A Phase 4 interventional study of Simethicone 80 MG and Placebo in Simethicone, Bariatric Surgery and Post-operative Pain, sponsored by Madigan Army Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Madigan Army Medical Center · Phase 4, Interventional, and Treatment
By conducting this study, we hope to assess if simethicone (also known as Gas Relief or GasX) has an effect on improving gas pain and bloating specifically in patients undergoing foregut procedures to include bariatric procedures (sleeve gastrectomy, Roux-en-Y gastric bypass), hiatal hernia, and gastric surgery.
The purpose of this research is to gather information on the safety and effectiveness of simethicone. Simethicone (more commonly known as Gas Relief or Gas-X) relieves pressure, bloating, and fullness commonly referred to as gas. It is FDA approved. The use of this medication in this research study is consistent with labeling indications.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 260 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Madigan Army Medical Center is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
This arm will receive the placebo pill
Drug: Placebo
This arm will receive simethicone
Drug: Simethicone 80 MG
Patients will receive simethicone 80mg four times per day for 2 weeks post-operatively.
Patients in the control group will receive a placebo pill four times per day for 2 weeks
Pain
Postoperative pain score - based on patient completion of the APS Patient Outcome Questionnaire (APS-POQ-R). Scores are (1) pain severity and relief; (2) impact of pain on activity, sleep, and negative emotions; (3) side effects of treatment; (4) helpfulness of information about pain treatment; (5) ability to participate in pain treatment decisions; and (6) use of nonpharmacological strategies. 0 is no pain and 10 is severe/worst pain possible. Low scores are better outcomes.
Time frame: From enrollment through two weeks postoperatively
Opioid Use
Opioid use - measured via oral morphine equivalents based on chart review and post-operative survey with patient stated opioid use after discharge
Time frame: Immediate post-operatively (in PACU) through 2 weeks postoperatively
Gas and Bloating Score
PROMIS Scale v1.0 - Gastrointestinal Reflux 13a. The PROMIS Gastrointestinal Gas and Bloating Scale includes 13 items that assess the frequency, intensity, and severity of various gastrointestinal symptoms. More specifically, the items address bloating(i.e., feeling pressure or fullness), bloating appearance (i.e., belly swollen or larger than usual size), flatulence (i.e., passing gas), and abdominal sounds (i.e., gurgling or rumbling), as well as the predictability, bothersomeness, and interference with daily activities that result from these symptoms. This measure is not disease-specific and is intended for adult respondents (ages 18+). Scores are 1-5, with 1 being "Never" and 5 being "Very Much." Low scores are better outcomes.
Time frame: From enrollment to 14 days post-operatively
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Mar 2028, 35 months after the start.
Of 531 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's planned 35 months is above that.
Counting every sponsor, half of 541 studies reached it within 16 months; a quarter within 8 and three quarters within 32.
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Studies of the drug tested here: Simethicone
Madigan Army Medical Center