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Simethicone as Part of ERAS in Bariatric Surgery Patients

NCT06812832 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-06-15

No results posted yet for this study

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.

Conditions

  • Simethicone
  • Bariatric Surgery
  • Post-operative Pain

Interventions

DRUG

Simethicone 80 MG

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Madigan Army Medical Center

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-08
Primary Completion
2028-03-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06812832 on ClinicalTrials.gov