Preop Laxatives in Robotic Urologic Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer, Kidney Cancer, Constipation

Intervention / Treatment
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* Drug: Polyethylene Glycol 3350


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Do not receive polyethylene glycol before surgery | |
| Experimental: Intervention<br>Receive polyethylene glycol before surgery | Drug: Polyethylene Glycol 3350<br>* Patients in the intervention arm will take polyethylene glycol 3350 for three days before robotic urologic surgery. Patients in the control arm will not.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first bowel movement after surgery | Time to first bowel movement after surgery | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic usage | Morphine equivalents used by patients in the first 7 days postoperatively | 7 days | 
| Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire | Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire scores 7 days postoperatively (scale 0 - 48, higher score indicates worse constipation) | 7 days |