Specialization in Gastric Cancer Surgery

Sponsor
Karadeniz Technical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05280665
Collaborator
(none)
274
1
11.6
23.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Specialization

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
274 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Impact of Specialization on Clinical Outcomes in Gastric Cancer Surgery
Actual Study Start Date :
Feb 14, 2022
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
The non-specialized group

Patients who were operated by a non-specialized surgeon. Non-specialized surgeons were defined as general surgeon who does not have the characteristics of a specialized gastric cancer surgeon.

The specialized group

Patients who were operated by a specialized gastric cancer surgeon. Specialized gastric cancer surgeons were defined as surgeons who meet all of the criteria for a specialized gastric cancer surgeon. 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: Specialization
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
  • Outcome Measures

    Primary Outcome Measures

    1. 30-day mortality [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 Outcome Measures

    1. 90-day mortality [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 [Within 30 days after the operation]

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

    3. Postoperative major complication rate [Within 30 days after the operation]

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

    4. Readmission [Within 30 days after the operation]

      Readmission requiring re-hospitalization for any complications after discharge

    5. 3-year overall survival [3 years after surgery]

      Death from any cause is defined as an event.

    6. 3-year recurrence-free survival [3 years after surgery]

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

    7. Hospital stay [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 Outcome Measures

    1. Failure-to-cure [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 [Within the three months before surgery]

      Neoadjuvant treatment usage rates in patients undergoing surgical treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karadeniz Technical University, Faculty of Medicine, Farabi Hospital Trabzon Turkey 61080

    Sponsors and Collaborators

    • Karadeniz Technical University

    Investigators

    • Principal Investigator: Ali Guner, MD, Karadeniz Technical University Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ali GUNER, Professor, MD, Karadeniz Technical University
    ClinicalTrials.gov Identifier:
    NCT05280665
    Other Study ID Numbers:
    • GastCaSpec
    First Posted:
    Mar 15, 2022
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ali GUNER, Professor, MD, Karadeniz Technical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 15, 2022