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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03624725
• Other study ID #: 2018-02-R
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2022
• Source: The Third Affiliated Hospital of Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 592
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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%

Related Conditions & MeSH terms

• Quality of Life
• Stomach Neoplasms

Intervention

Procedure:
• modified BII+Braun
modified BII+Braun digestive tract reconstruction

Locations

Country	Name	City	State
China	Gastrointestinal surgery of the affiated tumor hospital	Harbin	Helongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Xue Yingwei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.