Bowel Function After Minimally Invasive Hysterectomy
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| ClinicalTrials.gov Identifier: NCT04263896 |
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Recruitment Status :
Recruiting
First Posted : February 11, 2020
Last Update Posted : October 22, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Constipation | Drug: Polyethylene Glycol 3350 | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 101 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Bowel Function After Minimally Invasive Hysterectomy: A Randomized Controlled Trial |
| Actual Study Start Date : | August 28, 2019 |
| Estimated Primary Completion Date : | June 30, 2022 |
| Estimated Study Completion Date : | June 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Drug: Polyethylene Glycol 3350
Participants will take 1 17g pack per day for 10 days preceding surgery.
Other Name: Miralax |
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No Intervention: Participants not receiving pre-operative laxative
Participants will not be given any laxatives.
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- Patient Assessment of Constipation Symptoms questionnaire (PAC-SYM) Score [ Time Frame: 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: 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).
- Visual Analog Scale for Pain Management [ Time Frame: Day of surgery to 7 days after surgery ]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 [ Time Frame: Day of surgery to 7 days after surgery ]Type of pain medication consumption will be collected for up to 7 days post-surgery.
- Pain medication consumption tracking by participant [ Time Frame: Day of surgery to 7 days after surgery ]Dosages of pain medication consumption will be collected for up to 7 days post-surgery.
- Wexner/ Constipation Scoring System/1996 Cleveland clinic score (CCS)/ Agachan Score [ Time Frame: Prior to 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | 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:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04263896
| Contact: Research Specialist 2 | 773-834-0171 | vdemart@uchicago.edu | |
| Contact: Dianne Glass, MD, PhD | 773-702-6118 | dianneglass@bsd.uchicago.edu |
| United States, Illinois | |
| University of Chicago Medicine | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Dianne Glass, MD, PhD 773-702-6118 dianneglass@bsd.uchicago.edu | |
| Principal Investigator: Dianne Glass, MD, PhD | |
| Principal Investigator: | Diane Glass, MD, PhD | University of Chicago |
Other Publications:
| Responsible Party: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT04263896 |
| Other Study ID Numbers: |
IRB19-0436 |
| First Posted: | February 11, 2020 Key Record Dates |
| Last Update Posted: | October 22, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Constipation Signs and Symptoms, Digestive Polyethylene glycol 3350 Laxatives Gastrointestinal Agents |