Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The hypothesis of this study was that gastric bypass (GBP) ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients.
The investigators studied the impact of this surgical procedure on GERD in patients with morbid obesity.
Esophageal syndromes were evaluated according to the Montreal Consensus, where troublesome symptoms were defined as score ā„ 2 on a validated questionnaire of symptoms for Portuguese language along with esophageal syndromes with injury assessed through upper endoscopy.
Esophageal acid exposure was determined through 24h pH monitoring. Increased acid exposure was characterized when total esophageal pH < 4 for at least 4% of the total monitoring time.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients assessed for GERD | Patients who had an open gastric bypass were assessed for GERD before and after surgery following the Montreal Consensus through a validated questionnaire in Portuguese language |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric bypass | Procedure | Open SilasticĀ® ring Roux-en Y gastric bypass was performed through an upper midline incision. A gastric pouch was created by dividing the stomach with a 10-cm stapler from the lesser curvature (7 cm vertically from the cardia) to 1 cm to the left of the Hiss angle. The estimated volume of the gastric pouch was 20 to 30 ml that was banded with a 6.5 cm long SilasticĀ® ring. A gastrojejunal anastomosis was performed with two-layers hand sewn absorbable suture over a 1.2 cm bougie distal to the ring, keeping an alimentary limb with 100 cm in length, and a biliopancreatic limb ranging 60 and 80 cm. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Presenting Reflux Symptoms | Prevalence of typical reflux syndrome according to the Montreal Consensus. This Consensus institutes that GERD can be outlined when troublesome symptoms and/or complications induced by reflux of the gastric content back to the esophagus are present. In order to assess such troublesome symptoms a validated questionnaire translated into Portuguese language was used. | Before GBP, 6 months after GBP and 39 months after GBP |
| Number of Participants With Esophageal Injury | Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis | Before GBP, 6 months after GBP and 39 months after GBP |
| Number of Participants With Gastroesophageal Reflux Disease (GERD) | Prevalence of GERD in patients characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus. | Before GBP, 6 months after GBP and 39 months after GBP |
| Total Esophageal Acid Exposure at 24h pH Monitoring | Esophageal acid exposure was measured through 24h pH monitoring. During the entire period, esophageal pH was measured and recorded as the percent of time pH was below 4. | Before GBP, 6 months after GBP and 39 months after GBP |
| Esophageal Acid Exposure at 24h pH Monitoring in Upright Position | Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in upright position | Before GBP, 6 months after GBP and 39 months after GBP |
| Esophageal Acid Exposure at 24h pH Monitoring in Supine Position |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Primary care clinic patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carlos AS Madalosso, PhD | Clinica Gastrobese | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClĆnica Gastrobese | Passo Fundo | Rio Grande do Sul | 99010112 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20010088 | Derived | Madalosso CA, Gurski RR, Callegari-Jacques SM, Navarini D, Thiesen V, Fornari F. The impact of gastric bypass on gastroesophageal reflux disease in patients with morbid obesity: a prospective study based on the Montreal Consensus. Ann Surg. 2010 Feb;251(2):244-8. doi: 10.1097/SLA.0b013e3181bdff20. |
Not provided
Not provided
Not provided
126 consecutive patients were assessed on site (Gastrobese Clinic) between March and October 2007, 94 met the criteria.
8 patients were lost to follow-up, 4 before and 4 after GBP. Out of those, 15 were lost to follow-up and 18 refused to follow through, resulting on the actual 53 patients.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patients Assessed for GERD | Patients assessed for GERD before and after Gastric Bypass Surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Before GBP |
| |||||||||||||
| 6 Months After GBP |
|
Patients were enrolled irrespective of GERD symptoms according to the following criteria:
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patients Assessed for GERD | Patients who had an open gastric bypass were assessed for GERD before and after surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Presenting Reflux Symptoms | Prevalence of typical reflux syndrome according to the Montreal Consensus. This Consensus institutes that GERD can be outlined when troublesome symptoms and/or complications induced by reflux of the gastric content back to the esophagus are present. In order to assess such troublesome symptoms a validated questionnaire translated into Portuguese language was used. | Posted | Number | participants | Before GBP, 6 months after GBP and 39 months after GBP |
|
Not provided
Serious and Other Non-Serious Adverse Events were not collected/assessed during the study
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Assessed for GERD | Patients who had an open gastric bypass were assessed for GERD before and after surgery |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carlos AS Madalosso, Director of Department of Metabolic and Bariatric Surgery | Clinica Gastrobese | +55(54)3045-4070 | madalosso@gastrobese.com.br |
Not provided
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
|
Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in supine position |
| Before GBP, 6 months after GBP and 39 months after GBP |
| Number of Participants With Increased Acid Exposure | Increased Acid Exposure occurs when esophageal pH is <4 for a period longer than 4% of the total test time on a 24h pH monitoring. | Before GBP, 6 months after GBP and 39 months after GBP |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 39 Months After GBP | Patients assessed for GERD 39 months after Gastric Bypass Surgery |
|
|
|
| Primary | Number of Participants With Esophageal Injury | Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis | Posted | Number | participants | Before GBP, 6 months after GBP and 39 months after GBP |
|
|
|
|
| Primary | Number of Participants With Gastroesophageal Reflux Disease (GERD) | Prevalence of GERD in patients characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus. | Posted | Number | participants | Before GBP, 6 months after GBP and 39 months after GBP |
|
|
|
|
| Primary | Total Esophageal Acid Exposure at 24h pH Monitoring | Esophageal acid exposure was measured through 24h pH monitoring. During the entire period, esophageal pH was measured and recorded as the percent of time pH was below 4. | Posted | Median | Inter-Quartile Range | percentage of time | Before GBP, 6 months after GBP and 39 months after GBP |
|
|
|
|
| Primary | Esophageal Acid Exposure at 24h pH Monitoring in Upright Position | Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in upright position | Posted | Median | Inter-Quartile Range | percentage of time | Before GBP, 6 months after GBP and 39 months after GBP |
|
|
|
|
| Primary | Esophageal Acid Exposure at 24h pH Monitoring in Supine Position | Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in supine position | Posted | Median | Inter-Quartile Range | percentage of time | Before GBP, 6 months after GBP and 39 months after GBP |
|
|
|
|
| Primary | Number of Participants With Increased Acid Exposure | Increased Acid Exposure occurs when esophageal pH is <4 for a period longer than 4% of the total test time on a 24h pH monitoring. | Posted | Number | participants | Before GBP, 6 months after GBP and 39 months after GBP |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
Not provided
| D004066 | Digestive System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005763 |
| Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |