A Clinical Study of the Effects of Modified BII+Braun on Quality of Life After for Distal Gastric Cancer

Study Overview
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Brief Summary
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The jejunum of the input segment is properly ligated with double line 7 at 3-5cm from the anastomotic site, and the jejunum of the output segment is extended to 30cm

Detailed Description
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The T1-4a N0-3 M0 gastric adenocarcinoma patients were used to evaluate whether the quality of life after modified BII+Braun digestive tract reconstruction was superior to the traditional BII+Braun digestive tract reconstruction

Official Title
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A Single-center, Randomized, Controlled Clinical Study of the Effects of Modified and Traditional BII+Braun Digestive Tract Reconstruction Methods on Quality of Life After Radical Gastrectomy for Distal Gastric Cancer

Conditions
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Quality of Life

Intervention / Treatment
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* Procedure: modified BII+Braun


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18<age<75 Gastric lesions were diagnosed as gastric adenocarcinoma by endoscopic biopsy The preoperative clinical stage is T1-4a,N0-3,M0(According to AJCC- 7th TNM tumor stage) It is expected that the results of R0 surgery can be obtained by performing distal gastrectomy and D2 lymph node dissection Preoperative ECOG performance status score 0/1 Nutrition risk screening（NRS2002） Preoperative ASA score I-III Patient informed consent Exclusion Criteria: Pregnancy or breastfeeding women Severe mental illness History of upper abdominal surgery History of gastric surgery (including ESD/EMR for gastric cancer) 3 years of history of other malignant diseases； Gastric cancer patients who have undergone neoadjuvant treatment or recommend neoadjuvant treatment A history of unstable angina or myocardial infarction within 6 months History of cerebral infarction or cerebral hemorrhage within 6 months There is a history of sustained systemic corticosteroid treatment within 1 month Needs simultaneous surgical treatment of other diseases； Gastric cancer complications (bleeding, perforation, obstruction) require emergency surgery Pulmonary function test FEV<1 predicted value 50%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: modified BII+Braun<br>The jejunum of the input segment is properly ligated with double line 7 at 3-5cm from the anastomotic site, and the jejunum of the output segment is extended to 30cm | Procedure: modified BII+Braun<br>* modified BII+Braun digestive tract reconstruction<br>|
| No Intervention: traditional BII+Braun<br>traditional BII+Braun digestive tract reconstruct | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of quality of life | The GSRS scoring system was used to understand the functional status of the digestive tract and its impact on quality of life in postoperative patients .The GSRS scoring system was 0-3, with 0 being the mildest and 3 being the most severe | The quality of life questionnaire was conducted at six months after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, Quality of life