ObesityNCT01554553
Longitudinal Sleeve Gastrectomy Study Comparing Posterior Crural Repair Versus No Repair
A study testing Posterior crural repair in people with Obesity, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the superiority of posterior crural repair during sleeve gastrectomy over no repair in decreasing the incidence of symptomatic and clinical reflux disease. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Posterior crural repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2012to 10 Aug 2018
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is between the ages of 21 and 65
- The subject is able to provide informed consent
- The subject is able and willing to comply with the study protocol
- Patients are will to refrain from the use of specified antacid medications such as PPIs (e.g. Nexium, Prilosec, Omeprazole, etc) or H2 blockes (e.g. Pepcid, Zantac, etc)
- The subjects meets the requirement for bariatric surgery as defined by the 1991 NIH consensus on bariatric surgery
- BMI ≥40 or BMI = 35-39 with one or more obesity-related comorbidities.
- Patients should have attempted, and failed, several structured methods of weight loss The subject is approved to have a sleeve gastrectomy
Who cannot join
- The subject is not able to provide informed consent
- The subject is not willing to comply with the study protocol
- The subject has had previous foregut (stomach) surgery
- The subject has evidence of a gastric tumor, ulcer, or other abnormalities at the time of EGD that would preclude them from having a sleeve gastrectomy
- Severe esophagitis or Barrett's esophagus will exclude them from the study
- The surgeon concludes that the patient is not a candidate for sleeve gastrectomy based on his clinical judgment
Trial locations and contacts
1 site in 1 country.
United States1 site
Minimally Invasive Surgeons of Texas (MIST), Bariatric Clinic
Houston, Texas, 77401
About this study
Official title: A Prospective Randomized Clinical Trial Comparing Patients Who Have Had Longitudinal Sleeve Gastrectomy With Posterior Crural Repair Versus Without Posterior Crural Repair
The purpose of this study is to evaluate the superiority of posterior crural repair during sleeve gastrectomy over no repair in decreasing the incidence of symptomatic and clinical reflux disease.
Read the detailed description
Longitudinal Sleeve gastrectomy is a type of Bariatric surgery where the stomach is divided vertically, reducing it to about 25% of its original size. Obesity itself is an independent risk factor for Gastroesophageal reflux disease (GERD); however it has been observed in the bariatric surgical community that many Longitudinal Sleeve Gastrectomy (LSG) patients are complaining of persisted GERD symptoms after LSG surgery. The incidence of GERD in these patients have been reported to be as high as 26%. GERD is an uncomfortable and dangerous disease, and if remains unchecked, it can cause ulcer disease, esophagitis, and even esophageal cancer. Because of this, bariatric surgeons want to reduce incidence of GERD after LSG, which led to multiple additions to the LSG procedures, which are currently being examined, namely, combined fundoplication with the sleeve, banded sleeve and a combined hiatal repair with SG. However, there have been no randomized comparative clinical trials to evaluate GERD as an endpoint after LSG.
Of all the possible solutions to treat increased reflux after LSG, mentioned previously, repairing the hiatus at the time of surgery makes the most sense physiologically. LSG dissection requires the obliteration of the left phrenoesophageal ligaments that hold the GE junction in place. This essentially creates a weakness in the hiatus that can lead to hiatal hernia and subsequent reflux disease. Crural repair at the time of surgery strengthens the GE junction and reduces the possibility of hiatal hernia formation. Closing the crus around the esophagus may prevent the sleeve from herniating into the chest and reduces the occurrence of reflux by repositioning the GE junction into it0s normal location in the abdomen.
- Conditions
- Obesity
- Being tested
- Posterior crural repair
- Keywords
- Sleeve gastrectomy, Posterior crural repair
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior crural repairProcedure or surgery
Also called gastric sleeve with crural repair
All patients receive gastrectomy, however patients randomized to the experimental arm will also receive posterior crural repair to determine if this will reduce GERD post sleeve gastrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Posterior crural repair | Experimental | Not described Receives: Procedure: Posterior crural repair |
| No posteriorcrural repair | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GERD / GSRS Quality of Life Questionnaire
The primary outcome of the study will be the patients' self-assessment of their reflux symptoms as reported with the GSRS quality of life questionnaire that was specifically designed to be used as an outcome measure in clinical trials of intervention in GERD. The final primary outcome will be measured every year to assess allieviation or change of reflux sysmtpms over time and to ensure there is no reoccurence of symptoms.
