- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05071755
Gastrectomy Outcomes in Elderly Patients (GOE)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Gastric cancer is the 5th most common type of cancer diagnosed worldwide and ranks 3rd in cancer-related deaths. Along with surgical resection, perioperative chemotherapy or chemoradiotherapy are the main treatment method. Various complications can be seen in the postoperative period, mainly pulmonary complications (13%), cardiac complications (6%), intra-abdominal abscesses (4%), and anastomotic leaks (3%). Approximately 5% of the patients die because of postoperative complications. It is known that low body mass index as a patient-specific factor is associated with postoperative complications and poor prognosis.
The incidence of gastric cancer remains relatively high and, with increasing life expectancy, the incidence of gastric cancer in elderly patients is increasing. Characteristics of elderly patients, such as reduced physiological function, poor nutritional status, and surgical trauma from radical gastrectomy, seem to result in higher postoperative morbidity, a longer length of hospital stays, increased healthcare costs, and higher postoperative mortality. Elderly patients may have a worse prognosis compared to younger patients, primarily because of the increased risk of postoperative complications. Perioperative nutritional support and preoperative rehabilitation are beneficial for elderly patients with gastric cancer and may reduce surgical complications and mortality. Although some studies in the literature state that radical surgery can be performed for those aged 80 and over, some studies have argued that complications increase in elderly patients and that surgery should be limited.
Aim of the study is to identify prognostic factors for postoperative outcomes in elderly patients who underwent surgery for gastric cancer.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Tevfik Uprak, MD
- Telefonnummer: 905337273328
- E-post: kuprak@gmail.com
Studieorter
-
-
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Istanbul, Kalkon, 34899
- Marmara University Pendik Training and Research Hospital
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Kontakt:
- Tevfik Uprak, MD
- Telefonnummer: 905337273328
- E-post: kuprak@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients aged 65 and older
- Operable patients with histologically confirmed gastric cancer
- Complete follow-up information
Exclusion Criteria:
- Patients under 65 years of age
- Gastric resection for non-neoplastic diseases
- Missing follow-up information
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Postoperative complication rate
Tidsram: Within 30 days after surgery
|
Complications will be reported and graded according to the Clavien-Dindo classification of surgical complications.
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Within 30 days after surgery
|
Postoperative mortality
Tidsram: Within 30 days after surgery
|
Mortality during 30 days after surgery.
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Within 30 days after surgery
|
Overall survival
Tidsram: Five years
|
Overall survival is defined as the time interval from the time of the radical gastrectomy to the date of all-cause death or the last follow-up.
|
Five years
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Tevfik Uprak, MD, Marmara University Pendik Training and Research Hospital
Publikationer och användbara länkar
Allmänna publikationer
- Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
- Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.
- Araki I, Hosoda K, Yamashita K, Katada N, Sakuramoto S, Moriya H, Mieno H, Ema A, Kikuchi S, Mikami T, Watanabe M. Prognostic impact of venous invasion in stage IB node-negative gastric cancer. Gastric Cancer. 2015 Apr;18(2):297-305. doi: 10.1007/s10120-014-0362-2. Epub 2014 Apr 1.
- Etoh T, Katai H, Fukagawa T, Sano T, Oda I, Gotoda T, Yoshimura K, Sasako M. Treatment of early gastric cancer in the elderly patient: results of EMR and gastrectomy at a national referral center in Japan. Gastrointest Endosc. 2005 Dec;62(6):868-71. doi: 10.1016/j.gie.2005.09.012.
- Onodera T, Goseki N, Kosaki G. [Prognostic nutritional index in gastrointestinal surgery of malnourished cancer patients]. Nihon Geka Gakkai Zasshi. 1984 Sep;85(9):1001-5. Japanese.
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 21s01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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