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NCT05805436 · ClinicalTrials.gov registry record · Phase 4
Preop Laxatives in Robotic Urologic Surgery
A Phase 4 study of Prostate Cancer and Kidney Cancer, sponsored by Chad R. Tracy.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 240
- Enrollment target
- 1
- Study location
NCT05805436 is a Phase 4 study of Prostate Cancer and Kidney Cancer that is actively recruiting participants, run by Chad R. Tracy. The registered enrollment target is 240 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05805436, a Phase 4 study of Prostate Cancer and Kidney Cancer, is actively recruiting participants, sponsored by Chad R. Tracy.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 240 participants
- Enrollment target
- 1
- Study location
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.
Conditions Studied
Interventions
- DRUG Polyethylene Glycol 3350
Study Locations (1)
Iowa
- University of Iowa Hospitals & Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2023-06-01 |
| Est. Completion | 2026-03-03 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05805436
The ClinicalTrials.gov registry entry for NCT05805436 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (61% lower). The listed sponsor is Chad R. Tracy, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Polyethylene Glycol 3350 is the first listed.
NCT05805436 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT05805436 about?
NCT05805436 is a clinical study titled "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 f...
What is the current status of trial NCT05805436?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 240 participants. The study started on 2023-06-01. Estimated completion is 2026-03-03.
What conditions does trial NCT05805436 study?
This clinical trial studies the following conditions: Prostate Cancer, Kidney Cancer, Constipation.
What interventions are being tested in trial NCT05805436?
The interventions under investigation include: Polyethylene Glycol 3350 (DRUG).
Who is sponsoring clinical trial NCT05805436?
This trial is sponsored by Chad R. Tracy, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05805436 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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