ObesityNCT04884074
Effect of Routine Anterior Crural Repair in De-Novo Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy
A study testing Standard Sleeve Gastrectomy plus Anterior Crural Repair in people with Obesity and Gastro Esophageal Reflux Disease, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The purpose of the study is to evaluate the superiority of anterior crural repair during sleeve gastrectomy over no repair in decreasing the incidence of gastroesophageal reflux disease. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Gastro Esophageal Reflux Disease
- What is being tested?
- Standard Sleeve Gastrectomy plus Anterior Crural Repair
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 30 Dec 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject without previous bariatric procedure and meets IFSO Asia-Pacific Chapter Consensus of Metabolic \& Bariatric surgery criteria:
- BMI more than 35 kg/m2 with or without co-morbidities. ii. BMI more than 30 kg/m2 with obesity related co-morbidities.
- Subject without evidence of gastroesophageal reflux disease i. Symptomatic - No gastroesophageal reflux symptom (GerdQ score no greater than 7) ii. Endoscopic - No esophagitis. No Hiatus Hernia (apparent separation distance between the squamocolumnar junction and the diaphragmatic impression greater than 2 cm) iii. Functional
- 1. High-resolution manometry 2. 24-hour esophageal pH study 4. ASA Class I - III 5. Subject is willing to give consent and comply with evaluation and treatment scheduled
Who cannot join
- Pre-existing GERD, evident symptomatically, endoscopically or upon functional testing
- Presence of Hiatus hernia (>2cm) or esophagitis
- Previous upper GI surgery (e.g. bariatric surgery, anti-reflux surgery; gastrectomy; esophageal surgery)
- Underlying uncontrolled endocrine problem that lead to obesity. (e.g. Hypothyroidism, Cushing syndrome, eating disorder etc)
- ASA grade IV \& V
- Mental or psychiatric disorder; Drug or alcohol addiction
Show all 14Show fewer
- Cirrhosis or portal hypertension
- Pregnant or breast feeding
- Any condition which precludes compliance with the study;
- History or presence of pre-existing autoimmune connective tissue disease
- Active malignant disease. Patients with malignant disease who have been disease-free for at least 5 years are eligible
- Active infection
- Life expectancy less than 12 months
- Special population, e.g. prisoner, mentally disabled, investigators' student or employees
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese University of Hong Kong
Hong Kong
Enders Ng, MD, +852 26322956, endersng@surgery.cuhk.edu.hk
About this study
Official title: Effect of Routine Anterior Crural Repair in De-Novo Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy - A Randomized Control Trial
The purpose of the study is to evaluate the superiority of anterior crural repair during sleeve gastrectomy over no repair in decreasing the incidence of gastroesophageal reflux disease.
Read the detailed description
Introduction Obesity is a global pandemic. The prevalence of overweight and obesity is increasing globally. Together with its co-morbidities, obesity substantially decreased quality of life and life expectancy. Bariatric surgery has been shown to provide substantial and sustained effects on weight loss and ameliorates obesity-related comorbidities. Among different bariatric procedures, laparoscopic sleeve gastrectomy (LSG) is increasingly being performed due to the favorable bariatric outcome, simplicity of the procedure and relatively low complication profile as compared to bypass procedure.
Development of gastroesophageal reflux disease (GERD is a major health concern after LSG. It has been observed in the bariatric surgical community that many patients are complaining of persisted GERD symptoms after LSG surgery.
Aiming to avoid post-operative GERD, hiatal dissection with crural repair had been suggested to be performed on top of the sleeve gastrectomy procedure.
Data Collection Baseline data collection: All potential candidates will be screened for secondary causes of obesity, such as hypothyroidism and Cushing's syndrome, and are assessed for severity of obesity-related diseases including hypertension, diabetes mellitus, obstructive sleep apnoea syndrome and hyperlipidaemia. Extensive counseling will be given and potential benefits and complications of treatments will be discussed with all participants at least 4 weeks prior to recruitment.
Procedure data: Operative time, blood loss and total hospital stay are captured prospectively. All peri-operative complications will be documented and graded according to the Clavien-Dindo Classification System to facilitate comparison.
Follow-up and assessment:
Patients will be followed up at a designated Multi-disciplinary Clinic of Metabolic and Bariatric Surgery at 4 weeks, 3 months, 6 months, 9 months and 1 year after the operation. A standard dietary and exercise regimen will be prescribed to the patients, and their compliance to the life-style modification is monitored by designated dietitians. Counselling will be provided whenever necessary.
