Impact of Preoperative Miralax on Bowel Function After Hysterectomy
Bowel Function After Minimally Invasive Hysterectomy: A Randomized Controlled Trial
PHASE4 · University of Chicago · NCT04263896
This study tests whether taking Miralax for 10 days before a minimally invasive hysterectomy can help women have better bowel function and less discomfort after surgery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 101 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Chicago (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04263896 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of a preoperative regimen of Miralax on bowel function in women undergoing minimally invasive hysterectomy. Participants will be randomly assigned to either receive Miralax for 10 days before surgery or continue with standard care. They will complete questionnaires and maintain a diary to track bowel movements and pain levels post-surgery. The goal is to determine if preoperative use of Miralax can improve postoperative bowel function and reduce discomfort associated with constipation.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who are scheduled for a minimally invasive hysterectomy.
Not a fit: Patients who are undergoing laparotomy, have planned bowel surgery, or have certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative constipation and improve recovery experiences for women after minimally invasive hysterectomy.
How similar studies have performed: Previous studies have not shown significant impact from postoperative bowel regimens, making this approach novel in evaluating preoperative interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any woman ≥ 18 years of age undergoing a minimally invasive hysterectomy (Laparoscopic, robotic, vaginal) * Able to understand the consenting process and willing to participate in study Exclusion Criteria: * Planned laparotomy * Emergent surgery * Regular preoperative use of PEG 3350, laxatives, enemas or suppositories * Planned bowel surgery * Presence of colostomy * Inability to consent * Medical problems as follows: * CKD (Cr: \> 1.2 mg/dL) * IDDM * Cardiac disease * Gastric ulcers * Difficulty swallowing or esophageal stricture * Persistent nausea or vomiting * Signs or symptoms of a small bowel obstruction
Where this trial is running
Chicago, Illinois
- University of Chicago Medicine — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Principal investigator: Diane Glass, MD, PhD — University of Chicago
- Study coordinator: Kyrstin Warnimont, Master of Science
- Email: kwarnimont@bsd.uchicago.edu
- Phone: 6149379014
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Constipation