Bowel Function After Minimally Invasive Hysterectomy: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Chicago
- Enrollment
- 97
- Locations
- 1
- Primary Endpoint
- Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) Score
Study Overview
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 nonsteroidal anti-inflammatory drugs (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 (Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Constipation Quality of Life (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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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:
- •Chronic Kidney Disease (Cr: > 1.2 mg/dL)
- •Insulin-Dependent Diabetes Mellitus
- •Cardiac disease
- •Gastric ulcers
- •Difficulty swallowing or esophageal stricture
- •Persistent nausea or vomiting
- •Signs or symptoms of a small bowel obstruction
Arms & Interventions
Participants receiving pre-operative laxative
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.
Intervention: Polyethylene Glycol 3350 (Drug)
Outcomes
Primary Outcomes
Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) Score
Time Frame: change in score from 10 days pre-operation to 7 days post-operation
Constipation will be evaluated both preoperatively and postoperatively using a validated questionnaires (PAC-SYM/PAC-QOL). Patient assessment of constipation symptoms (PAC-SYM) - The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire, developed through psychometric evaluation of adults with chronic constipation, is a tool for assessing the severity of patient-reported symptoms of this disorder. The 12-item questionnaire is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden.
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) Score
Time Frame: change in score from 10 days pre-operation to 7 days post-operation
Patient assessment of constipation quality of life (PAC-QOL) - PAC-Qol is a self-reported questionnaire, was used to measure the quality of life of patients.9 The validated PAC-QoL is composed of 28 items grouped into four subscales: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. The first three subscales are used to assess the patient dissatisfaction index, with an overall score ranging from 0 to 96 (where lower scores correspond to better quality of life). The satisfaction subscale includes four items with a global score ranging from 0 to 16, so that each patient's self-reported definitive outcome is defined as either poor (0-4), fairly good (5-8), good (9-12), or excellent (13-16).
Secondary Outcomes
- Visual Analog Scale for Pain Management(The 7 days after surgery (surgery is D0))
- Pain Medication Consumption Tracking by Participant(The 7 days after surgery (surgery is D0))
- Wexner/ Constipation Scoring System/1996 Cleveland Clinic Score / Agachan Score(7 days before surgery)