Preop Laxatives in Robotic Urologic Surgery

Trial Title: Preop Laxatives in Robotic Urologic Surgery

NCT ID: NCT05805436

Condition: Prostate Cancer
Kidney Cancer
Constipation

Conditions: Official terms:
Kidney Neoplasms
Constipation
Polyethylene glycol 3350

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Polyethylene Glycol 3350
Description: Patients in the intervention arm will take polyethylene glycol 3350 for three days before robotic urologic surgery. Patients in the control arm will not.
Arm group label: Intervention

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.

Criteria for 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

Gender: All

Minimum age: 30 Years

Maximum age: 100 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: University of Iowa Hospitals & Clinics

Address:
City: Iowa City
Zip: 52242
Country: United States

Status: Recruiting

Contact:
Last name: Chad Tracy, MD

Start date: June 1, 2023

Completion date: March 3, 2025

Lead sponsor:
Agency: Chad R. Tracy
Agency class: Other

Source: University of Iowa

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05805436