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NCT Number: NCT06938139

Defining Benchmarks for Gastric Cancer Patients Underwent Minimal Invasive Gastrectomy

The Benchmark-MISGC study was a large-scale retrospective observational study launched by the China Gastric Cancer Surgical Union, aiming to establish the benchmarks of the short- and long-term outcomes for gastric cancer patients who underwent minimal invasive gastrectomy.

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This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian medical university union hospital

Fuzhou, Fujian, 350000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with postoperative histologically confirmed gastric adenocarcinoma at stages T1-4a, N0/+, M0;
  • underwent robotic or laparoscopic gastrectomies with curative intent

Exclusion criteria

  • ASA class > 3;
  • remnant gastric cancer;
  • concurrent/previous malignant disease;
  • Distant metastasis;
  • Palliative resection;
  • Abodominal exploration.

Treatment and study plan

None-placebo

Other

None, observational study

Primary outcomes

  1. Benchmark values of overall complication

    Time frame: 30 days

    Median values of continuous variables and the proportions of categorical variables were calculated per participating centre. Benchmark values, indicating 'best achievable' results for each outcome indicator, were set at the 25th percentile for positive parameters (for example lymph node yield) or the 75th percentile for negative parameters (for example complications) of the centers' median values. Postoperative complications were evaluated within 30 days following surgery. These postoperative complications include gastrointestinal-related complications, incision-related complications, respiratory complications, cardiovascular and cerebrovascular complications, urinary system complications, infection complications, embolism complications, and other complications. The grading of postoperative complications adopts the Clavien-Dindo classification.

Secondary outcomes

  1. Benchmark values of Overall survival (OS)

    Time frame: 1-year, 2-year and 3-year

    Benchmark values of 1-year, 2-year and 3-year OS. OS was defined as the time from surgery to death from any cause or last follow-up.

  2. Benchmark values of Disease-specific survival (DSS)

    Time frame: 1-year, 2-year, and 3-year

    Benchmark values of 1-year, 2-year and 3-year DSS. DSS was defined as the time from surgery to death from gastric cancer, or last follow-up.

  3. benchmark value of the number of harvest lymph nodes

    Time frame: 1 month

    the number of harvest lymph nodes

  4. Benchmark values of Mortality rates

    Time frame: 30 days

    Patient died during hospitalization.

  5. Benchmark values of the incidence of intraoperative complications

    Time frame: 1 days

    Intraoperative complications were defined as bleeding due to named vessel injury, injury to visceral organs, mechanical factor-related problems, cardiopulmonary dysfunction due to hypercapnia, and other complications

  6. Benchmark values of Intraoperative blood loss

    Time frame: 1 day

    Intraoperative blood loss

  7. Benchmark values of operation time

    Time frame: 1 day

    From skin incision to skin closure

  8. Benchmark values of textbook Outcome

    Time frame: 30 days

    Textbook outcome (TO) was defined based on review of existing TO metrics in the literature including outcomes such as complete-potentially curative status, no intraoperative complications, no eventful postoperative complications (Clavien-Dindo grade III or higher), 15 lymph nodes(LNs) examined, hospital stay < 21days, no reintervention (surgical, endoscopic or radiological) within 30 days after surgery, no readmission to the intensive care unit (ICU) within 30 days after surgery, no postoperative mortality within 30 days after surgery, and no hospital readmission within 30 days after discharge. When all nine desired health outcomes were realized, TO was achieved.

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study title

Defining Benchmarks for Gastric Cancer Patients Underwent Minimal Invasive Gastrectomy: A Multicentre Analysis

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2025
Registry last updated
Apr 22, 2025

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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