Simethicone as Part of ERAS in Bariatric Surgery Patients

Part of paid clinical trials in Tacoma, Washington.

Sponsor
Madigan Army Medical Center
Study ID
NCT06812832
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Bariatric Surgery
  • Post-operative Pain
  • Simethicone

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • Simethicone 80 MG — DRUG
    Patients will receive simethicone 80mg four times per day for 2 weeks post-operatively.
  • Placebo — DRUG
    Patients in the control group will receive a placebo pill four times per day for 2 weeks

Study Details

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.

Key Dates

Start date
Apr 8, 2025
Status verified
Jan 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Control Arm
    This arm will receive the placebo pill
  • Experimental: Experimental Arm
    This arm will receive simethicone

Primary Outcome Measure

Pain [ Time Frame: From enrollment through two weeks postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Madigan Army Medical CenterTacomaWashington98431
Christopher Porta, MD
[email protected]
253-968-3105

Find similar trials in Tacoma, WA

By research site
Madigan Army Medical Center· Tacoma, WA

Related Studies