Bariatric Surgery CandidateNCT03210207
Gastric Plication in Mexican Patients
An observational study of Bariatric Surgery Candidate and Weight Loss, run by Instituto Mexicano del Seguro Social.
Trial summary
Between January and December 2012, a total of 40 patients underwent GLP. The study will assess subject excess weight loss (%EWL) following the study procedure at 3, 6, 12, 36 and 60 months. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Bariatric Surgery Candidate, Weight Loss, Obesity, Morbid
- What is being tested?
- GASTROPLICATURE
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Apr 2017
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Mexican patients who underwent Gastroplicature
Who may be able to join
- Subject is willing to give consent and comply with evaluation and treatment schedule for female patients, this includes agreement to use a reliable (per investigator) form of birth control for the duration of the trial)
- 18 to 50 years
- Subject meets ASMBS and NIH criteria: (consensus.nih.gov)
- BMI ³ 40 kg/m2 and £ 50 kg/m2; or, BMI 35-40 kg/m2 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss, including:
- Hyperlipidemia
- Mild obstructive sleep apnea (per Investigator discretion)
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- Hypertension
- Osteoarthritis of the hip or knee per investigational site's criteria for which the subject is being treated;
- ASA Class I - III;
- Agree to refrain from any type of weight-loss drug (prescription or OTC) or elective procedure that would affect body weight for the duration of the trial;
- HbA1C < 11%; and
- For subjects who have Type 2 diabetes, medication regimen is no more complex (2 oral medications) than oral metformin plus one oral sulfonylurea plus once daily insulin injection.
Who cannot join
- Documented history of drug and/or alcohol abuse within two (2) years of the Screening Visit;
- Previous malabsorptive or restrictive procedures performed for the treatment of obesity;
- Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy;
- Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
- Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring > 2 medications, or history of suicide attempts;
- Participation in any other investigational device or drug study (non-survey based trial; long-term enrollment in such studies as requiring periodic laboratory tests, etc., would be allowed) within 12 weeks of enrollment
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- Any condition which precludes compliance with the study, including:
- Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's disease or ulcerative colitis that have been active within the past 10 years;
- Congenital or acquired anomalies of the GI tract, including atresias or stenosis;
- Severe cardiopulmonary disease or other serious organic disease that makes the subject a high-risk surgical candidate;
- Uncontrolled hypertension;
- Portal hypertension;
- Chronic or acute upper gastrointestinal bleeding conditions (e.g., gastric or esophageal varices);
- Cirrhosis;
- Congenital or acquired intestinal telangiectasia;
- Esophageal or gastric disorders including moderate severe preoperative reflux, dysmotility, or Barrett's esophagus;
- Presence of hiatal hernia greater than 2cm in length, with the exception of a small sliding hiatal hernia previously undiagnosed and discovered during the surgical procedure;
- Prior surgery of the foregut including hiatal hernia repair or prior gastric surgery;
- Known history of clotting disorders, hemoglobinopathies, and hemolytic disorders, including pulmonary embolus and Deep Vein Thrombosis;
- Pancreatitis;
- Gallstones (confirmed via ultrasound);
- Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;
- Use of thiazolidinediones ("glitazones"), or Conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study;
- History or presence of pre-existing autoimmune connective tissue disease;
- Use of prescription or over the counter weight reduction medications or supplements within thirty days of the Screening Visit or the duration of study participation.
About this study
Official title: Laparoscopic Gastric Plication: 5 Years of Follow-up in Mexican Patients
Between January and December 2012, a total of 40 patients underwent GLP. The study will assess subject excess weight loss (%EWL) following the study procedure at 3, 6, 12, 36 and 60 months.
Read the detailed description
The patient characteristics extracted from the medical records included age and gender. A detailed height and weight history was collected to reflect BMI, excess weight, %EWL, and %BMI before LGP and after 3, 6, 12, 36 and 60 months.
The institutional review board approved the present study.
- Conditions
- Bariatric Surgery Candidate, Weight Loss, Obesity, Morbid
- Being tested
- GASTROPLICATURE
- Medical subject headings
- Weight Loss, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GASTROPLICATUREProcedure or surgery
All procedures were performed by a single surgeon. All patients underwent 2-row gastric plication. Dissection was started at the greater curvature of the stomach in contact to the gastric wall from prepyloric area to 2-cm proximal to the Hiss angle preserving the anatomy of Hiss angle. All vessels along the greater curvature were separated using LigaSure (Covidien, Mansfield, MA, USA). The greater curvature (from the perimeter) was invaginated using 2 rows of 00 prolene or 00 nylon sutures. Two layers of plication were performed with continuous sutures with 1 surgical sting in all patients to prevent any displacement of inverted folds such as eversion outside or intussusception into esophagus or pylorus. All sutures were extramucusal to avoid their absorption by gastric acid. Finally, a tube shaped stomach was achieved in which the greater curvature was inverted in to the stomach.
| Study group | Role | What they receive |
|---|---|---|
| GASTROPLICATURE | The procedure begins with division of the greater curve vessels from 4 to 5 cm proximal to the pylorus to the angle of His. Either ultrasonic energy or bipolar cautery is appropriate for this step.
The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.
