Simethicone for Gas and Bloating After Bariatric Surgery
This study is looking at whether simethicone (also known as Gas Relief or Gas-X) can help reduce gas pain and bloating after certain stomach surgeries, including weight-loss (bariatric) procedures. Researchers want to see if simethicone improves pain, reduces the need for pain medication (opioids), and lessens gas and bloating. You might be able to join if you are between 18 and 89 years old and are having a stomach surgery like sleeve gastrectomy or gastric bypass. The study is currently unclear about its recruitment status, but plans to enroll 260 people. Simethicone is already approved by the FDA for gas relief, and this study aims to understand its specific benefits after these surgeries.
- Study design
- This is an interventional study where 260 participants will be randomly assigned to receive either simethicone or a placebo (an inactive pill). Neither you nor your doctors will know which treatment you are receiving.
- What's involved
- You would complete surveys about gas and bloating before and after your surgery. After surgery, you would take either simethicone or a placebo pill four times a day for two weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for pain, opioid use, and gas/bloating scores from enrollment through two weeks after your surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Simethicone as Part of ERAS in Bariatric Surgery Patients
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- PainFrom enrollment through two weeks postoperatively
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.
- Opioid UseImmediate post-operatively (in PACU) through 2 weeks postoperatively
Opioid use - measured via oral morphine equivalents based on chart review and post-operative survey with patient stated opioid use after discharge
- Gas and Bloating ScoreFrom enrollment to 14 days post-operatively
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.