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Preop Laxatives in Robotic Urologic Surgery

Primary Purpose

Prostate Cancer, Kidney Cancer, Constipation

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Polyethylene Glycol 3350
Sponsored by
Chad R. Tracy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

30 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Iowa Hospitals & ClinicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Do not receive polyethylene glycol before surgery

Receive polyethylene glycol before surgery

Outcomes

Primary Outcome Measures

Time to first bowel movement after surgery
Time to first bowel movement after surgery

Secondary Outcome Measures

Narcotic usage
Morphine equivalents used by patients in the first 7 days postoperatively
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)

Full Information

First Posted
March 3, 2023
Last Updated
May 3, 2023
Sponsor
Chad R. Tracy
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1. Study Identification

Unique Protocol Identification Number
NCT05805436
Brief Title
Preop Laxatives in Robotic Urologic Surgery
Official Title
The Use of Preoperative Osmotic Laxatives to Improve Recovery of Bowel Function After Robotic-assisted Urologic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
March 2, 2025 (Anticipated)
Study Completion Date
March 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chad R. Tracy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Kidney Cancer, Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Do not receive polyethylene glycol before surgery
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Receive polyethylene glycol before surgery
Intervention Type
Drug
Intervention Name(s)
Polyethylene Glycol 3350
Intervention 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.
Primary Outcome Measure Information:
Title
Time to first bowel movement after surgery
Description
Time to first bowel movement after surgery
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Narcotic usage
Description
Morphine equivalents used by patients in the first 7 days postoperatively
Time Frame
7 days
Title
Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire
Description
Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire scores 7 days postoperatively (scale 0 - 48, higher score indicates worse constipation)
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chad Tracy, MD
Phone
+1 319 335 8056
Email
chad-tracy@uiowa.edu
Facility Information:
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chad Tracy, MD

12. IPD Sharing Statement

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Preop Laxatives in Robotic Urologic Surgery

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