Bowel Function After Minimally Invasive Hysterectomy

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    101
  • sponsor
    University of Chicago
Updated on 31 October 2021
analgesics
opioid
polyethylene glycol 3350
postoperative constipation
docusate
Accepts healthy volunteers

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 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.

Description

Following enrollment subjects will be randomized into the intervention/treatment arm and control arm. All subjects will be asked to complete a baseline demographic form and three questionnaires (PAC-SYM, PAC- QOL, Wexner Constipation score). Additional demographic information will be obtained from chart review. This information will include past medical history, use of constipating medications, use of daily pain medications, chronic pain history, use of daily fiber supplementation.

Subjects in the intervention arm will be given 10-day supply of Miralax and instructed on its use. They will take this medication for the 10 days prior to surgery. Subjects in the control arm will continue with standard care prior to surgery.

Post operatively, all subjects will complete a diary for 7 days. In this diary they will record details about their bowel movements (time of movement, discomfort, texture of stool). They will also report average daily pain levels ( with a visual analog scale), daily pain medication use (time, medication, total number of pills).

At the end of the 7th day all subjects will complete the same PAC questionnaires as they did pre-operatively.

Details
Condition Constipation
Treatment Polyethylene Glycol 3350
Clinical Study IdentifierNCT04263896
SponsorUniversity of Chicago
Last Modified on31 October 2021

Eligibility

Yes No Not Sure

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
CKD (Cr: > 1.2 mg/dL)
IDDM
Cardiac disease
Gastric ulcers
Difficulty swallowing or esophageal stricture
Persistent nausea or vomiting
Signs or symptoms of a small bowel obstruction
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note