Gastric Cancer Surgery in Elderly Patients (GCSEP)

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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: Gastric resection

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 236

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Age; timing of gastric resection; Patients 80-85 years; Patients > 85 years; Elective and urgent surgery.	Procedure: Gastric resection; Partial gastrectomy with jejunal anastomosis," "total gastrectomy," "gastroenterostomy without gastrectomy" or "other" (palliative surgery).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Bologna
• Investigators: Study Chair: Bruno Nardo, MD,PhD, University of Bologna

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: December 7, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): December 17, 2018
• Last Update Submitted That Met QC Criteria: December 14, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: Gastric Cancer Surgery

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No