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The goal of this observational study is to learn about incidence of postoperative gastroesophageal reflux disease in mandatory hiatoplasty performed during gastric sleeve surgery.
The main question[s] it aims to answer are:
Participants will answer a follow-up questionnaire, about postoperative quality of life
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants without postoperative GERD | To evaluate the efficacy of mandatory hiatoplasty performed during gastric sleeve surgery in reducing the incidence of postoperative gastroesophageal reflux disease (GERD) in patients undergoing this procedure in a hospital specializing in bariatric surgery in Tijuana, Baja California. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comorbidities in patients undergoing gastric sleeve with hiatoplasty | These patients usually have significant obesity, often accompanied by comorbidities such as type 2 diabetes, hypertension, sleep apnea, and gastroesophageal reflux disease (GERD). | 6 months |
| Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty |
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Inclusion Criteria:
Exclusion Criteria:
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Patients over 18 years of age of indistinct gender who underwent gastric sleeve with hiatoplasty for obesity or overweight management in a hospital center specialized in bariatric surgery in Tijuana, Baja California.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alejandro Gonzalez-Ojeda, MD, PhD | Contact | 3331294165 | avygail5@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| José Aldo Guzmán-Barba, MD, PhD | ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México. | Study Chair |
| Alejandro López-Ortega, MD, PhD | ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, Mexico | Recruiting | Guadalajara | Jalisco | 44329 |
Data will be kept absolutely confidential
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 10, 2024 | Mar 11, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D011178 | Postgastrectomy Syndromes |
| D005764 | Gastroesophageal Reflux |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
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Hiatoplasty is often performed to reduce the risk of postoperative GERD by repairing a herniated hiatus during gastric sleeve surgery. However, the exact incidence of postoperative GERD can vary and depends on factors such as surgical technique, patient anatomy and postoperative management. |
| 6 months |
| Comparison of postoperative complication rates, including GERD | Postoperative complications may include, but are not limited to, bleeding, infection, sleeve stenosis, and GERD recurrence. Comparison of complication rates between patients with and without mandatory hiatoplasty may provide insight into the effectiveness of this technique in mitigating specific risks. | 6 months |
| Postoperative quality of life analysis | Questionnaire postoperative quality of life with the Bariatric Analysis and Reporting Outcome System (BAROS) Questionnaire | 6 months |
| Study Director |
| Helmut Heribert, MD, PhD | ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México. | Principal Investigator |
| Isaac Esparza Estrada, MD, PhD | ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México. | Study Chair |
| Sergio Jiram Vazquez-Sánchez, MD | Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, Mexico | Study Chair |
| Alejandro González-Ojeda, MD, PhD | Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, Mexico | Study Chair |
| Mexico |
|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |