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Laxative
Polyethylene Glycol 3350 for Postoperative Bowel Function
Phase 4
Recruiting
Led By Diane Glass, MD, PhD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Any woman ≥ 18 years of age undergoing a minimally invasive hysterectomy (Laparoscopic, robotic, vaginal)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 10 days pre-operation to 7 days post-operation
Awards & highlights
Study Summary
This trial will test whether a preoperative 10-day bowel regimen of PEG daily can improve postoperative bowel function after minimally invasive hysterectomy.
Who is the study for?
This trial is for women aged 18 or older who are about to have minimally invasive hysterectomy surgery and can understand the consent process. It's not for those who regularly use laxatives, have swallowing difficulties, bowel obstructions, certain medical conditions like chronic kidney disease or insulin-dependent diabetes mellitus, or are having emergency surgery.Check my eligibility
What is being tested?
The study tests if taking a bowel-cleaning agent called Polyethylene Glycol (PEG) 3350 daily for 10 days before surgery improves postoperative bowel function in women undergoing minimally invasive hysterectomy compared to no preoperative regimen.See study design
What are the potential side effects?
Polyethylene Glycol is generally well-tolerated but may cause side effects such as bloating, gas, upset stomach, dizziness or increased thirst. Severe allergic reactions are rare.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman over 18 planning to have a minimally invasive hysterectomy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 10 days pre-operation to 7 days post-operation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 10 days pre-operation to 7 days post-operation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL) Score
Patient Assessment of Constipation Symptoms questionnaire (PAC-SYM) Score
Secondary outcome measures
Pain medication consumption tracking by participant
Visual Analog Scale for Pain Management
Wexner/ Constipation Scoring System/1996 Cleveland clinic score (CCS)/ Agachan Score
Side effects data
From 2017 Phase 4 trial • 276 Patients • NCT030605126%
Abdominal pain
4%
Diarrhoea
4%
Abdominal pain upper
3%
Flatulence
2%
Headache
1%
Bronchitis
1%
Drug withdrawal syndrome
1%
Dry mouth
1%
Defaecation urgency
1%
Cough
1%
Nausea
1%
Non-cardiac chest pain
1%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Movantik
PEG 3350
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Participants receiving pre-operative laxativeExperimental Treatment1 Intervention
Participants will receive 10 doses, 17g each, of polyethylene glycol 3350. They will be instructed to take 1 dose/packet each day for 10 days leading up to their surgery.
Group II: Participants not receiving pre-operative laxativeActive Control1 Intervention
Participants will not be given any laxatives.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polyethylene glycol
FDA approved
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,690 Total Patients Enrolled
Diane Glass, MD, PhDPrincipal InvestigatorUniversity of Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a colostomy.You have insulin-dependent diabetes mellitus (IDDM).I need surgery urgently.I have a heart condition.I have gastric ulcers.I am scheduled for surgery on my intestines.My kidney function is reduced (Creatinine > 1.2 mg/dL).I regularly use products like PEG 3350 or laxatives before surgery.I am a woman over 18 planning to have a minimally invasive hysterectomy.I am experiencing symptoms of a blockage in my small intestine.I often feel nauseous or vomit.I have trouble swallowing or a narrowed esophagus.I am unable to give consent by myself.I am scheduled for an open abdominal surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Participants receiving pre-operative laxative
- Group 2: Participants not receiving pre-operative laxative
Awards:
This trial has 5 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Polyethylene Glycol 3350 for use?
"Polyethylene Glycol 3350 is a medically approved treatment, so it was rated a 3 on our team's safety scale."
Answered by AI
Are there additional investigations involving Polyethylene Glycol 3350?
"Currently, 16 different studies are in progress which investigate the effects of Polyethylene Glycol 3350. Of those inquiries, none have progressed to phase 3 yet. The primary hub for these trials is Tempe, Arizona; however there exist 25 sites around America where research is being conducted."
Answered by AI
Are there currently any openings for participation in this trial?
"Confirming the information present on clinicaltrials.gov, this medical trial is currently in search of patients to enroll. The study was initially published on August 28th 2019 and its details were most recently modified on October 20th 2021."
Answered by AI
What conditions can be alleviated by Polyethylene Glycol 3350?
"Polyethylene Glycol 3350 is an effective therapy for resolving dyschezia, colonoscopy, and constipation."
Answered by AI
How many participants are currently involved in this trial?
"Affirmative. Clinicaltrials.gov illustrates that this clinical research is actively seeking participants, initially posted on August 28th 2019 and recently updated October 20th 2021. The study requires 101 volunteers from a single site to be enrolled."
Answered by AI
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