Laparoscopic Sleeve Gastrectomy: a Cohort Study
- Conditions
- Laparoscopic Sleeve Gastrectomy
- Interventions
- Procedure: 4-6cm from starting point of gastrectomy to pylorusProcedure: 2-4cm from starting point of gastrectomy to pylorus
- Registration Number
- NCT03629808
- Lead Sponsor
- Beijing Friendship Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 138
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group1: 4-6cm 4-6cm from starting point of gastrectomy to pylorus 4-6cm from starting point of gastrectomy to pylorus Group2: 2-4cm 2-4cm from starting point of gastrectomy to pylorus 2-4cm from starting point of gastrectomy to pylorus
- Primary Outcome Measures
Name Time Method The incidence rate of upper gastrointestinal symptoms after surgery 1 year 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)
- Secondary Outcome Measures
Name Time Method the rate of postoperative complications after surgery 1 year 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)The excess weight loss (%EWL) after surgery 1 year 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)The extent of upper gastrointestinal symptoms after surgery 1 year 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)
Trial Locations
- Locations (1)
Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China