Preop Laxatives in Robotic Urologic Surgery

Clinicaltrials.gov ID: NCT05805436
db-list-check Status RECRUITING
b-loader Phase PHASE4
b-people Age 30 - 100 Years
b-bullseye-arrow Enrollments 240

Conditions

Prostate Cancer, Kidney Cancer, Constipation

Drugs

Polyethylene Glycol 3350

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Chad Tracy, MD

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

Study Plan

Control

NO_INTERVENTION

Do not receive polyethylene glycol before surgery

    Intervention

    EXPERIMENTAL

    Receive polyethylene glycol before surgery

    • DRUG:

      Polyethylene Glycol 3350

      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.

    Outcome Measures

    Primary Outcome Measures

    Time to first bowel movement after surgery

    Time Frame: 7 days

    Secondary Outcome Measures

    Narcotic usage

    Time Frame: 7 days

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

    Time Frame: 7 days

    Timeline

    • Last Updated
      December 26, 2023
    • Start Date
      April 10, 2023
    • Today
      May 9, 2025
    • Completion Date ( Estimated )
      March 3, 2025

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