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Completed

NCT Number: NCT05280665

Specialization in Gastric Cancer Surgery

Specialization is having competent and effective knowledge on a subject, and the tendency towards specialization is increasing due to the fact that it increases the success in the follow-up and treatment process of diseases. It has been observed that specialization in cancer surgery provides significant improvement in clinical outcomes in recent years. In this study, the effect of specialization in gastric cancer surgery on clinical outcomes is being investigated.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karadeniz Technical University, Faculty of Medicine, Farabi Hospital

Trabzon, 61080, Turkey (Türkiye)

About this study

Specialization is having sufficient and effective knowledge on a subject. Today, in the medical world, specialization is defined as having competent knowledge on a disease, and in recent years, the benefit of specialization has begun to be emphasized. Initially, it was defined as a branching and over the years, internal and surgical departments were divided into sub-areas. In surgical sciences, these fields are determined as traumatology, breast-endocrine surgery and gastrointestinal system surgery. This branching has brought a different perspective and approach to diseases and has made it possible to be more effective in the management of diseases. In recent years, a specialization approach on diseases and organ systems has developed within these branches. In surgery, surgeons specialized on many organs such as pancreatic surgery, colorectal surgery, gastric surgery, breast surgery, ovarian surgery have increased the efficiency in the management of diseases and the survival and disease-free survival rates of the patients have increased, and the postoperative morbidity and mortality rates have decreased.

Gastric cancer is one of the most common malignant cancers. It is the fifth most common cause of cancer-related death worldwide. Despite advances in diagnosis and treatment methods, patients may still be diagnosed late, and patients still have a poor prognosis due to the biology of gastric cancer. Even in properly treated patients, five-year survival rates are around 20-30%. With the development of surgical techniques and disease management, clinical outcomes of the disease have improved and mortality has been reduced. In the studies, the definition of gastric surgeon was created and it was determined that the mortality decreased proportionally with the increase in the patient volume of the surgeon. In gastric cancer surgery, there are mostly studies on the number of surgeon patients and the number of hospital patients. Post-hoc analysis of hospital volume on patients included in the CRITICS study showed a 13.1% increase in survival in high-volume hospitals compared to low-volume hospitals. The number of annual resections ≥21 was determined as the definition of high-volume hospital. In addition, it was determined that there was a decrease in mortality as the number of annual cases increased in high-volume hospitals. In another study, it was seen that there was an improvement in the mortality of medium and high volume hospitals compared to low volume hospitals. The majority of studies in gastric cancer surgery have focused on hospital volume and surgeon volume. There are no data on the specialization of the surgeon other than a study based in Japan.

In this study, it was aimed to evaluate the effect of specialization in gastric cancer surgery on short- and long-term clinical outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • cStage I/II/III gastric cancer
  • Histologically proven gastric adenocarcinoma
  • Underwent surgery with curative intent

Exclusion criteria

  • Under 18 years old
  • Patients with non-adenocarcinoma diagnosis
  • Emergency surgeries
  • The need for a thoracic approach
  • Patients with a history of non-gastric cancer

Treatment and study plan

Specialization

Other
  • Who had undergone professional training in gastric cancer surgery in specialized gastric cancer centers (in Japan or Korea),
  • Who identified themselves as primarily gastric surgeons during the study period
  • Whose annual gastric cancer surgery volume is more than 21

Other names: Gastric cancer surgery

Primary outcomes

  1. 30-day mortality

    Time frame: 30 days after the operation (postoperative hospital stay ≤ 30 days) or operation to first discharge from hospital (postoperative hospital stay > 30 days)

    Death from any cause within 30 days after surgery or at any time if not discharged from hospital

Secondary outcomes

  1. 90-day mortality

    Time frame: 90 days after the operation (postoperative hospital stay ≤ 90 days) or operation to first discharge from hospital (postoperative hospital stay > 90 days)

    Death from any cause within 90 days after surgery or at any time if not discharged from hospital

  2. Postoperative complication rate

    Time frame: Within 30 days after the operation

    Any complications (graded by the Clavien-Dindo classification) occurred in the postoperative period

  3. Postoperative major complication rate

    Time frame: Within 30 days after the operation

    ≥grade-III Clavien-Dindo complications occurred in the postoperative period

  4. Readmission

    Time frame: Within 30 days after the operation

    Readmission requiring re-hospitalization for any complications after discharge

  5. 3-year overall survival

    Time frame: 3 years after surgery

    Death from any cause is defined as an event.

  6. 3-year recurrence-free survival

    Time frame: 3 years after surgery

    Death from any cause or the recurrence of gastric cancer are an event.

  7. Hospital stay

    Time frame: From the date of surgery until the date of hospital discharge, assessed up to 90 days after the operation

    Duration of postoperative hospital stays

Other outcomes

  1. Failure-to-cure

    Time frame: Within 30 days after the operation

    futile surgery due to intraoperative distant metastasis/irresectability, OR microscopically or macroscopically incomplete resection OR 30-day mortality

  2. Neoadjuvant treatment usage

    Time frame: Within the three months before surgery

    Neoadjuvant treatment usage rates in patients undergoing surgical treatment

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

The Impact of Specialization on Clinical Outcomes in Gastric Cancer Surgery

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 15, 2022
Registry last updated
Mar 21, 2023

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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