Early Postoperative Complications in Patients Undergoing Bariatric Surgery

Incidence of Early Postoperative Complications in Patients Undergoing Bariatric Surgery in 2022 Tijuana, Baja California

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.

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery Candidate; Complication,Postoperative
• Intervention / Treatment: Procedure: Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries.

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.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: José A Guzmán Barba, MD, PhD; Phone Number: 3471043237; Email: aldogbarba@hotmail.com

Study Locations

• Mexico
  • Baja California
    • Tijuana, Baja California, Mexico, 22046
      • Recruiting
      • Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.
      • Contact: José a Guzmán Barba, MD, PhD; Phone Number: 3471043237; Email: • aldogbarba@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study included patients aged 18 and above with varying degrees of overweight or obesity who underwent bariatric surgery at specialized centers in Tijuana, Mexico. The surgeries examined were sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement. These procedures were performed by five bariatric surgery specialists with assistance from ten certified subspecialists. Patients with incomplete medical records were excluded. Immediate postoperative complications were defined as events requiring additional medical or surgical interventions beyond routine care.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Postoperative Complications	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term Weight Loss Efficacy	: 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.	12 months

Collaborators and Investigators

• Sponsor: Instituto Mexicano del Seguro Social
• Investigators: Study Director: Jesús E Ortiz Gómez, MD, PhD, Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.; Study Chair: Almino Cardoso Ramos, MD, PhD, Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.; Study Chair: Jaime Ponce de León Palomares, MD, PhD, Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico.; Study Chair: José S Verboonen Sotelo, MD, PhD, Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico; Study Chair: Jeffry Romero Manzano, MD, PhD, Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico.; Study Chair: Isaac Esparza Estrada, MD, PhD, Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico; Study Chair: Alejandro González Ojeda, MD, PhD, Professor at the Faculty of Medicine of the Universidad de Colima. Colima, Mexico; Study Chair: Christian Rodríguez López, MD, PhD, Body Art Surgical, Edificio Corporativo Central, Diego Rivera 2311, Zona Urbana Rio Tijuana, 22010 Tijuana, Baja California, Mexico.; Study Chair: Clotilde Fuentes-Orozco, MD, PhD, 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; Study Chair: Sergio J Vázquez-Sánchez, MD, 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; Study Chair: Hector J Pérez Corzo, MD, PhD, Renew Bariatrics, Bariatric Surgery Department, Tijuana, Baja California, Mexico; Study Chair: José O Orozco Álvarez Malo, MD, PhD, Colegio de Cirujanos Bariatras y Enfermedades Metabólicas del Estado de Baja California. Tijuana 2050, Baja California, Mexico.; Study Chair: Jhonattan A Barriga Fong, MD, PhD, Colegio de Cirujanos Bariatras y Enfermedades Metabólicas del Estado de Baja California. Tijuana 2050, Baja California, Mexico

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: Complications-Bariatric-TJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No