Simethicone as Part of ERAS in Bariatric Surgery Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-89
SponsorMadigan Army Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Foregut procedures
Disqualifiers
Non-foregut procedures
Allergy to simethicone
Pregnancy or breastfeeding
Minors under 18 years of age
Trial design
Design model
Parallel
Treatments tested in this trial
Simethicone 80 MG
DrugPatients will receive simethicone 80mg four times per day for 2 weeks post-operatively.
Placebo
DrugPatients in the control group will receive a placebo pill four times per day for 2 weeks
Treatment groups
260 Participants
are divided into 2 treatment groupsGroup A: Control ArmPlacebo comparator 1 intervention
Group B: Experimental ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment through two weeks postoperatively2
Opioid Use
Opioid use - measured via oral morphine equivalents based on chart review and post-operative survey with patient stated opioid use after discharge
Time frame
Immediate post-operatively (in PACU) through 2 weeks postoperatively3
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.
Time frame
From enrollment to 14 days post-operativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov