Skip to main content
OpenTrials
Completed

NCT Number: NCT03958032

Effects of Sarcopenia on Early Postoperative Outcomes in Patients Undergoing Surgical Treatment for Gastric Cancer

We aimed to establish the effects of sarcopenia on postoperative complications among patients undergoing surgical treatment for gastric cancer

Completed

Looking for future studies?

Notify Me

Key information

About this study

Among gastrointestinal disease, gastric cancer is a malignancy which is diagnosed predominantly in advanced stages, mostly accompanied with malnutrition when diagnosed, has aggressive behavior with poor oncological outcomes. The only option for curative treatment is surgical resection in this malignancy; however, the surgical procedure itself causes high morbidity and mortality rates. Therefore, physicians combine various treatment modalities and risk assessment to decrease complication and mortality rates.

Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life, and death. For the diagnosis of sarcopenia, using the presence of both low muscle mass and decreased muscle function (strength or performance) is recommended. Previous studies showed that colorectal or pancreatic cancer accompanied with sarcopenia has adverse effects on not only for short term and also for long term outcomes. The majority of studies regarding gastric cancer was published from Eastern countries owing to their high incidence. There are few studies from western countries which are mostly retrospective and does not meet the diagnostic criteria of sarcopenia. In the western population, there is no high-quality evidence so far regarding the impact of sarcopenia on early outcomes of gastric cancer surgical treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing gastric surgery for gastric cancer
  • Histologically proven gastric adenocarcinoma
  • Patients over 18 years
  • Patients who agreed to participate in the study

Exclusion criteria

  • patients treated by non-surgical treatment such as endoscopic treatment, palliative chemotherapy)
  • patients received palliative surgery without gastric resection (bypass procedures)
  • patients required thoracotomy/thoracoscopy

Treatment and study plan

No intervention

Other

No intervention is planned for the participants for the treatment of gastric cancer. Treatment decision will be in line with clinical practice guidelines. Surgical team will be blind to the participant's sarcopenia status.

Primary outcomes

  1. Postoperative complications

    Time frame: within 30 days after surgery

    complications graded by Clavien-Dindo Complication Classification System

Secondary outcomes

  1. Length of hospital stay

    Time frame: up to 90 days

    time interval from the date of operation to the date of discharge

  2. Mortality

    Time frame: within 30 days after surgery

    Dying after surgery

  3. Readmission rate

    Time frame: within 30 days after surgery

    readmission to the hospital because of the adverse events after discharge

  4. Incidence of sarcopenia

    Time frame: one day before surgery

    Sarcopenia consensus defined by The European Working Group on Sarcopenia in Older People

  5. Muscle mass volume

    Time frame: one day before surgery

    muscle mass volume of a cross-sectional computerized- tomography image of the L3, corrected for patient height resulting in L3 muscle index.

  6. Psoas muscle mass volume

    Time frame: one day before surgery

    muscle mass volume of Psoas muscle with 3D reconstruction

  7. Muscle strength

    Time frame: one day before surgery

    evaluated by handgrip strength test (with digital dynamometer)

  8. Physical performance

    Time frame: one day before surgery

    evaluated by 4-meter gait speed test

  9. Major complication

    Time frame: within 30 days after surgery

    grade 3 or higher complications graded by Clavien-Dindo Complication Classification System

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 21, 2019
Registry last updated
Jun 16, 2020

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.

Published trials that share one or more normalized conditions with this study.