Simethicone as Part of ERAS in Bariatric Surgery Patients

Simethicone as Part of an Enhanced Recovery After Surgery (ERAS) Protocol

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.

Study Overview

• Status: Recruiting
• Conditions: Post-operative Pain; Bariatric Surgery; Simethicone
• Intervention / Treatment: Drug: Placebo; Drug: Simethicone 80 MG

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 Type: Interventional
• Enrollment (Estimated): 260
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Brooklyn Williams, DO; Phone Number: (253) 968-3105; Email: brooklyn.c.williams3.mil@health.mil
• Study Contact Backup: Name: Christopher Porta, MD; Phone Number: (253) 968-3105; Email: christopher.r.porta.civ@health.mil

Study Locations

• United States
  • Washington
    • Tacoma, Washington, United States, 98431
      • Recruiting
      • Madigan Army Medical Center
      • Contact: Christopher Porta, MD; Phone Number: 253-968-3105; Email: christopher.r.porta.civ@health.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Foregut procedures

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Arm; This arm will receive the placebo pill	Drug: Placebo; Patients in the control group will receive a placebo pill four times per day for 2 weeks
Experimental: Experimental Arm; This arm will receive simethicone	Drug: Simethicone 80 MG; Patients will receive simethicone 80mg four times per day for 2 weeks post-operatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Use	Opioid use - measured via oral morphine equivalents based on chart review and post-operative survey with patient stated opioid use after discharge	Immediate post-operatively (in PACU) through 2 weeks postoperatively
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.	From enrollment through two 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.	From enrollment to 14 days post-operatively

Collaborators and Investigators

• Sponsor: Madigan Army Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Simethicone; Post-operative pain; Gas-X; Foregut
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Emollients; Antifoaming Agents; Simethicone
• Other Study ID Numbers: 971532

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes