Clinical trial NCT03629808: Laparoscopic Sleeve Gastrectomy: a Cohort Study
Official title: The Effect of Residual Gastric Antrum Size During Laparoscopic Sleeve Gastrectomy in Reducing Postoperative Gastrointestinal Symptoms: a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopic Sleeve Gastrectomy
Keywords: metabolic surgery
laparoscopic sleeve gastrectomy
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Beijing Tiantan Hospital
name: Beijing Hospital
name: Beijing Shijitan Hospital, Capital Medical University
First posted: 2018-08-14
Enrollment: 138
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The incidence rate of upper gastrointestinal symptoms after surgery
timeFrame: 1 year after surgery
Secondary outcomes:
measure: The excess weight loss (%EWL) after surgery
timeFrame: 1 year after surgery
measure: the rate of postoperative complications after surgery
timeFrame: 1 year after surgery
measure: The extent of upper gastrointestinal symptoms after surgery
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhongtao Zhang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chow, S.C.; Shao, J.; Wang, H. 2003. Sample Size Calculations in Clinical Research. Marcel Dekker. New York.