Preop Laxatives in Robotic Urologic Surgery

StatusRecruiting
PhasePhase 4
Started

Record status This record was last updated May 30, 2025 (before its estimated March 2, 2026 completion). Its status may not reflect the trial's current state.

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Record History

  1. Notable Primary completion date: Mar 2, 2025 to Mar 2, 2026
    • Study completion date: Mar 3, 2025 to Mar 3, 2026
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Notable Start date: Apr 15, 2023 to Jun 1, 2023v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT05805436
Lead Sponsor Chad R. Tracy
Conditions
(from sponsor)
Prostate Cancer, Kidney Cancer, Constipation
Related terms Constipation, Kidney Neoplasms, Prostatic Neoplasms
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov