Laparoscopic Sleeve Gastrectomy: a Cohort Study

Laparoscopic Sleeve Gastrectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03629808
• Other study ID #: BFH-LSG 01
• Status: Completed
• Start date: July 10, 2018
• Est. completion date: April 20, 2020

Study information

• Verified date: April 2020
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: April 20, 2020
• Est. primary completion date: March 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Sleeve Gastrectomy

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Beijing Hospital, Beijing Shijitan Hospital, Beijing Tiantan Hospital, Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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