NCT05805436RecruitingPhase 4
Preop Laxatives in Robotic Urologic Surgery
The Use of Preoperative Osmotic Laxatives to Improve Recovery of Bowel Function After Robotic-assisted Urologic Surgery
Source: ClinicalTrials.gov · Last updated 30 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 3 Mar 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 2 Mar 2026
- Lead sponsor
- Chad R. Tracy
- Diseases
- Prostate cancer, Kidney cancer
- NCT number
- NCT05805436
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 240
- From 1 Jun 2023 to the primary completion date, 2 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a contraindication to receiving polyethylene glycol or other forms of laxatives
- Patients with prior abdominal or pelvic radiation
Other illness
- Patients with severe ulcerative colitis or Crohn's disease
Age
- Patients under 30 years old
Other
- People who regularly take Miralax
- Patients undergoing retroperitoneal radical or partial nephrectomy
- Patients with intestinal diversions (colostomy, ileostomy)
- Patients who will not follow up with UIHC postoperatively
- Patients who are incarcerated
Who the study is looking for
- -Patients 30 years or older undergoing robotic-assisted laparoscopic radical prostatectomy, transperitoneal radical nephrectomy, or transperitoneal partial nephrectomy
Age in the registry: 30 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Iowa Hospitals & Clinics Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.