Preop Laxatives in Robotic Urologic Surgery

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05805436
• Other study ID #: 202209015
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2023
• Est. completion date: March 3, 2025

Study information

• Verified date: December 2023
• Source: University of Iowa
• Contact: Chad Tracy, MD
• Phone: +1 319 335 8056
• Email: chad-tracy[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: March 3, 2025
• Est. primary completion date: March 2, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Kidney Cancer
• Kidney Neoplasms
• Prostate Cancer

Intervention

Drug:
• Polyethylene Glycol 3350
Patients in the intervention arm will take polyethylene glycol 3350 for three days before robotic urologic surgery. Patients in the control arm will not.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Chad R. Tracy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first bowel movement after surgery	Time to first bowel movement after surgery	7 days
Secondary	Narcotic usage	Morphine equivalents used by patients in the first 7 days postoperatively	7 days
Secondary	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