They are assessed for symptomatology according to a standard checklist by independent assessors who are blind to the mode of surgery performed. Data collection and blood tests, endoscopy and esophageal function test (see below) will be carried out during clinic visits.
Adherence to Good Clinical Practices (GCPs) This trial will reference the international ethical principles endorsed by the World Medical Association Declaration of Helsinki as well as ICH/GCP Standards, and any other applicable local laws or regulations
Data Completion and Record Keeping The hard-copy of patients' medical records will be kept in the Prince of Wales Hospital and the electronic information regarding patient information will be stored in the University/Hospital computer and password encrypted. Only the principle investigator, co-investigator and the research nurse will have the right to access these data. Data will be stored for 5 years and after completion of study, both hard \& soft copy of the patients \& study data will be destroyed and deleted of a body function or damage to a body structure.
- Conditions
- Obesity, Gastro Esophageal Reflux Disease
- Being tested
- Standard Sleeve Gastrectomy plus Anterior Crural Repair, Standard sleeve gastrectomy (SSG, the control group)
- Keywords
- Obesity, Gastro Esophageal Reflux Disease, Laparoscopic Sleeve Gastrectomy, Anterior Crural Repair
- Medical subject headings
- Obesity, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Sleeve Gastrectomy plus Anterior Crural RepairProcedure or surgery
The procedure is performed in a similar fashion as standard sleeve gastrectomy. After gastric mobilization is completed as standard sleeve gastrectomy, the anterior phrenoesophageal ligament is divided and distal 3cm esophagus is mobilized. A Mid-Sleeve tube (40Fr) is inserted per-orally by the anesthetist and the hiatus opening is closed with 2/0 non-absorbable suture over the bougie anterior to the esophagus. The hiatus repair was sized by comfortably placement a dissection forceps adjacent to the esophagus without tension. Sleeve gastrectomy is then performed as the standard technique.
Standard sleeve gastrectomy (SSG, the control group)Procedure or surgery
The procedure is performed in French position with a standard 5-port approach and a pneumoperitoneum not exceeding 15mmHg.
The greater omentum is then completely detached from the greater curvature of stomach using either ultrasonic or bipolar shear device. All adhesion between posterior gastric wall and pancreatic capsule is freed and the cardia is completely free with left crura completely exposed. A Mid-Sleeve tube (40Fr) is inserted per-orally by the anesthetist with its balloon tip reaching the gastric antrum and insufflated with 50cc of air. Sleeve gastrectomy is then performed using laparoscopic linear staplers, starting from a point 5-6cm proximal to the pylorus up cardia at about 1cm lateral to the angle of His, along the Mid-sleeve tube which is lying against the lesser curve of stomach. The staple line is reinforced with absorbable sutures. Distal stomach is anchored at retroperitoneum with non-absorbable stitch.
| Study group | Role | What they receive |
|---|---|---|
| The study group | Experimental | The procedure done to this group is Sleeve Gastrectomy with Anterior Crural Repair (ACR) Receives: Procedure: Standard Sleeve Gastrectomy plus Anterior Crural Repair |
| The control group | Other | The procedure done to this group is the Standard Sleeve Gastrectomy (SSG) Receives: Procedure: Standard sleeve gastrectomy (SSG, the control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic GERD
Defined by GerdQ score > 7
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 May 2021 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Model description
- Randomized double-blind controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enders K.W. Ng, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884074
- Sponsor's protocol ID
- CRE-2016.202
- Status last verified
- Apr 2021
- First submitted
- 7 May 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Suter M, Dorta G, Giusti V, Calmes JM. Gastro-esophageal reflux and esophageal motility disorders in morbidly obese patients. Obes Surg. 2004 Aug;14(7):959-66. doi: 10.1381/0960892041719581.
PubMed 15329186Mahawar KK, Jennings N, Balupuri S, Small PK. Sleeve gastrectomy and gastro-oesophageal reflux disease: a complex relationship. Obes Surg. 2013 Jul;23(7):987-91. doi: 10.1007/s11695-013-0899-x.
PubMed 23460263Tai CM, Huang CK. Increase in gastroesophageal reflux disease symptoms and erosive esophagitis 1 year after laparoscopic sleeve gastrectomy among obese adults. Surg Endosc. 2013 Oct;27(10):3937. doi: 10.1007/s00464-013-3022-4. Epub 2013 May 25. No abstract available.
