Postgastrectomy SyndromesNCT06316167
Mandatory Hiatoplasty in Sleeve Gastrectomy for Gastro-Esophageal Reflux Disease
An observational study of Postgastrectomy Syndromes and Gastroesophageal Reflux, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
The goal of this observational study is to learn about incidence of postoperative gastroesophageal reflux disease in mandatory hiatoplasty performed during gastric sleeve surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postgastrectomy Syndromes, Gastroesophageal Reflux
- How many people
- 275 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2024to 31 Aug 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: Patients over 18 years of age of indistinct gender who underwent gastric sleeve with hiatoplasty for obesity or overweight management in a hospital center specialized in bariatric surgery in Tijuana, Baja California.
Who may be able to join
- Patients over 18 years of age.
- Gender indistinct.
- Overweight, obesity grade I, II, III, super obesity or super-super obesity.
- Underwent gastric sleeve with hiatoplasty for obesity management at a high volume Tijuana hospital dedicated to bariatric surgery.
Who cannot join
- Patient records with incomplete information.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, Mexico
Guadalajara, Jalisco, 44329
Alejandro González-Ojeda, MD, PhD, 3331294165, avygail5@gmail.com
About this study
Official title: Implementation of Mandatory Hiatoplasty in Sleeve Gastrectomy: Strategy for Gastro-Esophageal Reflux Disease (GERD) Risk Reduction
The goal of this observational study is to learn about incidence of postoperative gastroesophageal reflux disease in mandatory hiatoplasty performed during gastric sleeve surgery.
The main question[s] it aims to answer are:
- Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty
- Comparison of postoperative complication rates, including GERD
Participants will answer a follow-up questionnaire, about postoperative quality of life
- Conditions
- Postgastrectomy Syndromes, Gastroesophageal Reflux
- Keywords
- Incidence, Complications, Bariatric surgery, Obesity
- Medical subject headings
- Postgastrectomy Syndromes, Gastroesophageal Reflux, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants without postoperative GERD
To evaluate the efficacy of mandatory hiatoplasty performed during gastric sleeve surgery in reducing the incidence of postoperative gastroesophageal reflux disease (GERD) in patients undergoing this procedure in a hospital specializing in bariatric surgery in Tijuana, Baja California.
Measured: 6 months
Secondary outcomes (4)
Comorbidities in patients undergoing gastric sleeve with hiatoplasty
These patients usually have significant obesity, often accompanied by comorbidities such as type 2 diabetes, hypertension, sleep apnea, and gastroesophageal reflux disease (GERD).
Measured: 6 months
Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty
Hiatoplasty is often performed to reduce the risk of postoperative GERD by repairing a herniated hiatus during gastric sleeve surgery. However, the exact incidence of postoperative GERD can vary and depends on factors such as surgical technique, patient anatomy and postoperative management.
Measured: 6 months
Comparison of postoperative complication rates, including GERD
Postoperative complications may include, but are not limited to, bleeding, infection, sleeve stenosis, and GERD recurrence. Comparison of complication rates between patients with and without mandatory hiatoplasty may provide insight into the effectiveness of this technique in mitigating specific risks.
Measured: 6 months
Postoperative quality of life analysis
Questionnaire postoperative quality of life with the Bariatric Analysis and Reporting Outcome System (BAROS) Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Mar 2024
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postgastrectomy SyndromesStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 275 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
- José Aldo Guzmán-Barba, MD, PhD, Study chair, ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.Alejandro López-Ortega, MD, PhD, Study director, ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.Helmut Heribert, MD, PhD, Principal investigator, ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.Isaac Esparza Estrada, MD, PhD, Study chair, ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.Sergio Jiram Vazquez-Sánchez, MD, Study chair, Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, MexicoAlejandro González-Ojeda, MD, PhD, Study chair, Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316167
- Sponsor's protocol ID
- Hiatoplasty-2024
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be kept absolutely confidential
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Mandatory Hiatoplasty in Sleeve Gastrectomy: Strategy for Gastro-Esophageal Reflux Disease (GERD) Risk Reduction
- ClinicalTrials.gov ID
- NCT06316167
- Acronym / sponsor ID
- Hiatoplasty-2024
- Conditions
- Postgastrectomy Syndromes, Gastroesophageal Reflux
- Keywords
- Incidence, Complications, Bariatric surgery, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 18 Mar 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.
The goal of this observational study is to learn about incidence of postoperative gastroesophageal reflux disease in mandatory hiatoplasty performed during gastric sleeve surgery.
The main question[s] it aims to answer are:
- Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty
- Comparison of postoperative complication rates, including GERD
Participants will answer a follow-up questionnaire, about postoperative quality of life
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age of indistinct gender who underwent gastric sleeve with hiatoplasty for obesity or overweight management in a hospital center specialized in bariatric surgery in Tijuana, Baja California.
Key inclusion criteria (4 listed)
- Patients over 18 years of age.
- Gender indistinct.
- Overweight, obesity grade I, II, III, super obesity or super-super obesity.
- Underwent gastric sleeve with hiatoplasty for obesity management at a high volume Tijuana hospital dedicated to bariatric surgery.
Key exclusion criteria (1 listed)
- Patient records with incomplete information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants without postoperative GERD
Time frame: 6 months
To evaluate the efficacy of mandatory hiatoplasty performed during gastric sleeve surgery in reducing the incidence of postoperative gastroesophageal reflux disease (GERD) in patients undergoing this procedure in a hospital specializing in bariatric surgery in Tijuana, Baja California.
4 secondary outcomes
Comorbidities in patients undergoing gastric sleeve with hiatoplasty
Time frame: 6 months
Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty
Time frame: 6 months
Comparison of postoperative complication rates, including GERD
Time frame: 6 months
Postoperative quality of life analysis
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No. Data will be kept absolutely confidential
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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.
José Aldo Guzmán-Barba, MD, PhD study chair
ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.
Alejandro López-Ortega, MD, PhD study director
ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.
Helmut Heribert, MD, PhD principal investigator
ALO Bariatrics. Gobernador Ibarra 9721, Zona Cacho, 22044, Tijuana, Baja California, México.
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 Postgastrectomy Syndromes and Gastroesophageal Reflux, 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 4 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 Mar 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 Alejandro Gonzalez-Ojeda, MD, PhD (3331294165, avygail5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants without postoperative GERD (time frame: 6 months). 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 Mar 2024.