Surgical Procedure, UnspecifiedNCT06396832
Comparing Post-Surgical Symptoms: Gastric Sleeve With and Without Omentopexy "Comparing Post-Surgical Symptoms: Gastric Sleeve With and Without Omentopexy" Comparison of Postoperative Symptoms: Gastric Sleeve With and Without Omentopexy.
An observational study of Surgical Procedure, Unspecified, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
Metabolic surgery has proven to be an effective treatment for obesity, with laparoscopic sleeve gastrectomy being the most popular procedure. Omentopexy (OP) is proposed as a strategy to reduce associated complications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Procedure, Unspecified
- How many people
- 53 participants
- Where
- 1 siteMexico
- Study dates
- 1 May 2022to 1 Apr 2024
- How long will I take part?
- 1 Month
- 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 diagnosed with obesity who underwent sleeve gastrectomy, with or without omentopexy
Who may be able to join
- Diagnosis of obesity
- Adults over 18 years old
- Undergoing sleeve gastrectomy
- Consent to respond to the immediate postoperative symptom questionnaire
Who cannot join
- Repair of hiatal hernia
- Refusal to complete the evaluation instrument
- Unavailability of medical records
Trial locations and contacts
1 site in 1 country.
Mexico1 site
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
About this study
Official title: POST-SURGICAL SYMPTOMS IN PATIENTS UNDERGOING GASTRIC SLEEVE SURGERY: OMENTOPEXY VS. NO OMENTOPEXY
Metabolic surgery has proven to be an effective treatment for obesity, with laparoscopic sleeve gastrectomy being the most popular procedure. Omentopexy (OP) is proposed as a strategy to reduce associated complications. Objective was to determine the effectiveness of omentopexy in controlling post-surgical symptoms and to measure the need for re-intervention, leakage, bleeding, and mortality in patients undergoing laparoscopic sleeve gastrectomy.
Read the detailed description
Patients who underwent laparoscopic sleeve gastrectomy (LSG). Of these patients, 53 received LSG with omentopexy (OP) and 52 underwent LSG without omentopexy (NO OP) between 2022 and 2023. Each group was attended by a different surgeon. The analysis focused on data concerning gastrointestinal symptoms recorded 24 hours postoperatively, as well as documented cases of bleeding, leakage, re-operation, and mortality during the hospitalization period
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- Omentopexy, Complications, Metabolic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing gastric sleeve surgery with omentopexy | Omentopexy aims to prevent or reverse sleeve gastrectomy complications, but it is not a standardized technique by itself, with more than 5 descriptions of it. Among the authors who have presented their technique are Sharma, Batman, Pilone, Abou Ashour, Nosrati, and Labib. It consists of fixing the remnant stomach with the gastrosplenic and gastrophrenic ligaments to stabilize the posterior aspect of the stomach and prevent gastric torsion, a functional cause of stenosis | |
| Patients undergoing conventional sleeve gastrectomy | The procedure is associated with other complications, some of which are believed to be related to loss of fixation of the stomach to the greater omentum. Among the main ones is nausea, exacerbation or onset of symptoms due to reflux, as well as intolerance to certain foods and regurgitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative gastrointestinal symptoms
patients undergoing sleeve gastrectomy with omentopexy for obesity treatment will be lower compared to those undergoing sleeve gastrectomy without adjuncts.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 May 2022
- Primary completion1 Feb 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies 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
- Cross-sectional
- Enrolment
- 53 participants (actual)
- Target duration
- 1 Month
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396832
- Sponsor's protocol ID
- OMENTOPEXY-2024
- Status last verified
- Apr 2024
- First submitted
- 30 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POST-SURGICAL SYMPTOMS IN PATIENTS UNDERGOING GASTRIC SLEEVE SURGERY: OMENTOPEXY VS. NO OMENTOPEXY
- ClinicalTrials.gov ID
- NCT06396832
- Acronym / sponsor ID
- OMENTOPEXY-2024
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- Omentopexy, Complications, Metabolic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 2 May 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.
Metabolic surgery has proven to be an effective treatment for obesity, with laparoscopic sleeve gastrectomy being the most popular procedure. Omentopexy (OP) is proposed as a strategy to reduce associated complications. Objective was to determine the effectiveness of omentopexy in controlling post-surgical symptoms and to measure the need for re-intervention, leakage, bleeding, and mortality in patients undergoing laparoscopic sleeve gastrectomy.
Detailed description
Patients who underwent laparoscopic sleeve gastrectomy (LSG). Of these patients, 53 received LSG with omentopexy (OP) and 52 underwent LSG without omentopexy (NO OP) between 2022 and 2023. Each group was attended by a different surgeon. The analysis focused on data concerning gastrointestinal symptoms recorded 24 hours postoperatively, as well as documented cases of bleeding, leakage, re-operation, and mortality during the hospitalization period
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing gastric sleeve surgery with omentopexy | – | –Omentopexy aims to prevent or reverse sleeve gastrectomy complications, but it is not a standardized technique by itself, with more than 5 descriptions of it. Among the authors who have presented their technique are Sharma, Batman, Pilone, Abou Ashour, Nosrati, and Labib. It consists of fixing the remnant stomach with the gastrosplenic and gastrophrenic ligaments to stabilize the posterior aspect of the stomach and prevent gastric torsion, a functional cause of stenosis |
| Patients undergoing conventional sleeve gastrectomy | – | –The procedure is associated with other complications, some of which are believed to be related to loss of fixation of the stomach to the greater omentum. Among the main ones is nausea, exacerbation or onset of symptoms due to reflux, as well as intolerance to certain foods and regurgitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with obesity who underwent sleeve gastrectomy, with or without omentopexy
Key inclusion criteria (4 listed)
- Diagnosis of obesity
- Adults over 18 years old
- Undergoing sleeve gastrectomy
- Consent to respond to the immediate postoperative symptom questionnaire
Key exclusion criteria (3 listed)
- Repair of hiatal hernia
- Refusal to complete the evaluation instrument
- Unavailability of 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.
Primary outcome
Postoperative gastrointestinal symptoms
Time frame: 24 hours
patients undergoing sleeve gastrectomy with omentopexy for obesity treatment will be lower compared to those undergoing sleeve gastrectomy without adjuncts.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Surgical Procedure, Unspecified, 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 3 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: finished, as of the sponsor's last update on 2 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative gastrointestinal symptoms (time frame: 24 hours). 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 2 May 2024.