PubMed 23708727Daes J, Jimenez ME, Said N, Dennis R. Improvement of gastroesophageal reflux symptoms after standardized laparoscopic sleeve gastrectomy. Obes Surg. 2014 Apr;24(4):536-40. doi: 10.1007/s11695-013-1117-6.
PubMed 24203681Wong SK, Lok H, Lam CC, Ng EK. Small Hiatus Hernia and Gastroesophgeal Reflux after Laparoscopic Sleeve Gastrectomy in Morbidly Obese Chinese. Obes Surg. 2014;24(8):1243.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Routine Anterior Crural Repair in De-Novo Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy - A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04884074
- Acronym / sponsor ID
- CRE-2016.202
- Conditions
- Obesity, Gastro Esophageal Reflux Disease
- Keywords
- Obesity, Gastro Esophageal Reflux Disease, Laparoscopic Sleeve Gastrectomy, Anterior Crural Repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 May 2021 (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 purpose of the study is to evaluate the superiority of anterior crural repair during sleeve gastrectomy over no repair in decreasing the incidence of gastroesophageal reflux disease.
Detailed description
Introduction Obesity is a global pandemic. The prevalence of overweight and obesity is increasing globally. Together with its co-morbidities, obesity substantially decreased quality of life and life expectancy. Bariatric surgery has been shown to provide substantial and sustained effects on weight loss and ameliorates obesity-related comorbidities. Among different bariatric procedures, laparoscopic sleeve gastrectomy (LSG) is increasingly being performed due to the favorable bariatric outcome, simplicity of the procedure and relatively low complication profile as compared to bypass procedure.
Development of gastroesophageal reflux disease (GERD is a major health concern after LSG. It has been observed in the bariatric surgical community that many patients are complaining of persisted GERD symptoms after LSG surgery.
Aiming to avoid post-operative GERD, hiatal dissection with crural repair had been suggested to be performed on top of the sleeve gastrectomy procedure.
Data Collection Baseline data collection: All potential candidates will be screened for secondary causes of obesity, such as hypothyroidism and Cushing's syndrome, and are assessed for severity of obesity-related diseases including hypertension, diabetes mellitus, obstructive sleep apnoea syndrome and hyperlipidaemia. Extensive counseling will be given and potential benefits and complications of treatments will be discussed with all participants at least 4 weeks prior to recruitment.
Procedure data: Operative time, blood loss and total hospital stay are captured prospectively. All peri-operative complications will be documented and graded according to the Clavien-Dindo Classification System to facilitate comparison.
Follow-up and assessment:
Patients will be followed up at a designated Multi-disciplinary Clinic of Metabolic and Bariatric Surgery at 4 weeks, 3 months, 6 months, 9 months and 1 year after the operation. A standard dietary and exercise regimen will be prescribed to the patients, and their compliance to the life-style modification is monitored by designated dietitians. Counselling will be provided whenever necessary.
They are assessed for symptomatology according to a standard checklist by independent assessors who are blind to the mode of surgery performed. Data collection and blood tests, endoscopy and esophageal function test (see below) will be carried out during clinic visits.
Adherence to Good Clinical Practices (GCPs) This trial will reference the international ethical principles endorsed by the World Medical Association Declaration of Helsinki as well as ICH/GCP Standards, and any other applicable local laws or regulations
Data Completion and Record Keeping The hard-copy of patients' medical records will be kept in the Prince of Wales Hospital and the electronic information regarding patient information will be stored in the University/Hospital computer and password encrypted. Only the principle investigator, co-investigator and the research nurse will have the right to access these data. Data will be stored for 5 years and after completion of study, both hard \& soft copy of the patients \& study data will be destroyed and deleted of a body function or damage to a body structure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double-blind controlled trial
| Arm | Type | Receives |
|---|---|---|
| The study group | Experimental | Procedure: Standard Sleeve Gastrectomy plus Anterior Crural RepairThe procedure done to this group is Sleeve Gastrectomy with Anterior Crural Repair (ACR) |
| The control group | Other | Procedure: Standard sleeve gastrectomy (SSG, the control group)The procedure done to this group is the Standard Sleeve Gastrectomy (SSG) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject without previous bariatric procedure and meets IFSO Asia-Pacific Chapter Consensus of Metabolic \& Bariatric surgery criteria:
