Gastric Cancer Surgery in Elderly Patients

Gastric Cancer Clinical Trial

— GCSEP  

Official title:

Post-Operative Outcomes And Predictors Of Mortality After Gastric Cancer Surgery In The Very Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03777540
• Other study ID #: Gastric Cancer Surgery
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: June 30, 2018

Study information

• Verified date: December 2018
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Gastric cancer is most frequent after the fifth decade of life. Surgical risk is higher in aged population because of general health condition may affect the postoperative result. Aim of the study was to identify risk factors for post-operative mortality in octogenarian patients who underwent surgery for gastric cancer.

Description:

236 patients (181: 80-85 years old and 55: >85 years old) underwent surgery for gastric cancer at the Sant'Orsola-Malpighi University Hospital in Bologna between 2010 and 2015. The variables of the two groups of patients were compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: June 30, 2018
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with histologically confirmed primary gastric cancer submitted to surgical treatment;

• Age > 80 years.

Exclusion Criteria:

• Patients with histologically confirmed primary gastric cancer submitted to surgical treatment and age < 80 years;

• Patients with histologically diagnosis of other neoplastic and non-neoplastic diseases submitted to surgical treatment.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Gastric resection
Partial gastrectomy with jejunal anastomosis," "total gastrectomy," "gastroenterostomy without gastrectomy" or "other" (palliative surgery).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative mortality In-hospital mortality was defined that occurred during hospitalization up to 90 days excluded post-operative mortality. Postoperative mortality	mortality occurred up to 90 days from surgery	Up to 90-days
Secondary	Overall survival	Overall survival was defined as the time from the date of surgery to patient death (including surgery-associated death or hospital death), or the date of last available information concerning vital status.	Up to 5-years