NCT03639792

Brief Summary

An objective analysis of postoperative complications is vital to escort octogenarian for gastric cancer surgery. Investigator carefully collected clinical data prospectively to pave way for standard management in high risk patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

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

January 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
Last Updated

May 22, 2020

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

August 17, 2018

Last Update Submit

May 21, 2020

Conditions

Gastric Cancer

Keywords

gastric cancerpostoperative complicationoctogenarian

Outcome Measures

Primary Outcomes (1)

  • Postoperative Morbidity and mortality

    Postoperative Morbidity and mortality according to standard definition

    One month after hospital discharge

Secondary Outcomes (1)

  • Overall survival

    upto two years

Interventions

gastric cancer surgeryPROCEDURE

Gastric cancer surgery

Eligibility Criteria

Age80 Years - 90 Years
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

A cohort of gastric cancer patients who underwent surgery during two consecutive years in a Chinese hospital.

You may qualify if:

  • \- Pathologically confirmed gastric cancer patients Clinically fit for gastric cancer surgery

You may not qualify if:

  • \- Non gastric cancer patients Clinically unfit for gastric cancer surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Stomach NeoplasmsPostoperative Complications

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Birendra K Sah, Ph D

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 17, 2018

First Posted

August 21, 2018

Study Start

January 1, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

May 22, 2020

Record last verified: 2018-08

Locations

CN(1)