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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

Must not have

Presence of colostomy

Emergent surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 10 days pre-operation to 7 days post-operation

Awards & highlights

Drug Has Already Been Approved

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

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.

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.

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 below

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I am a woman over 18 planning to have a minimally invasive hysterectomy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a colostomy.

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I need surgery urgently.

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I have gastric ulcers.

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I am scheduled for surgery on my intestines.

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My kidney function is reduced (Creatinine > 1.2 mg/dL).

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I regularly use products like PEG 3350 or laxatives before surgery.

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I am experiencing symptoms of a blockage in my small intestine.

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I often feel nauseous or vomit.

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I have trouble swallowing or a narrowed esophagus.

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I am unable to give consent by myself.

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I am scheduled for an open abdominal surgery.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from 10 days pre-operation to 7 days post-operation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL) Score

Patient Assessment of Constipation Symptoms questionnaire (PAC-SYM) Score

Secondary study objectives

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 • NCT03060512

Flatulence

Nausea

Abdominal pain

Urinary tract infection

Abdominal pain upper

Diarrhoea

Vertigo

Gastroenteritis

Laceration

Vomiting

Abdominal distension

Back pain

100%

80%

60%

40%

20%

Study treatment Arm

PEG 3350

Movantik

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 12Eligibility criteria met