Preop Laxatives in Robotic Urologic Surgery
Part of paid clinical trials in Iowa City, Iowa.
- Sponsor
- Chad R. Tracy
- Study ID
- NCT05805436
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Constipation
- Kidney Cancer
- Prostate Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 30 Years - 100 Years
- Healthy Volunteers
- Accepted
Interventions
- Polyethylene Glycol 3350 — DRUGPatients in the intervention arm will take polyethylene glycol 3350 for three days before robotic urologic surgery. Patients in the control arm will not.
Study Details
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.
Key Dates
- Start date
- Jun 1, 2023
- Status verified
- May 2025
- Primary completion
- Mar 2, 2026
- Completion
- Mar 3, 2026
Study Design
- Enrollment
- 240 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- No Intervention: ControlDo not receive polyethylene glycol before surgery
- Experimental: InterventionReceive polyethylene glycol before surgery
Primary Outcome Measure
Time to first bowel movement after surgery [ Time Frame: 7 days ]
Central Contacts
- Chad Tracy, MD+1 319 335 8056
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | Chad Tracy, MD |
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