylene glycol before surgery |
| Intervention | Experimental | Receive polyethylene glycol before surgery Receives: Drug: Polyethylene Glycol 3350 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first bowel movement after surgery
Time to first bowel movement after surgery
Measured: 7 days
Secondary outcomes (2)
Narcotic usage
Morphine equivalents used by patients in the first 7 days postoperatively
Measured: 7 days
Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire
Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire scores 7 days postoperatively (scale 0 - 48, higher score indicates worse constipation)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Jun 2023
- Primary completion2 Mar 2026 (estimated)
- Study completion3 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chad R. Tracy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chad R. Tracy, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805436
- Sponsor's protocol ID
- 202209015
- Status last verified
- May 2025
- First submitted
- 3 Mar 2023
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Preoperative Osmotic Laxatives to Improve Recovery of Bowel Function After Robotic-assisted Urologic Surgery
- ClinicalTrials.gov ID
- NCT05805436
- Acronym / sponsor ID
- 202209015
- Conditions
- Prostate Cancer, Kidney Cancer, Constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Chad R. TracyUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 2 Mar 2026 (estimated)
- Study completion
- 3 Mar 2026 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Do not receive polyethylene glycol before surgery |
| Intervention | Experimental | Drug: Polyethylene Glycol 3350Receive polyethylene glycol before surgery |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients 30 years or older undergoing robotic-assisted laparoscopic radical prostatectomy, transperitoneal radical nephrectomy, or transperitoneal partial nephrectomy
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyethylene Glycol 3350Patients in the intervention arm will take polyethylene glycol 3350 for three days before robotic urologic surgery. Patients in the control arm will not. | Drug | Intervention |
Primary outcome
Time to first bowel movement after surgery
Time frame: 7 days
Time to first bowel movement after surgery
2 secondary outcomes
Narcotic usage
Time frame: 7 days
Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyethylene Glycol 3350 in people with Prostate Cancer and Kidney Cancer, run by Chad R. Tracy at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chad Tracy, MD (+1 319 335 8056, chad-tracy@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first bowel movement after surgery (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.