Constipation
Conditions
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.
Interventions
DRUGPolyethylene Glycol 3350
Participants will take 1 17g pack per day for 10 days preceding surgery.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) Score | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale for Pain Management | The 7 days after surgery (surgery is D0) | 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. |
| Pain Medication Consumption Tracking by Participant | The 7 days after surgery (surgery is D0) | Dosages of pain medication consumption will be collected for up to 7 days post-surgery. |
| Wexner/ Constipation Scoring System/1996 Cleveland Clinic Score / Agachan Score | 7 days before surgery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| Participants Not Receiving Pre-operative Laxative Participants will not be given any pre-operative laxatives either through the study or through standard of care. | 28 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | converted to open procedure | 0 | 1 |
| Overall Study | excluded from analysis | 1 | 0 |
| Overall Study | Lost to Follow-up | 9 | 11 |
| Overall Study | surveys lost in mail | 5 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | Participants Not Receiving Pre-operative Laxative | Total | Participants Receiving Pre-operative Laxative |
|---|---|---|---|
| Age, Continuous | 48.1 year STANDARD_DEVIATION 10 | 46 year STANDARD_DEVIATION 10.4 | 44 year STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 55 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 18 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 19 Participants | 38 Participants | 19 Participants |
| Sex: Female, Male Female | 28 Participants | 61 Participants | 33 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 28 |
| other Total, other adverse events | 0 / 33 | 0 / 28 |
| serious Total, serious adverse events | 0 / 33 | 0 / 28 |
Outcome results
Primary
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).
Time frame: change in score from 10 days pre-operation to 7 days post-operation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Pre-operative Laxative | Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) Score | Satisfaction | 8.4 score | Standard Deviation 4.7 |
| Participants Receiving Pre-operative Laxative | Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) Score | Dissatisfaction | 21.6 score | Standard Deviation 19.7 |
| Participants Not Receiving Pre-operative Laxative | Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) Score | Satisfaction | 10 score | Standard Deviation 4.2 |
| Participants Not Receiving Pre-operative Laxative | Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) Score | Dissatisfaction | 16.5 score | Standard Deviation 14.9 |
Primary
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.
Time frame: change in score from 10 days pre-operation to 7 days post-operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Receiving Pre-operative Laxative | Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) Score | 1.1 score | Standard Deviation 0.7 |
| Participants Not Receiving Pre-operative Laxative | Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) Score | 0.6 score | Standard Deviation 0.6 |
Secondary
Pain Medication Consumption Tracking by Participant
Dosages of pain medication consumption will be collected for up to 7 days post-surgery.
Time frame: The 7 days after surgery (surgery is D0)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Pre-operative Laxative | Pain Medication Consumption Tracking by Participant | Day 3 | 7.410714 morphine milligram equivalents | Standard Deviation 9.824434 |
| Participants Receiving Pre-operative Laxative | Pain Medication Consumption Tracking by Participant | Day 5 | 2.222222 morphine milligram equivalents | Standard Deviation 5.814989 |
| Participants Receiving Pre-operative Laxative | Pain Medication Consumption Tracking by Participant | day 2 | 8.981481 morphine milligram equivalents | Standard Deviation 9.982178 |
| Participants Receiving Pre-operative Laxative | Pain Medication Consumption Tracking by Participant | Day 6 | 1.388889 morphine milligram equivalents | Standard Deviation 3.126602 |
| Participants Receiving Pre-operative Laxative | Pain Medication Consumption Tracking by Participant | Day 4 | 4.017857 morphine milligram equivalents | Standard Deviation 9.362536 |
