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Effect of Routine Anterior Crural Repair in De-Novo Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy

Primary Purpose

Obesity, Gastro Esophageal Reflux Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Standard Sleeve Gastrectomy plus Anterior Crural Repair
Standard sleeve gastrectomy (SSG, the control group)
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Gastro Esophageal Reflux Disease, Laparoscopic Sleeve Gastrectomy, Anterior Crural Repair

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subject without previous bariatric procedure and meets IFSO Asia-Pacific Chapter Consensus of Metabolic & Bariatric surgery criteria:

    i. BMI more than 35 kg/m2 with or without co-morbidities. ii. BMI more than 30 kg/m2 with obesity related co-morbidities.

  2. 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

Exclusion Criteria:

  1. Pre-existing GERD, evident symptomatically, endoscopically or upon functional testing
  2. Presence of Hiatus hernia (>2cm) or esophagitis
  3. Previous upper GI surgery (e.g. bariatric surgery, anti-reflux surgery; gastrectomy; esophageal surgery)
  4. Underlying uncontrolled endocrine problem that lead to obesity. (e.g. Hypothyroidism, Cushing syndrome, eating disorder etc)
  5. ASA grade IV & V
  6. Mental or psychiatric disorder; Drug or alcohol addiction
  7. Cirrhosis or portal hypertension
  8. Pregnant or breast feeding
  9. Any condition which precludes compliance with the study;
  10. History or presence of pre-existing autoimmune connective tissue disease
  11. Active malignant disease. Patients with malignant disease who have been disease-free for at least 5 years are eligible
  12. Active infection
  13. Life expectancy less than 12 months
  14. Special population, e.g. prisoner, mentally disabled, investigators' student or employees

Sites / Locations

  • Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

The study group

The control group

Arm Description

The procedure done to this group is Sleeve Gastrectomy with Anterior Crural Repair (ACR)

The procedure done to this group is the Standard Sleeve Gastrectomy (SSG)

Outcomes

Primary Outcome Measures

Incidence of symptomatic GERD
Defined by GerdQ score > 7

Secondary Outcome Measures

Full Information

First Posted
May 7, 2021
Last Updated
May 7, 2021
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04884074
Brief Title
Effect of Routine Anterior Crural Repair in De-Novo Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy
Official Title
Effect of Routine Anterior Crural Repair in De-Novo Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy - A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Gastro Esophageal Reflux Disease
Keywords
Obesity, Gastro Esophageal Reflux Disease, Laparoscopic Sleeve Gastrectomy, Anterior Crural Repair

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized double-blind controlled trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The randomization is done by telephone call to the randomization centre where a dedicated research assistant without detailed knowledge of the recruited patient's background will open a sealed envelope containing a computer-generated random number which indicates the mode of intervention. Both the patients and clinical assessors (independent of the operating surgeons) are blind to the mode of intervention in the first one year of enrollment.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The study group
Arm Type
Experimental
Arm Description
The procedure done to this group is Sleeve Gastrectomy with Anterior Crural Repair (ACR)
Arm Title
The control group
Arm Type
Other
Arm Description
The procedure done to this group is the Standard Sleeve Gastrectomy (SSG)
Intervention Type
Procedure
Intervention Name(s)
Standard Sleeve Gastrectomy plus Anterior Crural Repair
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard sleeve gastrectomy (SSG, the control group)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of symptomatic GERD
Description
Defined by GerdQ score > 7
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject without previous bariatric procedure and meets IFSO Asia-Pacific Chapter Consensus of Metabolic & Bariatric surgery criteria: i. 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enders KW Ng, Professor
Phone
55699241
Email
endersng@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Simon KH Wong, Consultant
Phone
55699510
Email
wongkhmo@surgery.cuhk.edu.hk
Facility Information:
Facility Name
Chinese University of Hong Kong
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enders Ng, MD
Phone
+852 26322956
Email
endersng@surgery.cuhk.edu.hk

12. IPD Sharing Statement

Citations:
PubMed Identifier
15329186
Citation
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.
Results Reference
background
PubMed Identifier
23460263
Citation
Mahawar 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.
Results Reference
background
PubMed Identifier
23708727
Citation
Tai 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.
Results Reference
background
PubMed Identifier
24203681
Citation
Daes 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.
Results Reference
background
Citation
Wong 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.
Results Reference
background

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Effect of Routine Anterior Crural Repair in De-Novo Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy

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