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NCT05805436 · ClinicalTrials.gov record · last posted 2025-05-30

Preop Laxatives in Robotic Urologic Surgery

StatusRecruiting
PhasePhase 4
Started2023-06-01
View on ClinicalTrials.gov ↗
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.
from the ClinicalTrials.gov record
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.

Amendment record 3 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 3 times since 2023-03-22; most recent amendment 2025-05-23. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

Trial Details
NCT Number NCT05805436
Lead Sponsor Chad R. Tracy
Conditions Prostate Cancer, Kidney Cancer, Constipation
Enrollment 240 participants
Start Date 2023-06-01
Primary Completion 2026-03-02 (estimated)
Study Completion 2026-03-03 (estimated)
Updated on ClinicalTrials.gov 2025-05-30