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GastrectomyGOENCT05071755

Gastrectomy Outcomes in Elderly Patients

An observational study of Gastrectomy and Elderly, run by Marmara University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 to 100 years
Conditions the study is for
Gastrectomy, Elderly, Gastric Cancer
What is being tested?
Gastrectomy
Type of treatment
Surgery or procedure
How many people
350 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2021to 1 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 100 years
  • All sexes
  • Older adult

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.

Who may be able to join

  • Patients aged 65 and older
  • Operable patients with histologically confirmed gastric cancer
  • Complete follow-up information

Who cannot join

  • Patients under 65 years of age
  • Gastric resection for non-neoplastic diseases
  • Missing follow-up information

Trial locations and contacts

1 site in 1 country.

Tevfik Uprak, MD contact

905337273328

kuprak@gmail.com

Turkey (Türkiye)1 site

  • Marmara University Pendik Training and Research Hospital

    Istanbul, 34899

    Tevfik Uprak, MD, 905337273328, kuprak@gmail.com

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Being tested
Gastrectomy
Keywords
Gastrectomy, Elderly, Gastric Cancer, Prognosis
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GastrectomyProcedure or surgery

    Radical Total Gastrectomy, Radical Partial gastrectomy (Proximal / Subtotal)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative complication rate

    Complications will be reported and graded according to the Clavien-Dindo classification of surgical complications.

    Measured: Within 30 days after surgery

  2. Postoperative mortality

    Mortality during 30 days after surgery.

    Measured: Within 30 days after surgery

  3. Overall survival

    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.

    Measured: Five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2021
  2. Study start1 Nov 2021 (estimated)
  3. Primary completion1 Feb 2022 (estimated)
  4. Study completion1 Mar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05071755
Sponsor's protocol ID
21s01
Acronym
GOE
Status last verified
Oct 2021
First submitted
28 Sep 2021
Last updated
19 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.

    PubMed 21351269

  • Araki I, Hosoda K, Yamashita K, Katada N, Sakuramoto S, Moriya H, Mieno H, Ema A, Kikuchi S, Mikami T, Watanabe M. Prognostic impact of venous invasion in stage IB node-negative gastric cancer. Gastric Cancer. 2015 Apr;18(2):297-305. doi: 10.1007/s10120-014-0362-2. Epub 2014 Apr 1.

    PubMed 24687437

  • Etoh T, Katai H, Fukagawa T, Sano T, Oda I, Gotoda T, Yoshimura K, Sasako M. Treatment of early gastric cancer in the elderly patient: results of EMR and gastrectomy at a national referral center in Japan. Gastrointest Endosc. 2005 Dec;62(6):868-71. doi: 10.1016/j.gie.2005.09.012.

    PubMed 16301028

  • Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

    PubMed 19638912

  • Onodera T, Goseki N, Kosaki G. [Prognostic nutritional index in gastrointestinal surgery of malnourished cancer patients]. Nihon Geka Gakkai Zasshi. 1984 Sep;85(9):1001-5. Japanese.

    PubMed 6438478

Questions about this trial

What is this clinical trial studying?

An observational study of Gastrectomy and Elderly, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tevfik Uprak, MD (905337273328, kuprak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative complication rate (time frame: Within 30 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05071755, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021; AzTrials last refreshed its copy on 3 Nov 2026.

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