| Participants Receiving Pre-operative Laxative | Pain Medication Consumption Tracking by Participant | Day 7 | 1.388889 morphine milligram equivalents | Standard Deviation 3.126602 |
| Participants Receiving Pre-operative Laxative | Pain Medication Consumption Tracking by Participant | day 1 | 11.82692 morphine milligram equivalents | Standard Deviation 8.903867 |
| Participants Not Receiving Pre-operative Laxative | Pain Medication Consumption Tracking by Participant | Day 7 | 0.483871 morphine milligram equivalents | Standard Deviation 1.981093 |
| Participants Not Receiving Pre-operative Laxative | Pain Medication Consumption Tracking by Participant | day 1 | 14.33333 morphine milligram equivalents | Standard Deviation 13.11312 |
| Participants Not Receiving Pre-operative Laxative | Pain Medication Consumption Tracking by Participant | day 2 | 12.58333 morphine milligram equivalents | Standard Deviation 15.51533 |
| Participants Not Receiving Pre-operative Laxative | Pain Medication Consumption Tracking by Participant | Day 3 | 7.758621 morphine milligram equivalents | Standard Deviation 12.0702 |
| Participants Not Receiving Pre-operative Laxative | Pain Medication Consumption Tracking by Participant | Day 4 | 5 morphine milligram equivalents | Standard Deviation 10.48809 |
| Participants Not Receiving Pre-operative Laxative | Pain Medication Consumption Tracking by Participant | Day 5 | 2.258065 morphine milligram equivalents | Standard Deviation 4.625781 |
| Participants Not Receiving Pre-operative Laxative | Pain Medication Consumption Tracking by Participant | Day 6 | 0.8333333 morphine milligram equivalents | Standard Deviation 2.653343 |
Secondary
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.
Time frame: The 7 days after surgery (surgery is D0)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Pre-operative Laxative | Visual Analog Scale for Pain Management | Day 6 | 3.494 score | Standard Deviation 2.386434 |
| Participants Receiving Pre-operative Laxative | Visual Analog Scale for Pain Management | Day 3 | 4.572 score | Standard Deviation 1.943691 |
| Participants Receiving Pre-operative Laxative | Visual Analog Scale for Pain Management | Day 1 | 5.807692 score | Standard Deviation 2.112235 |
| Participants Receiving Pre-operative Laxative | Visual Analog Scale for Pain Management | Day 5 | 3.580769 score | Standard Deviation 2.249092 |
| Participants Receiving Pre-operative Laxative | Visual Analog Scale for Pain Management | day 2 | 5.114815 score | Standard Deviation 1.886736 |
| Participants Receiving Pre-operative Laxative | Visual Analog Scale for Pain Management | Day 7 | 3.1044 score | Standard Deviation 2.345364 |
| Participants Receiving Pre-operative Laxative | Visual Analog Scale for Pain Management | Day 4 | 3.919231 score | Standard Deviation 2.234461 |
| Participants Not Receiving Pre-operative Laxative | Visual Analog Scale for Pain Management | Day 7 | 3.153846 score | Standard Deviation 2.423919 |
| Participants Not Receiving Pre-operative Laxative | Visual Analog Scale for Pain Management | Day 3 | 4.681481 score | Standard Deviation 2.068451 |
| Participants Not Receiving Pre-operative Laxative | Visual Analog Scale for Pain Management | Day 4 | 3.91 score | Standard Deviation 1.659694 |
| Participants Not Receiving Pre-operative Laxative | Visual Analog Scale for Pain Management | Day 5 | 3.902692 score | Standard Deviation 2.076619 |
| Participants Not Receiving Pre-operative Laxative | Visual Analog Scale for Pain Management | Day 6 | 3.193478 score | Standard Deviation 1.949843 |
| Participants Not Receiving Pre-operative Laxative | Visual Analog Scale for Pain Management | Day 1 | 5.934615 score | Standard Deviation 2.158507 |
| Participants Not Receiving Pre-operative Laxative | Visual Analog Scale for Pain Management | day 2 | 5.516 score | Standard Deviation 1.993517 |
Secondary
Wexner/ Constipation Scoring System/1996 Cleveland Clinic Score / 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.
Time frame: 7 days before surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Receiving Pre-operative Laxative | Wexner/ Constipation Scoring System/1996 Cleveland Clinic Score / Agachan Score | 7.3 score | Standard Deviation 5 |
| Participants Not Receiving Pre-operative Laxative | Wexner/ Constipation Scoring System/1996 Cleveland Clinic Score / Agachan Score | 5.6 score | Standard Deviation 3.7 |