Early Postoperative Complications in Patients Undergoing Bariatric Surgery

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06372912
• Other study ID #: Complications-Bariatric-TJ
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Instituto Mexicano del Seguro Social
• Contact: José A Guzmán Barba, MD, PhD
• Phone: 3471043237
• Email: aldogbarba[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Complication,Postoperative
• Postoperative Complications

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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