Laparoscopic Sleeve Gastrectomy: a Cohort Study

NCT03629808 | Completed

• 1 other identifier: BFH-LSG 01
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Sleeve Gastrectomy

Keywords

metabolic surgery; laparoscopic sleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The excess weight loss (%EWL) after surgery

  1 year after surgery

• the rate of postoperative complications after surgery

  1 year after surgery

• The extent of upper gastrointestinal symptoms after surgery

  1 year after surgery

Study Arms (2)

Group1: 4-6cm

4-6cm from starting point of gastrectomy to pylorus

Procedure: 4-6cm from starting point of gastrectomy to pylorus

Group2: 2-4cm

2-4cm from starting point of gastrectomy to pylorus

Procedure: 2-4cm from starting point of gastrectomy to pylorus

Interventions

4-6cm from starting point of gastrectomy to pylorus PROCEDURE

The starting point of gastrectomy of the distance from the pylorus is 4-6cm during operative.

Group1: 4-6cm

2-4cm from starting point of gastrectomy to pylorus PROCEDURE

The starting point of gastrectomy of the distance from the pylorus is 2-4cm during operative.

Group2: 2-4cm

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead
• Peking Union Medical College Hospital: collaborator
• Beijing Tiantan Hospital: collaborator
• Beijing Hospital: collaborator
• Beijing Shijitan Hospital, Capital Medical University: collaborator

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (1)

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

  RESULT

Study Officials

• Zhongtao Zhang

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of general surgery, principal investigator

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 14, 2018
• Study Start: July 10, 2018
• Primary Completion: March 28, 2020
• Study Completion: April 20, 2020
• Last Updated: April 22, 2020

Record last verified: 2020-04

Locations

CN (1)