RECRUITING

Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery

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Conditions

ConstipationSurgical Procedure, UnspecifiedProlapse; Femalepostoperative constipationminimally invasive surgeryapical prolapseprolapse

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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

The goal of this clinical trial is to test the use of a laxative before surgery in women having surgery to fix pelvic prolapse that do not have constipation. The main question it aims to answer is: Does use of a laxative before surgery lessen the discomfort of bowel movements after surgery? Participants will be asked to complete questionnaires before and after surgery. Researchers will compare using the laxative before and after surgery versus only after surgery to see if there is less discomfort with bowel movements after surgery.

Official Title

Pre- and Post-operative Compared to Post-operative Only Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery

Quick Facts

Study Start:2024-06-05
Study Completion:2025-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06159777

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 to 89 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients assigned female sex at birth undergoing an apical prolapse procedure including: sacrocolpopexy, sacrospinous ligament suspension, uterosacral ligament suspension, or colpocleisis. Planned urogynecologic procedure may include hysterectomy, adnexectomy, colporrhaphy, perineorrhaphy, or treatment of stress urinary incontinence.
  2. * Planning to undergo primary procedure as above via minimally invasive route: vaginal or laparoscopic (including robotic-assisted). Including those that have an unplanned conversion intraoperatively of minimally invasive route to open laparotomy.
  1. * Diagnosis of irritable bowel syndrome, inflammatory bowel disease, slow transit constipation, obstructed defecation, or symptomatic constipation at time of study screening and recruitment. (Slow transit constipation and obstructed defecation defined as per American Gastroenterological Association 2013 constipation statement. Symptomatic constipation defined as any of the following: Bristol Stool Scale score of 1 or 2, PAC-SYM score greater than 1.0, self-reported 2 or less bowel movements per week.)
  2. * Current use of pharmacologic laxative agent ≥1x/week (prescription or OTC) for the treatment of constipation symptoms
  3. * Allergy or intolerance to polyethylene glycol 3350
  4. * Planning to undergo surgery via laparotomy
  5. * Scheduled for any concurrent non-urogynecologic procedure, ex abdominoplasty
  6. * History of large bowel resection, surgical treatment of constipation, or anal sphincter surgery
  7. * History of sacral neuromodulation
  8. * Current or prior radiation therapy to the abdomen or pelvis
  9. * Current or prior diagnosis of malignancy
  10. * Unable to provide informed consent

Contacts and Locations

Study Contact

Gabriella M Rustia, MD
CONTACT
216-202-0597
gabriella.rustia@uhhospitals.org

Principal Investigator

David Sheyn, MD
PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center

Study Locations (Sites)

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: University Hospitals Cleveland Medical Center

  • David Sheyn, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center

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 Date2024-06-05
Study Completion Date2025-02

Study Record Updates

Study Start Date2024-06-05
Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

  • postoperative constipation
  • minimally invasive surgery
  • apical prolapse
  • prolapse

Additional Relevant MeSH Terms

  • Constipation
  • Surgical Procedure, Unspecified
  • Prolapse; Female