GERDNCT04652336
Study Comparing the Effect of Ligamentum Teres Cardiopexy on de Novo GERD Post LSG
A study testing laparoscopic sleeve gastrectomy and ligamentum teres cardiopexy with sleeve gastrectomy in people with GERD, run by GEM Hospital & Research Center.
Trial summary
The aim of this study is to investigate the effect of ligamentum teres cardiopexy on incidence of de Novo GERD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- GERD
- What is being tested?
- laparoscopic sleeve gastrectomy and ligamentum teres cardiopexy with sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2020to 10 Dec 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- candidate for bariatric surgery according to IFSO - APC guidelines
- No evidence (objective and subjective) of GERD
Who cannot join
- Presence of GERD either by history or by 24 hr pH study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Controlled Trial Comparing the Effect of Ligamentum Teres Cardiopexy on de Novo GERD Post LSG
The aim of this study is to investigate the effect of ligamentum teres cardiopexy on incidence of de Novo GERD.
Read the detailed description
Laparoscopic Sleeve Gastrectomy (LSG) is now the most commonly performed bariatric surgery world wide. The results of LSG on outcomes of GERD are conflicting. It has been reported to increase the severity of pre existing GERD and also to cause new onset GERD in considerable number of patients.
In this study the effect of adding a novel procedure i.e. ligamentum teres cardiopexy,(LTC) to regular LSG on occurence of de Novo GERD will be investigated. de Novo GERD has been found to occur in 20% of cases post LSG.
This study is a randomized, prospective, parallel group, controlled trial to compare the effect of LSG versus LSG with LTC on occurence of de Novo GERD.
This is a single center based trial, being conducted in GEM hospital and research center, Coimbatore, Tamil Nadu, India. The trial has been approved by GEM research ethics committee.
Investigators are planning to enroll patients who are not having any objective or subjective evidence of GERD. The participants will be optimized as per institutional bariatric surgery protocol. After complete evaluation and optimization, participants will be randomized by computer generated random numbers into either LSG or LSG with LTC group.
The demographic data, preoperative GERD - Q scores, 24 hour pH study, intra operative details will be recorded. Post operative details during each follow up will be recorded, which will include excess weight loss, GERD - Q scores. At 6 months follow up repeat 24 hour pH study will be done to assess the status of GERD objectively.
The trial duration is expected to be of 1 year where in investigators will be recruiting patients for 6 months.
- Conditions
- GERD
- Being tested
- laparoscopic sleeve gastrectomy, ligamentum teres cardiopexy with sleeve gastrectomy
- Keywords
- de Novo GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic sleeve gastrectomyProcedure or surgery
Comparator arm - will receive standard laparoscopic sleeve gastrectomy
ligamentum teres cardiopexy with sleeve gastrectomyProcedure or surgery
experimental arm - Ligamentum teres will be divided from umbilicus to up to umbilical fissure. The ligament will then be wrapped around lower esophagus and sutured.
| Study group | Role | What they receive |
|---|---|---|
| LSG | Active comparator | This group will receive standard laparoscopic sleeve gastrectomy Receives: Procedure: laparoscopic sleeve gastrectomy |
| LSG with LTC | Experimental | This group will receive LSG along with the novel LTC procedure Receives: Procedure: ligamentum teres cardiopexy with sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
GERD
Subjective (Gastroesophageal Reflux Disease questionnaires - GERD - Q) and objective (24 hour pH study) measurement of occurence of GERD will be done GERD - Q - Score 0-2 denotes no GERD. Score more than or equal to 3 indicates presence of GERD 24 hr pH study - Demeester score more than 14.7 is indicative of presence of GERD
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 posted3 Dec 2020
- Study start10 Dec 2020 (estimated)
- Primary completion10 May 2021 (estimated)
- Study completion10 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GEM Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652336
- Sponsor's protocol ID
- GHC-16-OCT/2020
- Status last verified
- Dec 2020
- First submitted
- 26 Nov 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Effect of Ligamentum Teres Cardiopexy on de Novo GERD Post LSG
- ClinicalTrials.gov ID
- NCT04652336
- Acronym / sponsor ID
- GHC-16-OCT/2020
- Conditions
- GERD
- Keywords
- de Novo GERD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GEM Hospital & Research CenterUniversity, hospital or other
- Study start
- 10 Dec 2020 (estimated)
- Primary completion
- 10 May 2021 (estimated)
- Study completion
- 10 Dec 2021 (estimated)
- First posted
- 3 Dec 2020 (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 aim of this study is to investigate the effect of ligamentum teres cardiopexy on incidence of de Novo GERD.
Detailed description
Laparoscopic Sleeve Gastrectomy (LSG) is now the most commonly performed bariatric surgery world wide. The results of LSG on outcomes of GERD are conflicting. It has been reported to increase the severity of pre existing GERD and also to cause new onset GERD in considerable number of patients.
In this study the effect of adding a novel procedure i.e. ligamentum teres cardiopexy,(LTC) to regular LSG on occurence of de Novo GERD will be investigated. de Novo GERD has been found to occur in 20% of cases post LSG.
This study is a randomized, prospective, parallel group, controlled trial to compare the effect of LSG versus LSG with LTC on occurence of de Novo GERD.
This is a single center based trial, being conducted in GEM hospital and research center, Coimbatore, Tamil Nadu, India. The trial has been approved by GEM research ethics committee.
Investigators are planning to enroll patients who are not having any objective or subjective evidence of GERD. The participants will be optimized as per institutional bariatric surgery protocol. After complete evaluation and optimization, participants will be randomized by computer generated random numbers into either LSG or LSG with LTC group.
The demographic data, preoperative GERD - Q scores, 24 hour pH study, intra operative details will be recorded. Post operative details during each follow up will be recorded, which will include excess weight loss, GERD - Q scores. At 6 months follow up repeat 24 hour pH study will be done to assess the status of GERD objectively.
The trial duration is expected to be of 1 year where in investigators will be recruiting patients for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSG | Active comparator | Procedure: laparoscopic sleeve gastrectomyThis group will receive standard laparoscopic sleeve gastrectomy |
| LSG with LTC | Experimental | Procedure: ligamentum teres cardiopexy with sleeve gastrectomyThis group will receive LSG along with the novel LTC procedure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- candidate for bariatric surgery according to IFSO - APC guidelines
- No evidence (objective and subjective) of GERD
Key exclusion criteria (1 listed)
- Presence of GERD either by history or by 24 hr pH 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 |
|---|---|---|
| laparoscopic sleeve gastrectomyComparator arm - will receive standard laparoscopic sleeve gastrectomy | Procedure or surgery | LSG |
| ligamentum teres cardiopexy with sleeve gastrectomyexperimental arm - Ligamentum teres will be divided from umbilicus to up to umbilical fissure. The ligament will then be wrapped around lower esophagus and sutured. | Procedure or surgery | LSG with LTC |
Primary outcome
GERD
Time frame: 6 months
Subjective (Gastroesophageal Reflux Disease questionnaires - GERD - Q) and objective (24 hour pH study) measurement of occurence of GERD will be done GERD - Q - Score 0-2 denotes no GERD. Score more than or equal to 3 indicates presence of GERD 24 hr pH study - Demeester score more than 14.7 is indicative of presence of GERD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic sleeve gastrectomy and ligamentum teres cardiopexy with sleeve gastrectomy in people with GERD, run by GEM Hospital & Research Center.
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 21 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PRAKHAR GUPTA (+919582438389, mailto.guptaprakhar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 21 Dec 2020.