Gastrectomy Outcomes in Elderly Patients (GOE)

October 14, 2021 updated by: Tevfik Kivilcim Uprak, Marmara University
In this study, the investigators aimed to identify independent prognostic factors for early postoperative complications and survival in elderly patients (aged ≥65 years) with gastric cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey, 34899
        • Marmara University Pendik Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 100 years (Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population of the research consists of patients who underwent gastrectomy with the diagnosis of gastric cancer in the General Surgery Clinic of Marmara University Pendik Training and Research Hospital, aged 65 and older between January 2014 and December 2020.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complication rate
Time Frame: Within 30 days after surgery
Complications will be reported and graded according to the Clavien-Dindo classification of surgical complications.
Within 30 days after surgery
Postoperative mortality
Time Frame: Within 30 days after surgery
Mortality during 30 days after surgery.
Within 30 days after surgery
Overall survival
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Principal Investigator: Tevfik Uprak, MD, Marmara University Pendik Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

September 28, 2021

First Posted (Actual)

October 8, 2021

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21s01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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