NCT03958032

Brief Summary

We aimed to establish the effects of sarcopenia on postoperative complications among patients undergoing surgical treatment for gastric cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
185

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

December 3, 2016

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

3.4 years

First QC Date

May 18, 2019

Last Update Submit

June 13, 2020

Conditions

Gastric CancerSarcopeniaMalnutrition; CachexiaComplication

Keywords

sarcopeniacancergastrointestinal

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    complications graded by Clavien-Dindo Complication Classification System

    within 30 days after surgery

Secondary Outcomes (9)

  • Length of hospital stay

    up to 90 days

  • Mortality

    within 30 days after surgery

  • Readmission rate

    within 30 days after surgery

  • Incidence of sarcopenia

    one day before surgery

  • Muscle mass volume

    one day before surgery

  • +4 more secondary outcomes

Study Arms (1)

Participants with gastric cancer

All consecutive patients undergoing surgery due to gastric cancer will be included in this study.

Other: No intervention

Interventions

No interventionOTHER

No intervention is planned for the participants for the treatment of gastric cancer. Treatment decision will be in line with clinical practice guidelines. Surgical team will be blind to the participant's sarcopenia status.

Participants with gastric cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients undergoing surgery due to gastric cancer will be included in this study.

You may qualify if:

  • Patients undergoing gastric surgery for gastric cancer
  • Histologically proven gastric adenocarcinoma
  • Patients over 18 years
  • Patients who agreed to participate in the study

You may not qualify if:

  • patients treated by non-surgical treatment such as endoscopic treatment, palliative chemotherapy)
  • patients received palliative surgery without gastric resection (bypass procedures)
  • patients required thoracotomy/thoracoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University, Faculty of Medicine

Trabzon, 61080, Turkey (Türkiye)

Location

Related Publications (4)

  • Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

    PMID: 20392703BACKGROUND

  • Fukuda Y, Yamamoto K, Hirao M, Nishikawa K, Nagatsuma Y, Nakayama T, Tanikawa S, Maeda S, Uemura M, Miyake M, Hama N, Miyamoto A, Ikeda M, Nakamori S, Sekimoto M, Fujitani K, Tsujinaka T. Sarcopenia is associated with severe postoperative complications in elderly gastric cancer patients undergoing gastrectomy. Gastric Cancer. 2016 Jul;19(3):986-93. doi: 10.1007/s10120-015-0546-4. Epub 2015 Sep 25.

    PMID: 26407875BACKGROUND

  • Tegels JJ, van Vugt JL, Reisinger KW, Hulsewe KW, Hoofwijk AG, Derikx JP, Stoot JH. Sarcopenia is highly prevalent in patients undergoing surgery for gastric cancer but not associated with worse outcomes. J Surg Oncol. 2015 Sep;112(4):403-7. doi: 10.1002/jso.24015. Epub 2015 Aug 31.

    PMID: 26331988BACKGROUND

  • Guner A. Recent trends of gastric cancer treatment in Turkey. Transl Gastroenterol Hepatol. 2017 Apr 26;2:31. doi: 10.21037/tgh.2017.04.01. eCollection 2017.

    PMID: 28529985BACKGROUND

MeSH Terms

Conditions

Stomach NeoplasmsSarcopeniaMalnutritionCachexiaNeoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsNutrition DisordersNutritional and Metabolic DiseasesWeight LossBody Weight ChangesBody WeightThinness

Study Officials

  • Ali GUNER, MD

    Karadeniz Technical University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 18, 2019

First Posted

May 21, 2019

Study Start

December 3, 2016

Primary Completion

May 10, 2020

Study Completion

June 10, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)