At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum Receives: Procedure: GASTROPLICATURE |
What is being measured
The primary outcome is the main question the study is designed to answer.
excess weight loss (%EWL)
Measured: 3 postoperative months
weight loss
Measured: 3 postoperative months
BMI loss
Measured: 3 postoperative months
excess of BMI loss (%BMI)
Measured: 3 postoperative months
%EWL
Measured: 6 postoperative months
%EWL
Measured: 12 postoperative months
%EWL
Measured: 36 postoperative months
%EWL
Measured: 60 postoperative months
weight loss
Measured: 6 postoperative months
weight loss
Measured: 12 postoperative months
weight loss
Measured: 36 postoperative months
weight loss
Measured: 60 postoperative months
BMI loss
Measured: 6 postoperative months
BMI loss
Measured: 12 postoperative months
BMI loss
Measured: 36 postoperative months
BMI loss
Measured: 60 postoperative months
%BMI
Measured: 6 postoperative months
%BMI
Measured: 12 postoperative months
%BMI
Measured: 36 postoperative months
%BMI
Measured: 60 postoperative months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study startSep 2016
- Primary completionMar 2017
- Study completionApr 2017
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alejandro Gonzalez-Ojeda, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210207
- Sponsor's protocol ID
- gastroplicature-2017
- Status last verified
- Jul 2017
- First submitted
- 27 Jun 2017
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Gastric Plication: 5 Years of Follow-up in Mexican Patients
- ClinicalTrials.gov ID
- NCT03210207
- Acronym / sponsor ID
- gastroplicature-2017
- Conditions
- Bariatric Surgery Candidate, Weight Loss, Obesity, Morbid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 6 Jul 2017 (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.
Between January and December 2012, a total of 40 patients underwent GLP. The study will assess subject excess weight loss (%EWL) following the study procedure at 3, 6, 12, 36 and 60 months.
Detailed description
The patient characteristics extracted from the medical records included age and gender. A detailed height and weight history was collected to reflect BMI, excess weight, %EWL, and %BMI before LGP and after 3, 6, 12, 36 and 60 months.
The institutional review board approved the present study.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GASTROPLICATURE | – | Procedure: GASTROPLICATUREThe procedure begins with division of the greater curve vessels from 4 to 5 cm proximal to the pylorus to the angle of His. Either ultrasonic energy or bipolar cautery is appropriate for this step. The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected. At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Mexican patients who underwent Gastroplicature
Key inclusion criteria (12 listed)
- Subject is willing to give consent and comply with evaluation and treatment schedule for female patients, this includes agreement to use a reliable (per investigator) form of birth control for the duration of the trial)
- 18 to 50 years
- Subject meets ASMBS and NIH criteria: (consensus.nih.gov)
- BMI ³ 40 kg/m2 and £ 50 kg/m2; or, BMI 35-40 kg/m2 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss, including:
- Hyperlipidemia
Key exclusion criteria (25 listed)
- Documented history of drug and/or alcohol abuse within two (2) years of the Screening Visit;
- Previous malabsorptive or restrictive procedures performed for the treatment of obesity;
- Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy;
- Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
- Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring > 2 medications, or history of suicide attempts;
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 |
|---|---|---|
| GASTROPLICATUREAll procedures were performed by a single surgeon. All patients underwent 2-row gastric plication. Dissection was started at the greater curvature of the stomach in contact to the gastric wall from prepyloric area to 2-cm proximal to the Hiss angle preserving the anatomy of Hiss angle. All vessels along the greater curvature were separated using LigaSure (Covidien, Mansfield, MA, USA). The greater curvature (from the perimeter) was invaginated using 2 rows of 00 prolene or 00 nylon sutures. Two layers of plication were performed with continuous sutures with 1 surgical sting in all patients to prevent any displacement of inverted folds such as eversion outside or intussusception into esophagus or pylorus. All sutures were extramucusal to avoid their absorption by gastric acid. Finally, a tube shaped stomach was achieved in which the greater curvature was inverted in to the stomach. | Procedure or surgery | GASTROPLICATURE |
Primary outcome
excess weight loss (%EWL)
Time frame: 3 postoperative months
weight loss
Time frame: 3 postoperative months
BMI loss
Time frame: 3 postoperative months
excess of BMI loss (%BMI)
Time frame: 3 postoperative months
%EWL
Time frame: 6 postoperative months
%EWL
Time frame: 12 postoperative months
%EWL
Time frame: 36 postoperative months
%EWL
Time frame: 60 postoperative months
weight loss
Time frame: 6 postoperative months
weight loss
Time frame: 12 postoperative months
weight loss
Time frame: 36 postoperative months
weight loss
Time frame: 60 postoperative months
BMI loss
Time frame: 6 postoperative months
BMI loss
Time frame: 12 postoperative months
BMI loss
Time frame: 36 postoperative months
BMI loss
Time frame: 60 postoperative months
%BMI
Time frame: 6 postoperative months
%BMI
Time frame: 12 postoperative months
%BMI
Time frame: 36 postoperative months
%BMI
Time frame: 60 postoperative months
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 12 Jul 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and Weight Loss, run by Instituto Mexicano del Seguro Social.
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 12 inclusion and 25 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 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
excess weight loss (%EWL) (time frame: 3 postoperative months). The study lists 20 primary outcomes in all. 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 12 Jul 2017.