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NCT Number: NCT03624725

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

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

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Key information

Conditions

Quality of Life Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gastrointestinal surgery of the affiated tumor hospital

Harbin, Helongjiang, 150001, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

modified BII+Braun

Procedure

modified BII+Braun digestive tract reconstruction

Primary outcomes

  1. Effects of quality of life

    Time frame: The quality of life questionnaire was conducted at six months after surgery.

    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

Sponsors and collaborators

Lead sponsor

Xue Yingwei

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2018
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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