Clinical trial NCT05280665: Specialization in Gastric Cancer Surgery
Official title: The Impact of Specialization on Clinical Outcomes in Gastric Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stomach Neoplasms
Gastric Cancer
Keywords: Specialization
Postoperative Complications
Morbidity
Gastrectomy
Gastric Cancer
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 537
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with clinical stage 1-3 gastric adenocarcinoma undergoing surgical treatment for curative purposes

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days after the operation (postoperative hospital stay ≤ 30 days) or operation to first discharge from hospital (postoperative hospital stay > 30 days)
Secondary outcomes:
measure: 90-day mortality
timeFrame: 90 days after the operation (postoperative hospital stay ≤ 90 days) or operation to first discharge from hospital (postoperative hospital stay > 90 days)
measure: Postoperative complication rate
timeFrame: Within 30 days after the operation
measure: Postoperative major complication rate
timeFrame: Within 30 days after the operation
measure: Readmission
timeFrame: Within 30 days after the operation
measure: 3-year overall survival
timeFrame: 3 years after surgery
measure: 3-year recurrence-free survival
timeFrame: 3 years after surgery
measure: Hospital stay
timeFrame: From the date of surgery until the date of hospital discharge, assessed up to 90 days after the operation
Other outcomes:
measure: Failure-to-cure
timeFrame: Within 30 days after the operation
measure: Neoadjuvant treatment usage
timeFrame: Within the three months before surgery
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University, Faculty of Medicine, Farabi Hospital
Study officials:
affiliation: Karadeniz Technical University Faculty of Medicine
name: Ali Guner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liang Y, Wu L, Wang X, Ding X, Liang H. The positive impact of surgeon specialization on survival for gastric cancer patients after surgery with curative intent. Gastric Cancer. 2015 Oct;18(4):859-67. doi: 10.1007/s10120-014-0436-1. Epub 2014 Oct 15.
citation: Bachmann MO, Alderson D, Edwards D, Wotton S, Bedford C, Peters TJ, Harvey IM. Cohort study in South and West England of the influence of specialization on the management and outcome of patients with oesophageal and gastric cancers. Br J Surg. 2002 Jul;89(7):914-22. doi: 10.1046/j.1365-2168.2002.02135.x.
citation: Claassen YHM, van Amelsfoort RM, Hartgrink HH, Dikken JL, de Steur WO, van Sandick JW, van Grieken NCT, Cats A, Boot H, Trip AK, Jansen EPM, Kranenbarg EM, Braak JPBM, Putter H, van Berge Henegouwen MI, Verheij M, van de Velde CJH. Effect of Hospital Volume With Respect to Performing Gastric Cancer Resection on Recurrence and Survival: Results From the CRITICS Trial. Ann Surg. 2019 Dec;270(6):1096-1102. doi: 10.1097/SLA.0000000000002940.
citation: Callahan MA, Christos PJ, Gold HT, Mushlin AI, Daly JM. Influence of surgical subspecialty training on in-hospital mortality for gastrectomy and colectomy patients. Ann Surg. 2003 Oct;238(4):629-36; discussion 636-9. doi: 10.1097/01.sla.0000089855.96280.4a.