Simethicone as Part of ERAS in Bariatric Surgery Patients

NCT06812832 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 971532
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Simethicone; Bariatric Surgery; Post-operative Pain

Keywords

Simethicone; Gas-X; Foregut; Post-operative pain

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Control Arm

PLACEBO COMPARATOR

This arm will receive the placebo pill

Drug: Placebo

Experimental Arm

EXPERIMENTAL

This arm will receive simethicone

Drug: Simethicone 80 MG

Interventions

Simethicone 80 MG DRUG

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

Experimental Arm

Placebo DRUG

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

Control Arm

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Foregut procedures

You may not qualify if:

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

Sponsors & Collaborators

• Madigan Army Medical Center: lead

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Simethicone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Brooklyn Williams, DO

CONTACT

(253) 968-3105; brooklyn.c.williams3.mil@health.mil

Christopher Porta, MD

CONTACT

(253) 968-3105; christopher.r.porta.civ@health.mil

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: April 8, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)