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NCT Number: NCT03629808

Laparoscopic Sleeve Gastrectomy: a Cohort Study

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.

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Key information

Conditions

Laparoscopic Sleeve Gastrectomy

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. The incidence rate of upper gastrointestinal symptoms after surgery

    Time frame: 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 outcomes

  1. The excess weight loss (%EWL) after surgery

    Time frame: 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)

  2. the rate of postoperative complications after surgery

    Time frame: 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)

  3. The extent of upper gastrointestinal symptoms after surgery

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Collaborators

  • Beijing Hospital
  • Beijing Shijitan Hospital, Capital Medical University
  • Beijing Tiantan Hospital
  • Peking Union Medical College Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 14, 2018
Registry last updated
Apr 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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