Gastric Cancer Surgery in Elderly Patients (GCSEP)

• ClinicalTrials.gov Identifier: NCT03777540
• Recruitment Status: Completed
• First Posted: December 17, 2018
• Last Update Posted: December 17, 2018
• Sponsor: University of Bologna
• Information provided by (Responsible Party): Marialuisa Lugaresi, University of Bologna

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Gastric Cancer	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 Design

• Study Type: Observational
• Actual Enrollment: 236 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Post-Operative Outcomes And Predictors Of Mortality After Gastric Cancer Surgery In The Very Elderly Patients
• Actual Study Start Date: January 1, 2010
• Actual Primary Completion Date: December 31, 2015
• Actual Study Completion Date: June 30, 2018

Groups and Cohorts

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).

Outcome Measures

Primary Outcome Measures :

1. Post-operative mortality In-hospital mortality was defined that occurred during hospitalization up to 90 days excluded post-operative mortality. Postoperative mortality [ Time Frame: Up to 90-days ]
   mortality occurred up to 90 days from surgery

Secondary Outcome Measures :

1. Overall survival [ Time Frame: Up to 5-years ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 80 Years to 90 Years (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

University of Bologna

Investigators

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

More Information

• Responsible Party: Marialuisa Lugaresi, Adjunct Professor, University of Bologna
• ClinicalTrials.gov Identifier: NCT03777540
• Other Study ID Numbers: Gastric Cancer Surgery
• First Posted: December 17, 2018
• Last Update Posted: December 17, 2018
• Last Verified: December 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases