Simethicone to reduce gas pain after foregut and bariatric surgery
Simethicone as Part of an Enhanced Recovery After Surgery (ERAS) Protocol
PHASE4 · Madigan Army Medical Center · NCT06812832
This trial will test whether simethicone (Gas-X) reduces gas pain and bloating in adults having foregut operations such as sleeve gastrectomy or gastric bypass.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Madigan Army Medical Center (fed) |
| Locations | 1 site (Tacoma, Washington) |
| Trial ID | NCT06812832 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized, placebo-controlled Phase 4 trial enrolls adult patients undergoing foregut procedures at Madigan Army Medical Center. Participants complete a baseline PROMIS Gastrointestinal Gas and Bloating survey, are randomized to receive either simethicone 80 mg or placebo four times daily after surgery, and repeat the PROMIS survey and the APS-POQ-R pain questionnaire 24 hours postoperatively (and daily if admitted longer). The research pharmacist and study statistician are the only unblinded personnel, and all other team members and patients are blinded to allocation. The study is designed to gather safety data and measure symptomatic benefit of simethicone in the immediate postoperative period.
Who should consider this trial
Good fit: Adults scheduled for foregut operations (including sleeve gastrectomy, Roux-en-Y gastric bypass, hiatal hernia, or other gastric surgery) who are not pregnant and do not have a simethicone allergy are eligible.
Not a fit: Patients having non-foregut procedures, minors under 18, pregnant or breastfeeding individuals, or those allergic to simethicone are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, patients may have less postoperative gas pain and bloating, leading to greater comfort and an easier early recovery.
How similar studies have performed: Simethicone is an established over-the-counter remedy for gas, but randomized trials specifically targeting postoperative foregut patients are limited, so this application is relatively understudied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Foregut procedures Exclusion Criteria: * Non-foregut procedures * Allergy to simethicone * Pregnancy or breastfeeding * Minors under 18 years of age
Where this trial is running
Tacoma, Washington
- Madigan Army Medical Center — Tacoma, Washington, United States (RECRUITING)
Study contacts
- Study coordinator: Brooklyn Williams, DO
- Email: brooklyn.c.williams3.mil@health.mil
- Phone: (253) 968-3105
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Simethicone, Bariatric Surgery, Post-operative Pain, Gas-X, Foregut, Post-operative pain