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RecruitingNCT05805436Updated May 30, 2025

Preop Laxatives in Robotic Urologic Surgery

A Phase 4 interventional study of Polyethylene Glycol 3350 in Prostate Cancer, Kidney Cancer and Constipation, sponsored by Chad R. Tracy. Recruiting at 1 site in United States. Open to participants aged 30 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-30.

Sponsored by Chad R. Tracy · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 4 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
30 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Prostate Cancer
  • Kidney Cancer
  • Constipation
03

In context

Kidney Neoplasms

956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

This study's planned enrollment of 240 is above the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.

Browse Kidney Neoplasms studies →

Lead sponsor

This is the only study on the registry with Chad R. Tracy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

-Patients 30 years or older undergoing robotic-assisted laparoscopic radical prostatectomy, transperitoneal radical nephrectomy, or transperitoneal partial nephrectomy

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
240 participants (estimated)

Study arms

  • No intervention
    Control

    Do not receive polyethylene glycol before surgery

  • Experimental
    Intervention

    Receive polyethylene glycol before surgery

    Drug: Polyethylene Glycol 3350

Interventions

  • DrugPolyethylene Glycol 3350

    Patients in the intervention arm will take polyethylene glycol 3350 for three days before robotic urologic surgery. Patients in the control arm will not.

06

What researchers measure

Primary outcomes

  1. Time to first bowel movement after surgery

    Time to first bowel movement after surgery

    Time frame: 7 days

Secondary outcomes

  1. Narcotic usage

    Morphine equivalents used by patients in the first 7 days postoperatively

    Time frame: 7 days

  2. 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)

    Time frame: 7 days

07

Study locations

1 of 1 sites recruiting
  • University of Iowa Hospitals & Clinics
    Iowa City, Iowa 52242, United States
    • Chad Tracy, MD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05805436
Lead sponsor
Chad R. Tracy
Responsible party
Chad R. Tracy (Clinical Professor, University of Iowa) — Sponsor-investigator
First posted
Apr 10, 2023
Start date
Jun 1, 2023
Primary completion
Mar 2, 2026 (estimated)
Completion
Mar 3, 2026 (estimated)
Last update
May 30, 2025

Study contacts

Chad Tracy, MD
Contact
chad-tracy@uiowa.edu
+1 319 335 8056

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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