- Subject without evidence of gastroesophageal reflux disease i. Symptomatic - No gastroesophageal reflux symptom (GerdQ score no greater than 7) ii. Endoscopic - No esophagitis. No Hiatus Hernia (apparent separation distance between the squamocolumnar junction and the diaphragmatic impression greater than 2 cm) iii. Functional
- 1. High-resolution manometry 2. 24-hour esophageal pH study 4. ASA Class I - III 5. Subject is willing to give consent and comply with evaluation and treatment scheduled
Key exclusion criteria (14 listed)
- Pre-existing GERD, evident symptomatically, endoscopically or upon functional testing
- Presence of Hiatus hernia (>2cm) or esophagitis
- Previous upper GI surgery (e.g. bariatric surgery, anti-reflux surgery; gastrectomy; esophageal surgery)
- Underlying uncontrolled endocrine problem that lead to obesity. (e.g. Hypothyroidism, Cushing syndrome, eating disorder etc)
- ASA grade IV \& V
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 |
|---|---|---|
| Standard Sleeve Gastrectomy plus Anterior Crural RepairThe procedure is performed in a similar fashion as standard sleeve gastrectomy. After gastric mobilization is completed as standard sleeve gastrectomy, the anterior phrenoesophageal ligament is divided and distal 3cm esophagus is mobilized. A Mid-Sleeve tube (40Fr) is inserted per-orally by the anesthetist and the hiatus opening is closed with 2/0 non-absorbable suture over the bougie anterior to the esophagus. The hiatus repair was sized by comfortably placement a dissection forceps adjacent to the esophagus without tension. Sleeve gastrectomy is then performed as the standard technique. | Procedure or surgery | The study group |
| Standard sleeve gastrectomy (SSG, the control group)The procedure is performed in French position with a standard 5-port approach and a pneumoperitoneum not exceeding 15mmHg. The greater omentum is then completely detached from the greater curvature of stomach using either ultrasonic or bipolar shear device. All adhesion between posterior gastric wall and pancreatic capsule is freed and the cardia is completely free with left crura completely exposed. A Mid-Sleeve tube (40Fr) is inserted per-orally by the anesthetist with its balloon tip reaching the gastric antrum and insufflated with 50cc of air. Sleeve gastrectomy is then performed using laparoscopic linear staplers, starting from a point 5-6cm proximal to the pylorus up cardia at about 1cm lateral to the angle of His, along the Mid-sleeve tube which is lying against the lesser curve of stomach. The staple line is reinforced with absorbable sutures. Distal stomach is anchored at retroperitoneum with non-absorbable stitch. | Procedure or surgery | The control group |
Primary outcome
Incidence of symptomatic GERD
Time frame: 1 year
Defined by GerdQ score > 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Background: PubMed 15329186Suter M, Dorta G, Giusti V, Calmes JM. Gastro-esophageal reflux and esophageal motility disorders in morbidly obese patients. Obes Surg. 2004 Aug;14(7):959-66. doi: 10.1381/0960892041719581.
- Background: PubMed 23460263Mahawar KK, Jennings N, Balupuri S, Small PK. Sleeve gastrectomy and gastro-oesophageal reflux disease: a complex relationship. Obes Surg. 2013 Jul;23(7):987-91. doi: 10.1007/s11695-013-0899-x.
- Background: PubMed 23708727Tai CM, Huang CK. Increase in gastroesophageal reflux disease symptoms and erosive esophagitis 1 year after laparoscopic sleeve gastrectomy among obese adults. Surg Endosc. 2013 Oct;27(10):3937. doi: 10.1007/s00464-013-3022-4. Epub 2013 May 25. No abstract available.
- Background: PubMed 24203681Daes J, Jimenez ME, Said N, Dennis R. Improvement of gastroesophageal reflux symptoms after standardized laparoscopic sleeve gastrectomy. Obes Surg. 2014 Apr;24(4):536-40. doi: 10.1007/s11695-013-1117-6.
- BackgroundWong SK, Lok H, Lam CC, Ng EK. Small Hiatus Hernia and Gastroesophgeal Reflux after Laparoscopic Sleeve Gastrectomy in Morbidly Obese Chinese. Obes Surg. 2014;24(8):1243.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Sleeve Gastrectomy plus Anterior Crural Repair in people with Obesity and Gastro Esophageal Reflux Disease, run by Chinese University of Hong Kong at 1 site in China.
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 14 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 12 May 2021. 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 China. 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 Enders KW Ng, Professor (55699241, endersng@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic GERD (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04884074, which also lists 5 linked publications.
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 May 2021.