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

Primary Purpose

Quality of Life

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
modified BII+Braun
Sponsored by
Xue Yingwei
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life focused on measuring Gastric cancer, Quality of life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Gastrointestinal surgery of the affiated tumor hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

modified BII+Braun

traditional BII+Braun

Arm Description

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

traditional BII+Braun digestive tract reconstruct

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 29, 2018
Last Updated
October 4, 2022
Sponsor
Xue Yingwei
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1. Study Identification

Unique Protocol Identification Number
NCT03624725
Brief Title
A Clinical Study of the Effects of Modified BII+Braun on Quality of Life After for Distal Gastric Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xue Yingwei

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life
Keywords
Gastric cancer, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
592 (Actual)

8. Arms, Groups, and Interventions

Arm Title
modified BII+Braun
Arm Type
Active Comparator
Arm Description
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
Arm Title
traditional BII+Braun
Arm Type
No Intervention
Arm Description
traditional BII+Braun digestive tract reconstruct
Intervention Type
Procedure
Intervention Name(s)
modified BII+Braun
Intervention Description
modified BII+Braun digestive tract reconstruction
Primary Outcome Measure Information:
Title
Effects of quality of life
Description
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
Time Frame
The quality of life questionnaire was conducted at six months after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingwei Xue, doctor
Organizational Affiliation
Director of Gastrointestinal surgery
Official's Role
Study Director
Facility Information:
Facility Name
Gastrointestinal surgery of the affiated tumor hospital
City
Harbin
State/Province
Helongjiang
ZIP/Postal Code
150001
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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