Laparoscopic Sleeve Gastrectomy: a Cohort Study

NCT ID: NCT03629808

Last Updated: 2020-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-10

Study Completion Date

2020-04-20

Brief Summary

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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.

Detailed Description

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Conditions

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Laparoscopic Sleeve Gastrectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group1: 4-6cm

4-6cm from starting point of gastrectomy to pylorus

4-6cm from starting point of gastrectomy to pylorus

Intervention Type PROCEDURE

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

Group2: 2-4cm

2-4cm from starting point of gastrectomy to pylorus

2-4cm from starting point of gastrectomy to pylorus

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

Beijing Shijitan Hospital, Capital Medical University

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhongtao Zhang

Director of general surgery, principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhongtao Zhang

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

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Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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

Reference Type RESULT

Other Identifiers

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BFH-LSG 01

Identifier Type: -

Identifier Source: org_study_id

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