NCT05805436 Preop Laxatives in Robotic Urologic Surgery
| NCT ID | NCT05805436 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chad R. Tracy |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2026-03-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 240 participants in total. It began in 2023-06-01 with a primary completion date of 2026-03-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05805436 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 100 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05805436 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05805436 currently recruiting?
Yes, NCT05805436 is actively recruiting participants. Contact the research team at chad-tracy@uiowa.edu for enrollment information.
Where is the NCT05805436 trial being conducted?
This trial is being conducted at Iowa City, United States.
Who is sponsoring the NCT05805436 clinical trial?
NCT05805436 is sponsored by Chad R. Tracy. The trial plans to enroll 240 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.