Preop Laxatives in Robotic Urologic Surgery

Sponsor
Chad R. Tracy (Other)
Overall Status
Recruiting
CT.gov ID
NCT05805436
Collaborator
(none)
240
1
2
22.6
10.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Polyethylene Glycol 3350
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Use of Preoperative Osmotic Laxatives to Improve Recovery of Bowel Function After Robotic-assisted Urologic Surgery
Anticipated Study Start Date :
Apr 15, 2023
Anticipated Primary Completion Date :
Mar 2, 2025
Anticipated Study Completion Date :
Mar 3, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Do not receive polyethylene glycol before surgery

Experimental: Intervention

Receive polyethylene glycol before surgery

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.

Outcome Measures

Primary Outcome Measures

  1. Time to first bowel movement after surgery [7 days]

    Time to first bowel movement after surgery

Secondary Outcome Measures

  1. Narcotic usage [7 days]

    Morphine equivalents used by patients in the first 7 days postoperatively

  2. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Iowa Hospitals & Clinics Iowa City Iowa United States 52242

Sponsors and Collaborators

  • Chad R. Tracy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chad R. Tracy, Clinical Professor, University of Iowa
ClinicalTrials.gov Identifier:
NCT05805436
Other Study ID Numbers:
  • 202209015
First Posted:
Apr 10, 2023
Last Update Posted:
Apr 10, 2023
Last Verified:
Mar 1, 2023
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 10, 2023