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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
| Beijing Tiantan Hospital | OTHER |
| Beijing Hospital | OTHER_GOV |
| Beijing Shijitan Hospital, Capital Medical University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1: 4-6cm | 4-6cm from starting point of gastrectomy to pylorus |
| |
| Group2: 2-4cm | 2-4cm from starting point of gastrectomy to pylorus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The excess weight loss (%EWL) 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) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will comprise male and non-pregnant female patients, aged 16-65years both inclusive, with morbid obesity.
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| Name | Affiliation | Role |
|---|---|---|
| Zhongtao Zhang | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Beijing | Beijing Municipality | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Chow, S.C.; Shao, J.; Wang, H. 2003. Sample Size Calculations in Clinical Research. Marcel Dekker. New York. |
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| OTHER |
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| 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. |
|
| 1 year after surgery |
| the rate of postoperative complications 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) | 1 year after surgery |
| The extent 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 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) | 1 year after surgery |