Preop Laxatives in Robotic Urologic Surgery

Phase 4

Recruiting

• Conditions: Prostate Cancer; Kidney Cancer; Constipation
• Interventions: Drug: Polyethylene Glycol 3350

• Registration Number: NCT05805436
• Lead Sponsor: Chad R. Tracy

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-04-10
• Study Start: 2023-06-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-26
• Primary Completion: 2025-03-02
• Study Completion: 2025-03-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Polyethylene Glycol 3350	Receive polyethylene glycol before surgery

Primary Outcome Measures

Name	Time	Method
Time to first bowel movement after surgery	7 days	Time to first bowel movement after surgery

Secondary Outcome Measures

Name	Time	Method
Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire	7 days	Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire scores 7 days postoperatively (scale 0 - 48, higher score indicates worse constipation)
Narcotic usage	7 days	Morphine equivalents used by patients in the first 7 days postoperatively

Trial Locations

Locations (1)

University of Iowa Hospitals & Clinics; 🇺🇸 Iowa City, Iowa, United States