Actively Recruiting
Simethicone as Part of an Enhanced Recovery After Surgery (ERAS) Protocol in Bariatric Surgery Patients
Led by Madigan Army Medical Center · Updated on 2025-06-15
260
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether simethicone, also known as Gas Relief or Gas-X, can help reduce gas pain and bloating in patients undergoing foregut surgeries such as bariatric procedures (sleeve gastrectomy, Roux-en-Y gastric bypass), hiatal hernia repair, and other gastric surgeries. The study focuses on assessing the safety and effectiveness of simethicone in this specific patient group. Simethicone is an FDA-approved medication commonly used to relieve pressure, bloating, and fullness caused by gas. Participants will be randomly assigned to receive either simethicone 80 mg or a placebo four times daily for 14 days following their surgery. The first dose will be administered after the surgical procedure, and dosing will continue during the hospital stay and after discharge to complete a total of 56 doses. Randomization is done without restrictions, and only the research pharmacist and statistician will know which treatment each patient receives. Participants will complete surveys measuring gas and bloating symptoms before surgery, 24 hours after surgery, daily during any extended hospital stay, and again at their follow-up visit two weeks postoperatively. These include the PROMIS Scale v1.1 for Gastrointestinal Gas and Bloating and the APS Patient Outcome Questionnaire. Data will be collected confidentially and analyzed to assess outcomes such as pain, opioid use, and gas and bloating scores. The entire project is planned to last four years, including enrollment and data analysis.
CONDITIONS
Brief Title
Simethicone as Part of ERAS in Bariatric Surgery Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing foregut surgical procedures such as bariatric surgery, hiatal hernia repair, or gastric surgery
You will not qualify if you...
- Patients undergoing non-foregut procedures
- Allergy to simethicone
- Pregnancy or breastfeeding
- Individuals under 18 years of age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants undergo bariatric surgery and receive either simethicone or placebo four times per day for 14 days post-operatively.
Daily inpatient visits plus 1 follow-up visit after discharge
Duration - Up to 2 weeks after surgery
Participants complete surveys at their standard postoperative follow-up visit to assess gas and bloating and medication compliance.
1 standard postoperative follow-up visit
Trial Site Locations
Total: 1 location
1
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Actively Recruiting
Research Team
B
Brooklyn Williams, DO
C
Christopher Porta, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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