Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05805436

Preop Laxatives in Robotic Urologic Surgery

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.

Recruiting

Interested in participating?

Request Info

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyethylene glycol 3350

Drug

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 outcomes

  1. Time to first bowel movement after surgery

    Time frame: 7 days

    Time to first bowel movement after surgery

Secondary outcomes

  1. Narcotic usage

    Time frame: 7 days

    Morphine equivalents used by patients in the first 7 days postoperatively

  2. Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire

    Time frame: 7 days

    Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire scores 7 days postoperatively (scale 0 - 48, higher score indicates worse constipation)

Study contacts

Contact information is provided by the study sponsor or research team.

Chad Tracy, MD

CONTACT

[email protected]

+1 319 335 8056

Sponsors and collaborators

Lead sponsor

Chad R. Tracy

Other

Registry information

Official study title

The Use of Preoperative Osmotic Laxatives to Improve Recovery of Bowel Function After Robotic-assisted Urologic Surgery

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2023
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.