Bowel Function After Minimally Invasive Hysterectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bowel Function After Minimally Invasive Hysterectomy: A Randomized Controlled Trial

Conditions
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Constipation

Intervention / Treatment
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* Drug: Polyethylene Glycol 3350


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants receiving pre-operative laxative<br>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. | Drug: Polyethylene Glycol 3350<br>* Participants will take 1 17g pack per day for 10 days preceding surgery.<br>* Other names: Miralax;|
| No Intervention: Participants not receiving pre-operative laxative<br>Participants will not be given any laxatives. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Assessment of Constipation Symptoms questionnaire (PAC-SYM) Score | 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. | From 10 days pre-operation to 7 days post-operation | 
| Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL) Score | 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). | From 10 days pre-operation to 7 days post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale for Pain Management | Visual analog scale - The visual analog scale (VAS) is a measure of subjective pain intensity. It is a continuous scale comprised of a horizontal visual analog scale that is 100 mm in length. The subject will place a mark on the scale to indicate the intensity of her pain. 0 mm would be no pain, 100 mm would be the greatest imaginable pain. Any mark in between will be measured in mm to indicate degree of pain the subject is experiencing. | Day of surgery to 7 days after surgery | 
| Pain medication consumption tracking by participant | Type of pain medication consumption will be collected for up to 7 days post-surgery. | Day of surgery to 7 days after surgery | 
| Pain medication consumption tracking by participant | Dosages of pain medication consumption will be collected for up to 7 days post-surgery. | Day of surgery to 7 days after surgery | 
| Wexner/ Constipation Scoring System/1996 Cleveland clinic score (CCS)/ Agachan Score | Wexner a commonly used scoring system, is designed to assess the prevalence and severity of constipation. It is based on pathophysiological definition of constipation. The scoring system is based on eight variables (frequency of bowel movements; difficult or painful evacuation; completeness of evacuation; abdominal pain; time per attempt; type of assistance including laxatives; digitations or enemas; number of unsuccessful attempts at evacuation in a 24-h period and duration of constipation). The CSS consists of seven items that are scored using a five-point Likert scale that ranges from 0 (none of the time) to 4 (all of the time) and one item that is rated on a 0-2 scale. A total score can range from 0 (normal) to 30 (severe constipation). A cutoff score of 15 suggests constipation. | Prior to surgery |