Patient enrollment Prospective participants will be screened prior to their preoperative
appointment based on their presenting complaint (diagnosis) and the indicated surgical
procedure (foregut operations).
Patients will undergo informed consent by a member of the research team. Patients will
complete baseline survey (PROMIS Scale v1.1 - Gastrointestinal Gas and Bloating 13). This
is a paper survey that will be provided to them by a member of the research team.
Patient randomization Patients will be randomized into simethicone vs placebo groups via
unrestricted randomization The research pharmacist and DCI statistician will be the only
individuals who know if a patient is in the experimental (simethicone) group or the
control (placebo) group.
Patients will undergo their surgical procedure Postoperatively, all patients will be
ordered to receive either simethicone at 80mg or placebo prepared by research pharmacist
based on randomziation scheme four times per day. The research pharmacist will have the
appropriate patient randomization via MRN or FIN and will provide either simethicone or
placebo.
24 hours postoperatively, patients will recomplete the PROMIS Scale v1.1 -
Gastrointestinal Gas and Bloating 13a for comparison as well as complete the APS Patient
Outcome Questionnaire (APS-POQ-R) survey. Both of these are paper surveys that will be
provided to them.
If patients are admitted for greater than 1 night, they will complete the surveys every
24 hours until discharge. These are paper surveys that will be provided to them.
Patients will be discharged with simethicone for a total of a 14 day course (to include
their inpatient doses, 56 doses total) until their follow up appointment. Patients
assigned to the placebo group will receive placebo (56 doses). The total number of doses
any patient will receive, regardless of the length of their inpatient stay, is 56 doses.
This is the number of doses total for a 14 day course when taking the medication four
times per day.
At their standard postoperatively follow up visit, patients will re-complete their
(PROMIS Scale v1.1 - Gastrointestinal Gas and Bloating 13a). They will also complete a
compliance survey. These are both paper surveys that will be provided to them.
Data will be collected into master data sheet and data will then be de-identified with
pseudo-ID assigned according to the Master Key spreadsheet. The randomization spreadsheet
will only be accessed by the research pharmacist and the DCI statistician.
The master key will be kept under CAC-enabled protection The de-identified data will then
be collated and analyzed Data will then be reported and submitted for relevant
conferences The entirety of this project will take 4 years following IRB approval, 3
years for enrollment, perhaps an additional 1 year of data collection/analysis.
