Clinical trial NCT06372912: Early Postoperative Complications in Patients Undergoing Bariatric Surgery
Official title: Incidence of Early Postoperative Complications in Patients Undergoing Bariatric Surgery in 2022 Tijuana, Baja California
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery Candidate
Complication,Postoperative
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2024-04-18
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Postoperative Complications
timeFrame: 30 days
Secondary outcomes:
measure: Long-term Weight Loss Efficacy
timeFrame: 12 months
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.
state: Baja California
Study officials:
affiliation: Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.
name: Jesús E Ortiz Gómez, MD, PhD
role: STUDY_DIRECTOR
affiliation: Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.
name: Almino Cardoso Ramos, MD, PhD
role: STUDY_CHAIR
affiliation: Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico.
name: Jaime Ponce de León Palomares, MD, PhD
role: STUDY_CHAIR
affiliation: Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico
name: José S Verboonen Sotelo, MD, PhD
role: STUDY_CHAIR
affiliation: Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico.
name: Jeffry Romero Manzano, MD, PhD
role: STUDY_CHAIR
affiliation: Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico
name: Isaac Esparza Estrada, MD, PhD
role: STUDY_CHAIR
affiliation: Professor at the Faculty of Medicine of the Universidad de Colima. Colima, Mexico
name: Alejandro González Ojeda, MD, PhD
role: STUDY_CHAIR
affiliation: Body Art Surgical, Edificio Corporativo Central, Diego Rivera 2311, Zona Urbana Rio Tijuana, 22010 Tijuana, Baja California, Mexico.
name: Christian Rodríguez López, MD, PhD
role: STUDY_CHAIR
affiliation: 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
name: Clotilde Fuentes-Orozco, MD, PhD
role: STUDY_CHAIR
affiliation: 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
name: Sergio J Vázquez-Sánchez, MD
role: STUDY_CHAIR
affiliation: Renew Bariatrics, Bariatric Surgery Department, Tijuana, Baja California, Mexico
name: Hector J Pérez Corzo, MD, PhD
role: STUDY_CHAIR
affiliation: Colegio de Cirujanos Bariatras y Enfermedades Metabólicas del Estado de Baja California. Tijuana 2050, Baja California, Mexico.
name: José O Orozco Álvarez Malo, MD, PhD
role: STUDY_CHAIR
affiliation: Colegio de Cirujanos Bariatras y Enfermedades Metabólicas del Estado de Baja California. Tijuana 2050, Baja California, Mexico
name: Jhonattan A Barriga Fong, MD, PhD
role: STUDY_CHAIR
References: