Clinical trial NCT04263896: Bowel Function After Minimally Invasive Hysterectomy
Official title: Bowel Function After Minimally Invasive Hysterectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Constipation
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Following enrollment subjects will be randomized into the intervention/treatment arm and control arm through a randomizing process in the investigator's database.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Assessment of Constipation Symptoms questionnaire (PAC-SYM) Score
timeFrame: From 10 days pre-operation to 7 days post-operation
measure: Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL) Score
timeFrame: From 10 days pre-operation to 7 days post-operation
Secondary outcomes:
measure: Visual Analog Scale for Pain Management
timeFrame: Day of surgery to 7 days after surgery
measure: Pain medication consumption tracking by participant
timeFrame: Day of surgery to 7 days after surgery
measure: Pain medication consumption tracking by participant
timeFrame: Day of surgery to 7 days after surgery
measure: Wexner/ Constipation Scoring System/1996 Cleveland clinic score (CCS)/ Agachan Score
timeFrame: Prior to surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
Study officials:
affiliation: University of Chicago
name: Diane Glass, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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