Clinical trial NCT05805436: Preop Laxatives in Robotic Urologic Surgery
Official title: The Use of Preoperative Osmotic Laxatives to Improve Recovery of Bowel Function After Robotic-assisted Urologic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Prostate Cancer
Kidney Cancer
Constipation
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 240
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to first bowel movement after surgery
timeFrame: 7 days
Secondary outcomes:
measure: Narcotic usage
timeFrame: 7 days
measure: Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire
timeFrame: 7 days
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
Study officials:
References: