Phase 4
N=97
Bowel Function After Minimally Invasive Hysterectomy
Constipation
Bottom Line
View on ClinicalTrials.gov: NCT04263896 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) Score — 1.1; 0.6 score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Polyethylene Glycol 3350 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Chicago
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) Score |
1.1; 0.6 | — |
| PRIMARY Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) Score |
8.4; 10; 21.6; 16.5 | — |
| SECONDARY Visual Analog Scale for Pain Management |
5.807692; 5.934615; 5.114815; 5.516; 4.572; 4.681481 | — |
| SECONDARY Pain Medication Consumption Tracking by Participant |
11.82692; 14.33333; 8.981481; 12.58333; 7.410714; 7.758621 | — |
| SECONDARY Wexner/ Constipation Scoring System/1996 Cleveland Clinic Score / Agachan Score |
7.3; 5.6 | — |
Summary
Postoperative constipation affects up to a third of women undergoing minimally invasive (MIS) gynecologic surgery and is a major source of anxiety and discomfort. The average time to first bowel movement after gynecologic surgery is about 2 to 4 days and some factors responsible for this include anesthesia inhibitory effect on gastrointestinal motility, opioid pain medication use, chronic nonsteroidal anti-inflammatory drugs (NSAID) use and anatomic manipulation.
There are no established regimens to manage postoperative constipation after minimally invasive gynecologic surgery. Two studies evaluating the implementation of postoperative bowel regimen with polyethylene glycol (PEG) and with Senna and Docusate found no significant impact on postoperative bowel function. There have been no studies looking at the effect of preoperative bowel regimens on postoperative bowel function.
The purpose of this study is to evaluate postoperative bowel function after minimally invasive hysterectomy in women receiving a preoperative 10-day bowel regimen of PEG daily.
Eligibility 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:
- Chronic Kidney Disease (Cr: > 1.2 mg/dL)
- Insulin-Dependent Diabetes Mellitus
- Cardiac disease
- Gastric ulcers
- Difficulty swallowing or esophageal stricture
- Persistent nausea or vomiting
- Signs or symptoms of a small bowel obstruction
Data sourced from ClinicalTrials.gov (NCT04263896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.