Simethicone as Part of ERAS in Bariatric Surgery Patients

NCT ID: NCT06812832

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-08
• Study Completion Date: 2029-03-31

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.

Conditions

Simethicone; Bariatric Surgery; Post-operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control Arm

This arm will receive the placebo pill

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients in the control group will receive a placebo pill four times per day for 2 weeks

Experimental Arm

This arm will receive simethicone

Group Type: EXPERIMENTAL

Simethicone 80 MG

Intervention Type: DRUG

Patients will receive simethicone 80mg four times per day for 2 weeks post-operatively.

Interventions

Simethicone 80 MG

Patients will receive simethicone 80mg four times per day for 2 weeks post-operatively.

Intervention Type: DRUG

Placebo

Patients in the control group will receive a placebo pill four times per day for 2 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Foregut procedures

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Madigan Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brooklyn Williams, DO

Role: CONTACT

brooklyn.c.williams3.mil@health.mil

(253) 968-3105

Christopher Porta, MD

Role: CONTACT

christopher.r.porta.civ@health.mil

(253) 968-3105

Facility Contacts

Christopher Porta, MD

Role: primary

christopher.r.porta.civ@health.mil

253-968-3105

Other Identifiers

971532

Identifier Type: -

Identifier Source: org_study_id