Marginal Ulcers
Conditions
Keywords
gastric bypass surgery, anastomosis, Roux-en-Y, Complication, Postoperative
Brief summary
This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an ulcer after gastric bypass surgery.
Detailed description
The purpose of this research is to evaluate information about the control of gastric acid in post gastric bypass surgery patients. Goal is to determine which medication best reduces the incidence of anastomotic ulcers post-operatively.
Interventions
DRUGOmeprazole
40mg dose administered as a suspension or capsule as physician directs daily at bedtime for 14 weeks beginning day of hospital discharge following gastric bypass surgery.
DRUGFamotidine
40mg dose administered as a suspension or capsule as physician directs daily at bedtime for 14 weeks beginning day of hospital discharge following gastric bypass surgery.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is age ≥ 18 years * Patient meets the criteria for laparoscopic gastric bypass surgery * Females only: Patient is willing to take a urine pregnancy test
Exclusion criteria
* Subject allergic to omeprazole or famotidine * Patient receiving antifungal (i.e. ketoconazole or itraconazole) * Hepatic insufficiency * History of Crohns disease * History of Zollinger-Ellison disease * Patient received an investigational drug within 30 days of enrollment * Patient currently enrolled in another research project * Females Only: Pregnancy or plan on becoming pregnant during the next 14 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia. | during first 14 weeks after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Upper Endoscopy Indicated Due to Complaints | during first 14 weeks after surgery | Endoscopic visualization of presence or absence of anastomotic ulcers if upper endoscopy indicated due to patient complaints - based upon severity of complaints |
Countries
United States
Participant flow
Recruitment details
Study participants were recruited from patients preparing for Roux-en-Y gastric bypass (RYGB) at Missouri Bariatric Services, the bariatric clinic associated with University of Missouri. Patients were recruited from November 2006 through November 2007.
Pre-assignment details
While study participants were enrolled prior to their RYGB, they did not begin the study drug until after discharge from the hospital post-RYGB. During that time some patients were excluded, whether it was because the patient's surgery was cancelled or because the patient no longer met the inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Omeprazole 40 mg daily for 14 weeks | 22 |
| Famotidine 40 mg daily for 14 weeks | 18 |
| Total | 40 |
Baseline characteristics
| Characteristic | Omeprazole | Famotidine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 18 Participants | 40 Participants |
| Region of Enrollment United States | 22 participants | 18 participants | 40 participants |
| Sex/Gender, Customized Female | 14 participants | 0 participants | 14 participants |
| Sex/Gender, Customized Male | 8 participants | 0 participants | 8 participants |
| Sex/Gender, Customized Unknown | 0 participants | 18 participants | 18 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 13 |
| serious Total, serious adverse events | 0 / 17 | 0 / 13 |
Outcome results
Primary
Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.
Time frame: during first 14 weeks after surgery
Population: Patients lost to follow-up were not included in the data analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omeprazole | Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia. | 17 participants |
| Famotidine | Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia. | 13 participants |
Secondary
Number of Participants With Upper Endoscopy Indicated Due to Complaints
Endoscopic visualization of presence or absence of anastomotic ulcers if upper endoscopy indicated due to patient complaints - based upon severity of complaints
Time frame: during first 14 weeks after surgery
Population: Patients lost to follow-up were not included in the study analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omeprazole | Number of Participants With Upper Endoscopy Indicated Due to Complaints | 1 participants |
| Famotidine | Number of Participants With Upper Endoscopy Indicated Due to Complaints | 13 participants |