Bowel Function After Minimally Invasive Hysterectomy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Constipation
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 c...
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.
Tracking Information
- NCT #
- NCT04263896
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Diane Glass, MD, PhD University of Chicago