COMPLETED

Bowel Function After Minimally Invasive Hysterectomy

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Bowel Function After Minimally Invasive Hysterectomy: A Randomized Controlled Trial

Quick Facts

Study Start:2019-08-28
Study Completion:2025-06-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04263896

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Any woman ≥ 18 years of age undergoing a minimally invasive hysterectomy (Laparoscopic, robotic, vaginal)
  2. * Able to understand the consenting process and willing to participate in study
  1. * Planned laparotomy
  2. * Emergent surgery
  3. * Regular preoperative use of PEG 3350, laxatives, enemas or suppositories
  4. * Planned bowel surgery
  5. * Presence of colostomy
  6. * Inability to consent
  7. * Medical problems as follows:
  8. * Chronic Kidney Disease (Cr: \> 1.2 mg/dL)
  9. * Insulin-Dependent Diabetes Mellitus
  10. * Cardiac disease
  11. * Gastric ulcers
  12. * Difficulty swallowing or esophageal stricture
  13. * Persistent nausea or vomiting
  14. * Signs or symptoms of a small bowel obstruction

Contacts and Locations

Principal Investigator

Diane Glass, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

University of Chicago Medicine
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Diane Glass, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-28
Study Completion Date2025-06-09

Study Record Updates

Study Start Date2019-08-28
Study Completion Date2025-06-09

Terms related to this study

Additional Relevant MeSH Terms

  • Constipation