Simethicone Protocol

Phase 4

Not yet recruiting

• Conditions: Simethicone; Bariatric Surgery; Post-operative Pain
• Interventions: Drug: Placebo; Drug: Simethicone 80 MG

• Registration Number: NCT06812832
• Lead Sponsor: Madigan Army Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-01-31
• Last Update Submitted: 2025-01-31
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06
• Study Start: 2025-03
• Primary Completion: 2028-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Foregut procedures

Exclusion Criteria

• Non-foregut procedures
• Allergy to simethicone
• Pregnancy or breastfeeding
• Minors under 18 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Placebo	This arm will receive the placebo pill
Experimental Arm	Simethicone 80 MG	This arm will receive simethicone

Primary Outcome Measures

Name	Time	Method
Gas/bloating symptoms	From enrollment through 2 weeks post-operatively	Baseline, 24h, and postoperative gas/bloating symptoms - based on patient completion of PROMIS Scale v1.1 - Gastrointestinal Gas and Bloating 13a
Pain	From enrollment through two weeks postoperatively	Postoperative pain score - based on patient completion of the APS Patient Outcome Questionnaire (APS-POQ-R)
Opioid Use	Immediate post-operatively (in PACU) through 2 weeks postoperatively	Opioid use - measured via oral morphine equivalents based on chart review and post-operative survey with patient stated opioid use after discharge