Measured: 1 questionnaire pre-operatively, and then every 3 months for the 1st year, every 6 months until the third year, and every 12 months until 6 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study start1 Jan 2012
- Primary completion10 Aug 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brad Snyder, The University of Texas Health Science Center, Houston
- Investigators
- Brad Snyder, MD, Principal investigator, UT Medical School at Houston, Dept. of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554553
- Sponsor's protocol ID
- HSC-MS-11-0605
- Status last verified
- May 2023
- First submitted
- 24 Feb 2012
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial Comparing Patients Who Have Had Longitudinal Sleeve Gastrectomy With Posterior Crural Repair Versus Without Posterior Crural Repair
- ClinicalTrials.gov ID
- NCT01554553
- Acronym / sponsor ID
- HSC-MS-11-0605
- Conditions
- Obesity
- Keywords
- Sleeve gastrectomy, Posterior crural repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 15 Mar 2012 (estimated)
- 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 purpose of this study is to evaluate the superiority of posterior crural repair during sleeve gastrectomy over no repair in decreasing the incidence of symptomatic and clinical reflux disease.
Detailed description
Longitudinal Sleeve gastrectomy is a type of Bariatric surgery where the stomach is divided vertically, reducing it to about 25% of its original size. Obesity itself is an independent risk factor for Gastroesophageal reflux disease (GERD); however it has been observed in the bariatric surgical community that many Longitudinal Sleeve Gastrectomy (LSG) patients are complaining of persisted GERD symptoms after LSG surgery. The incidence of GERD in these patients have been reported to be as high as 26%. GERD is an uncomfortable and dangerous disease, and if remains unchecked, it can cause ulcer disease, esophagitis, and even esophageal cancer. Because of this, bariatric surgeons want to reduce incidence of GERD after LSG, which led to multiple additions to the LSG procedures, which are currently being examined, namely, combined fundoplication with the sleeve, banded sleeve and a combined hiatal repair with SG. However, there have been no randomized comparative clinical trials to evaluate GERD as an endpoint after LSG.
Of all the possible solutions to treat increased reflux after LSG, mentioned previously, repairing the hiatus at the time of surgery makes the most sense physiologically. LSG dissection requires the obliteration of the left phrenoesophageal ligaments that hold the GE junction in place. This essentially creates a weakness in the hiatus that can lead to hiatal hernia and subsequent reflux disease. Crural repair at the time of surgery strengthens the GE junction and reduces the possibility of hiatal hernia formation. Closing the crus around the esophagus may prevent the sleeve from herniating into the chest and reduces the occurrence of reflux by repositioning the GE junction into it0s normal location in the abdomen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior crural repair | Experimental | Procedure: Posterior crural repair |
| No posteriorcrural repair | No intervention | – |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject is between the ages of 21 and 65
- The subject is able to provide informed consent
- The subject is able and willing to comply with the study protocol
- Patients are will to refrain from the use of specified antacid medications such as PPIs (e.g. Nexium, Prilosec, Omeprazole, etc) or H2 blockes (e.g. Pepcid, Zantac, etc)
- The subjects meets the requirement for bariatric surgery as defined by the 1991 NIH consensus on bariatric surgery
Key exclusion criteria (6 listed)
- The subject is not able to provide informed consent
- The subject is not willing to comply with the study protocol
- The subject has had previous foregut (stomach) surgery
- The subject has evidence of a gastric tumor, ulcer, or other abnormalities at the time of EGD that would preclude them from having a sleeve gastrectomy
- Severe esophagitis or Barrett's esophagus will exclude them from the study
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 |
|---|---|---|
| Posterior crural repairAlso: gastric sleeve with crural repairAll patients receive gastrectomy, however patients randomized to the experimental arm will also receive posterior crural repair to determine if this will reduce GERD post sleeve gastrectomy. | Procedure or surgery | Posterior crural repair |
Primary outcome
Change in GERD / GSRS Quality of Life Questionnaire
Time frame: 1 questionnaire pre-operatively, and then every 3 months for the 1st year, every 6 months until the third year, and every 12 months until 6 years.
The primary outcome of the study will be the patients' self-assessment of their reflux symptoms as reported with the GSRS quality of life questionnaire that was specifically designed to be used as an outcome measure in clinical trials of intervention in GERD. The final primary outcome will be measured every year to assess allieviation or change of reflux sysmtpms over time and to ensure there is no reoccurence of symptoms.
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 25 May 2023.
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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.
Brad Snyder, MD principal investigator
UT Medical School at Houston, Dept. of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior crural repair in people with Obesity, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 7 inclusion and 6 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 25 May 2023. 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 United States. 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?
Change in GERD / GSRS Quality of Life Questionnaire (time frame: 1 questionnaire pre-operatively, and then every 3 months for the 1st year, every 6 months until the third year, and every 12 months until 6 years.). 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 25 May 2023.