Incidence of Early Postoperative Complications in Patients Undergoing Bariatric Surgery in 2022 Tijuana, Baja California
| Registry | NCT06372912 |
| Status | Unknown |
| Study type | Observational |
| Enrollment | 3000 (Estimated) |
| Sponsor | Instituto Mexicano del Seguro Social (Other gov) |
| Conditions | Bariatric Surgery Candidate, Complication,Postoperative |
| Interventions | Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries. (Procedure) |
| Dates | start 2024-04-01, primary completion 2024-12-31 (estimated), completion 2024-12-31 (estimated), first posted 2024-04-18, last updated 2024-04-18 |
| Locations | 1 site in Mexico |
Related Papers Related Patents Related Grants Related Experts
All trials for Bariatric Surgery Candidate All trials for Complication,Postoperative All trials of Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries.
-Summary
This study examined immediate postoperative complications in patients undergoing various bariatric surgeries, aiming to evaluate the safety and efficacy of these interventions. Conducted at specialized high-volume bariatric surgery centers in Tijuana, Mexico. Predominantly female patients with severe obesity underwent procedures like sleeve gastrectomy and Roux-en-Y gastric bypass. Immediate complications were rare, occurring in only 0.38% of patients, with bleeding being the most common issue. Surgical reintervention within 48 hours was required in 0.33% of cases. The study's low complication rate suggests that surgeon expertise is crucial in minimizing risks and improving postoperative outcomes in bariatric surgery.
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+Detailed description
This study, conducted in specialised high-volume bariatric surgery centres in Tijuana, Baja California, Mexico, aimed to analyze the outcomes of various bariatric surgery procedures. It include patients who underwent surgeries like sleeve gastrectomy, gastric bypass, and others. The surgeries were performed by five specialized surgeons with assistance from ten bariatric surgery subspecialists. The researchers reviewed electronic medical records and excluded patients with incomplete information. Postoperative complications requiring additional medical or surgical interventions were noted. Statistical analysis was conducted using SPSS software, focusing on descriptive measures like frequencies, percentages, means, and standard deviations.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Patients undergoing bariatric surgery | | Procedure: Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries. | |
- Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries. (Procedure): Sleeve gastrectomy: reduces stomach size. Roux-en-Y gastric bypass: limits calorie absorption. Mini gastric bypass: achieves weight loss with fewer incisions. SADIS: combines sleeve gastrectomy with small bowel bypass. Intragastric balloon: reduces stomach volume. Gastric banding: restricts food intake.
+Outcome measures
Primary outcomes
- Rate of Postoperative Complications [30 days]: Within 30 days following surgery, the incidence of anastomotic leaks and surgical site bleeding is the main safety consequence. This outcome measure is essential for proving the safety and enhanced recovery profile, since the technique emphasizes rigorous hemostasis and anastomotic integrity-achieved through reinforced suturing and patency verification using methylene blue tests.
Secondary outcomes
- Long-term Weight Loss Efficacy [12 months]: : The percentage of excess weight loss (%EWL) at 12 months after surgery is the main indicator of efficacy. One of the main objectives of bariatric surgery is to achieve significant and long-lasting weight loss. The percentage EWL is calculated using the patient's weight reduction from pre-surgery to a year after surgery, normalized to their excess weight using optimum body weight guidelines.
+Eligibility
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria:
* Patients aged 18 years and above
* Varying degrees of overweight or obesity who underwent surgery at the participating hospitals
Exclusion Criteria:
* incomplete or insufficient information in their medical records
+Locations (1)
| Facility | City | Country | Status |
|---|
| Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico. | Tijuana, Estado de Baja California | Mexico | Recruiting |
+Investigators
- Jesús E Ortiz Gómez, MD, PhD, Study director, Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.
- Almino Cardoso Ramos, MD, PhD, Study chair, Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.
- Jaime Ponce de León Palomares, MD, PhD, Study chair, Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico.
- José S Verboonen Sotelo, MD, PhD, Study chair, Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico
- Jeffry Romero Manzano, MD, PhD, Study chair, Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico.
- Isaac Esparza Estrada, MD, PhD, Study chair, Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico
- Alejandro González Ojeda, MD, PhD, Study chair, Professor at the Faculty of Medicine of the Universidad de Colima. Colima, Mexico
- Christian Rodríguez López, MD, PhD, Study chair, Body Art Surgical, Edificio Corporativo Central, Diego Rivera 2311, Zona Urbana Rio Tijuana, 22010 Tijuana, Baja California, Mexico.
- Clotilde Fuentes-Orozco, MD, PhD, Study chair, Senior Researcher B, Biomedical Research. Unidad de Investigación Biomédica 02, Unidad Médica de Alta Especialidad, Hospital de Especialidades del Centro Médico Nacional de Occidente del Instituto Mexicano del Seguro Social. Guadalajara, Jalisco. México
- Sergio J Vázquez-Sánchez, MD, Study chair, Unidad de Investigación Biomédica 02, Unidad Médica de Alta Especialidad, Hospital de Especialidades del Centro Médico Nacional de Occidente del Instituto Mexicano del Seguro Social
- Hector J Pérez Corzo, MD, PhD, Study chair, Renew Bariatrics, Bariatric Surgery Department, Tijuana, Baja California, Mexico
- José O Orozco Álvarez Malo, MD, PhD, Study chair, Colegio de Cirujanos Bariatras y Enfermedades Metabólicas del Estado de Baja California. Tijuana 2050, Baja California, Mexico.
- Jhonattan A Barriga Fong, MD, PhD, Study chair, Colegio de Cirujanos Bariatras y Enfermedades Metabólicas del Estado de Baja California. Tijuana 2050, Baja California, Mexico