Early Postoperative Complications in Patients Undergoing Bariatric Surgery

NCT06372912 | Recruiting

• 1 other identifier: Complications-Bariatric-TJ
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; Complication,Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Long-term Weight Loss Efficacy

  12 months

Study Arms (1)

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.

Interventions

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.

Patients undergoing bariatric surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients aged 18 years and above
• Varying degrees of overweight or obesity who underwent surgery at the participating hospitals

You may not qualify if:

• incomplete or insufficient information in their medical records

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.

Tijuana, Estado de Baja California, 22046, Mexico

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Jesús E Ortiz Gómez, MD, PhD

  Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.

  STUDY DIRECTOR

• 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 CHAIR

Central Study Contacts

José A Guzmán Barba, MD, PhD

CONTACT

3471043237; aldogbarba@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)