Early Postoperative Complications in Patients Undergoing Bariatric Surgery

NCT ID: NCT06372912

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Bariatric Surgery Candidate Complication,Postoperative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients undergoing bariatric surgery

Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries.

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

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GONZALEZ-OJEDA ALEJANDRO

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jesús E Ortiz Gómez, MD, PhD

Role: STUDY_DIRECTOR

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

Almino Cardoso Ramos, MD, PhD

Role: STUDY_CHAIR

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

Jaime Ponce de León Palomares, MD, PhD

Role: STUDY_CHAIR

Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico.

José S Verboonen Sotelo, MD, PhD

Role: STUDY_CHAIR

Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico

Jeffry Romero Manzano, MD, PhD

Role: STUDY_CHAIR

Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico.

Isaac Esparza Estrada, MD, PhD

Role: STUDY_CHAIR

Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico

Alejandro González Ojeda, MD, PhD

Role: STUDY_CHAIR

Professor at the Faculty of Medicine of the Universidad de Colima. Colima, Mexico

Christian Rodríguez López, MD, PhD

Role: 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

Role: 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

Role: 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

Role: STUDY_CHAIR

Renew Bariatrics, Bariatric Surgery Department, Tijuana, Baja California, Mexico

José O Orozco Álvarez Malo, MD, PhD

Role: 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

Role: STUDY_CHAIR

Colegio de Cirujanos Bariatras y Enfermedades Metabólicas del Estado de Baja California. Tijuana 2050, Baja California, Mexico

Locations

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

Tijuana, Estado de Baja California, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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José A Guzmán Barba, MD, PhD

Role: CONTACT

3471043237

Facility Contacts

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José a Guzmán Barba, MD, PhD

Role: primary

Other Identifiers

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Complications-Bariatric-TJ

Identifier Type: -

Identifier Source: org_study_id

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