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Laparoscopic Sleeve Gastrectomy: a Cohort Study

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Capital Medical University

Status

Completed

Conditions

Laparoscopic Sleeve Gastrectomy

Treatments

Procedure: 2-4cm from starting point of gastrectomy to pylorus
Procedure: 4-6cm from starting point of gastrectomy to pylorus

Study type

Observational

Funder types

Other

Identifiers

NCT03629808
BFH-LSG 01

Details and patient eligibility

About

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.

Enrollment

138 patients

Sex

All

Ages

15 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

138 participants in 2 patient groups

Group1: 4-6cm
Description:
4-6cm from starting point of gastrectomy to pylorus
Treatment:
Procedure: 4-6cm from starting point of gastrectomy to pylorus
Group2: 2-4cm
Description:
2-4cm from starting point of gastrectomy to pylorus
Treatment:
Procedure: 2-4cm from starting point of gastrectomy to pylorus

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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