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

NCT04884074 | Unknown DMC

• 1 other identifier: CRE-2016.202
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Gastro Esophageal Reflux Disease

Keywords

Obesity; Gastro Esophageal Reflux Disease; Laparoscopic Sleeve Gastrectomy; Anterior Crural Repair

Outcome Measures

Primary Outcomes (1)

• Incidence of symptomatic GERD

  Defined by GerdQ score \> 7

  1 year

Study Arms (2)

The study group

EXPERIMENTAL

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

Procedure: Standard Sleeve Gastrectomy plus Anterior Crural Repair

The control group

OTHER

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

Procedure: Standard sleeve gastrectomy (SSG, the control group)

Interventions

Standard Sleeve Gastrectomy plus Anterior Crural Repair PROCEDURE

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.

The study group

Standard sleeve gastrectomy (SSG, the control group) PROCEDURE

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.

The control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 15329186 BACKGROUND

• 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.

  PMID: 23460263 BACKGROUND

• 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.

  PMID: 23708727 BACKGROUND

• 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.

  PMID: 24203681 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Obesity; Gastroesophageal Reflux

Interventions

Antimony Sodium Gluconate

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Organic Chemicals; Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Central Study Contacts

Enders KW Ng, Professor

CONTACT

55699241; endersng@surgery.cuhk.edu.hk

Simon KH Wong, Consultant

CONTACT

55699510; wongkhmo@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized double-blind controlled trial

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 12, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 30, 2025
• Last Updated: May 12, 2021

Record last verified: 2021-04

Locations

CN (1)