Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06372912
Other study ID # Complications-Bariatric-TJ
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Active, not recruiting NCT04583683 - Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities N/A
Completed NCT04099654 - The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery N/A
Completed NCT03809182 - Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels. Phase 4
Completed NCT03638843 - Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2 N/A
Withdrawn NCT05845359 - Intraoperative Methadone for Postoperative Pain Control Phase 4
Not yet recruiting NCT04343040 - Perioperative Evaluation of Glucose Profile Using Continuous Glucose Monitoring System in Glucose Intolerant Patients N/A
Withdrawn NCT03095404 - Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery Early Phase 1
Recruiting NCT03100292 - Korean OBEsity Surgical Treatment Study N/A
Active, not recruiting NCT04357119 - Common Limb Length in One-anastomosis Gastric Bypass N/A
Completed NCT03210207 - Gastric Plication in Mexican Patients N/A
Completed NCT04883268 - Focusing on Body Functionality After Bariatric Surgery N/A
Completed NCT02300168 - Neuromuscular Blockade: Outcome and Recovery for Laparoscopic Bariatric Surgery N/A
Unknown status NCT01264120 - The Impact of a Bariatric Rehabilitation Service on Patient Outcomes N/A
Recruiting NCT03972319 - Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study Early Phase 1
Terminated NCT04626232 - Comparison of the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique in Morbidly Obese Patients N/A
Completed NCT03643783 - Impact of Plasma Soluble Prorenin Receptor in Obese and Type 2 Diabetic Patients
Completed NCT04219852 - Contraception and Bariatric Surgery: Evaluation of Contraception and Contraceptive Knowledge of Women Undergoing Bariatric Surgery at the University Hospital of Reims
Recruiting NCT05570474 - Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery N/A