Preop Laxatives in Robotic Urologic Surgery

NCT05805436 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 202209015
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time to first bowel movement after surgery

  Time to first bowel movement after surgery

  7 days

Secondary Outcomes (2)

• Narcotic usage

  7 days

• Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire

  7 days

Study Arms (2)

Control

NO INTERVENTION

Do not receive polyethylene glycol before surgery

Intervention

EXPERIMENTAL

Receive polyethylene glycol before surgery

Drug: Polyethylene Glycol 3350

Interventions

Polyethylene Glycol 3350 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.

Intervention

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 30 years or older undergoing robotic-assisted laparoscopic radical prostatectomy, transperitoneal radical nephrectomy, or transperitoneal partial nephrectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Chad R. Tracy: lead

Study Sites (1)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Kidney Neoplasms; Constipation

Interventions

polyethylene glycol 3350

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chad Tracy, MD

CONTACT

+1 319 335 8056; chad-tracy@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: April 10, 2023
• Study Start: June 1, 2023
• Primary Completion: March 2, 2026
• Study Completion: March 3, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

US (1)