Preop Laxatives in Robotic Urologic Surgery

NCT ID: NCT05805436

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2026-03-03

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.

Conditions

Prostate Cancer; Kidney Cancer; Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Do not receive polyethylene glycol before surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Receive polyethylene glycol before surgery

Group Type: EXPERIMENTAL

Polyethylene Glycol 3350

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chad R. Tracy

OTHER

Sponsor Role: lead

Responsible Party

Chad R. Tracy

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chad Tracy, MD

Role: CONTACT

chad-tracy@uiowa.edu

+1 319 335 8056

Facility Contacts

Chad Tracy, MD

Role: primary

Other Identifiers

202209015

Identifier Type: -

Identifier Source: org_study_id