NCT03777540

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 17, 2018

Completed
Last Updated

December 17, 2018

Status Verified

December 1, 2018

Enrollment Period

6 years

First QC Date

December 7, 2018

Last Update Submit

December 14, 2018

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Overall survival

    Up to 5-years

Study Arms (1)

Age; timing of gastric resection

Patients 80-85 years; Patients \> 85 years; Elective and urgent surgery.

Procedure: Gastric resection

Interventions

Gastric resectionPROCEDURE

Partial gastrectomy with jejunal anastomosis," "total gastrectomy," "gastroenterostomy without gastrectomy" or "other" (palliative surgery).

Age; timing of gastric resection

Eligibility Criteria

Age80 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients with histologically confirmed primary gastric cancer submitted to surgical treatment;
  • Age \> 80 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastrectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Bruno Nardo, MD,PhD

    University of Bologna

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

December 7, 2018

First Posted

December 17, 2018

Study Start

January 1, 2010

Primary Completion

December 31, 2015

Study Completion

June 30, 2018

Last Updated

December 17, 2018

Record last verified: 2018-12