Recruiting

Preop Laxatives

Sponsor:

Chad R. Tracy

Code:

NCT05805436

Conditions

Prostate Cancer

Kidney Cancer

Constipation

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

Interventions

Polyethylene Glycol 3350

Study Details

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.

Conditions

Prostate Cancer

Kidney Cancer

Constipation

Study ID

NCT05805436

Start date

Jun 1, 2023

Status verified date

May, 2025

Completion date

Mar 3, 2026

Anticipated

Primary completion date

Mar 2, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

Do not receive polyethylene glycol before surgery

experimental: Intervention

Receive polyethylene glycol before surgery

Interventions

Polyethylene 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.

Primary outcome measure

  • Time to first bowel movement after surgery [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Locations

University of Iowa Hospitals & Clinics

Recruiting

Iowa City, Iowa, United States, 52242

More Information

Sponsor

Chad R. Tracy

Last update posted

May 30, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Chad R. Tracy on 2025-05-30.