Bariatric Surgery CandidateNCT06372912
Early Postoperative Complications in Patients Undergoing Bariatric Surgery
An observational study of Bariatric Surgery Candidate and Complication,Postoperative, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate, Complication,Postoperative
- What is being tested?
- Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries.
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteMexico
- Study dates
- 1 Apr 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients aged 18 years and above
- Varying degrees of overweight or obesity who underwent surgery at the participating hospitals
Who cannot join
- incomplete or insufficient information in their medical records
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.
Tijuana, Estado de Baja California, 22046
José a Guzmán Barba, MD, PhD, 3471043237, • aldogbarba@hotmail.com
About this study
Official title: Incidence of Early Postoperative Complications in Patients Undergoing Bariatric Surgery in 2022 Tijuana, Baja California
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.
Read the 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.
- Being tested
- Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries.
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing bariatric surgery | Not described Receives: Procedure: Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Apr 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social
- Investigators
- Jesús E Ortiz Gómez, MD, PhD, Study director, Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.Almino Cardoso Ramos, MD, PhD, Study chair, Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.Jaime Ponce de León Palomares, MD, PhD, Study chair, Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico.José S Verboonen Sotelo, MD, PhD, Study chair, Obesity Goodbye Center, Tijuana 2050, Baja California, MexicoJeffry Romero Manzano, MD, PhD, Study chair, Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico.Isaac Esparza Estrada, MD, PhD, Study chair, Obesity Goodbye Center, Tijuana 2050, Baja California, MexicoAlejandro González Ojeda, MD, PhD, Study chair, Professor at the Faculty of Medicine of the Universidad de Colima. Colima, MexicoChristian Rodríguez López, MD, PhD, Study chair, Body Art Surgical, Edificio Corporativo Central, Diego Rivera 2311, Zona Urbana Rio Tijuana, 22010 Tijuana, Baja California, Mexico.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372912
- Sponsor's protocol ID
- Complications-Bariatric-TJ
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Early Postoperative Complications in Patients Undergoing Bariatric Surgery in 2022 Tijuana, Baja California
- ClinicalTrials.gov ID
- NCT06372912
- Acronym / sponsor ID
- Complications-Bariatric-TJ
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients aged 18 years and above
- Varying degrees of overweight or obesity who underwent surgery at the participating hospitals
Key exclusion criteria (1 listed)
- incomplete or insufficient information in their medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Patients undergoing bariatric surgery |
Primary outcome
Rate of Postoperative Complications
Time frame: 30 days
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.
1 secondary outcome
Long-term Weight Loss Efficacy
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesús E Ortiz Gómez, MD, PhD study director
Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.
Almino Cardoso Ramos, MD, PhD study chair
Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico.
Jaime Ponce de León Palomares, MD, PhD study chair
Obesity Goodbye Center, Tijuana 2050, Baja California, Mexico.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and Complication,Postoperative, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José A Guzmán Barba, MD, PhD (3471043237, aldogbarba@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Postoperative Complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.