Laparoscopic Sleeve Gastrectomy: a Cohort Study

Study Overview
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Brief Summary
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This is a prospective cohort study, which subjects were obese patients requiring LSG surgery. LSG with different gastric resection starting points (2-4cm/4-6 cm from pylorus) as intervention method. The main observation is the incidence and extent of upper gastrointestinal symptoms (such as nausea, vomiting, retching, reflux, difficulty swallowing, etc.).In addition, secondary observations include the excess weight loss (%EWL) and postoperative complications. Aim to investigate the effects of LSG surgery in different starting points of gastric resection on postoperative upper gastrointestinal symptoms.

Official Title
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The Effect of Residual Gastric Antrum Size During Laparoscopic Sleeve Gastrectomy in Reducing Postoperative Gastrointestinal Symptoms: a Cohort Study

Conditions
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Laparoscopic Sleeve Gastrectomy

Intervention / Treatment
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* Procedure: 4-6cm from starting point of gastrectomy to pylorus
* Procedure: 2-4cm from starting point of gastrectomy to pylorus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were accepted for surgery if they satisfied the guidelines of the Society of Chinese Gastroenterological Surgeons [body mass index (BMI) ≥40 kg/m2 or BMI ≥35 kg/m2 with at least one co-morbidity associated with obesity (type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea), age between 18 and 60 years, and failure of conservative treatment over 2 years]. All patients undergo preoperative upper gastrointestinal (GI) endoscopy. Exclusion Criteria: any patient who had previously been submitted to any type of bariatric surgery; patient currently taking anti-nausea or GERD medications preoperatively; any current smokers； active duodenal/gastric ulcer disease； difficult to treat gastroesophageal reflux disease (GERD) with a large hiatal hernia； previous major gastrointestinal surgery； diagnosed or suspected malignancy； poorly controlled significant medical or psychiatric disorders； disorders such as a medical history of major pathology; can not be able to understand and willing to participate in this registry with signature.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group1: 4-6cm<br>4-6cm from starting point of gastrectomy to pylorus | Procedure: 4-6cm from starting point of gastrectomy to pylorus<br>* The starting point of gastrectomy of the distance from the pylorus is 4-6cm during operative.<br>|
| Group2: 2-4cm<br>2-4cm from starting point of gastrectomy to pylorus | Procedure: 2-4cm from starting point of gastrectomy to pylorus<br>* The starting point of gastrectomy of the distance from the pylorus is 2-4cm during operative.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence rate of upper gastrointestinal symptoms after surgery | We use three scales to evaluate the incidence of upper gastrointestinal symptoms,include the Chinese translation of R-INVR(the Index of Nausea, Vomiting, and Retching)、EAT-10(Validity and Reliability of the Eating Assessment Tool) and GIS(GERD impact serve).These three scales describe postoperative upper gastrointestinal symptoms,which include vomiting, dysphagia,and acid reflux,heartburn.We focus on the incidence rate of the above symptoms in one year after surgery during 1 year. Visit: Post-op 12 months Visit(±7 Days) | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The excess weight loss (%EWL) after surgery | Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which ideal weight is defined by the weight corresponding to a BMI of 25 kg/m2). Visit 1: Baseline Visit (Day 0-1) Visit 2: Post-op 3 days Visit Visit 3: Post-op 7 days Visit Visit 4: Post-op 1 month Visit(±3 Days) Visit 5: Post-op 3 months Visit(±7 Days) Visit 6: Post-op 12 months Visit(±7 Days) | 1 year after surgery | 
| the rate of postoperative complications after surgery | Postoperative complications including but not limited to: 1, abdominal bleeding; 2, gastrointestinal bleeding; 3, intestinal obstruction; 4, digestive tract leakage 5, anastomotic stenosis / gastric stenosis; 6, death ,etc. Visit 1: Baseline Visit (Day 0-1) Visit 2: Post-op 3 days Visit Visit 3: Post-op 7 days Visit Visit 4: Post-op 1 month Visit(±3 Days) Visit 5: Post-op 3 months Visit(±7 Days) Visit 6: Post-op 12 months Visit(±7 Days) | 1 year after surgery | 
| The extent of upper gastrointestinal symptoms after surgery | We use three scales to evaluate the incidence of upper gastrointestinal symptoms,include the Chinese translation of R-INVR(the Index of Nausea, Vomiting, and Retching)、EAT-10(Validity and Reliability of the Eating Assessment Tool) and GIS(GERD impact serve).These three scales quantify the degree of vomiting, difficulty swallowing, acid reflux, heartburn, etc.We will calculate the extent of the above upper gastrointestinal symptoms at five time points in one year after surgery. Visit 1: Post-op 3 days Visit Visit 2: Post-op 7 days Visit Visit 3: Post-op 1 month Visit(±3 Days) Visit 4: Post-op 3 months Visit(±7 Days) Visit 5: Post-op 12 months Visit(±7 Days) | 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic surgery, laparoscopic sleeve gastrectomy