Laparoscopic Sleeve Gastrectomy: a Cohort Study

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

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Sleeve Gastrectomy
• Intervention / Treatment: Procedure: 4-6cm from starting point of gastrectomy to pylorus; Procedure: 2-4cm from starting point of gastrectomy to pylorus

• Study Type: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise male and non-pregnant female patients, aged 16-65years both inclusive, with morbid obesity.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group1: 4-6cm; 4-6cm from starting point of gastrectomy to pylorus	Procedure: 4-6cm from starting point of gastrectomy to pylorus; The starting point of gastrectomy of the distance from the pylorus is 4-6cm during operative.
Group2: 2-4cm; 2-4cm from starting point of gastrectomy to pylorus	Procedure: 2-4cm from starting point of gastrectomy to pylorus; The starting point of gastrectomy of the distance from the pylorus is 2-4cm during operative.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Peking Union Medical College Hospital; Beijing Tiantan Hospital; Beijing Hospital; Beijing Shijitan Hospital, Capital Medical University

Publications and helpful links

General Publications

• Chow, S.C.; Shao, J.; Wang, H. 2003. Sample Size Calculations in Clinical Research. Marcel Dekker. New York.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Actual): March 28, 2020
• Study Completion (Actual): April 20, 2020

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: metabolic surgery; laparoscopic sleeve gastrectomy
• Other Study ID Numbers: BFH-LSG 01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No