Early Detection of Postoperative Anastomotic Leak by CT | NCT03632395

Studies
Early Detection of Postoperative Anastomotic Leak by CT

NCT03632395

Sponsor

BIRENDRA KUMAR SAH

Status

Completed

Last Update Posted

May 21, 2020Actual

Enrollment

110Actual

Phase

Not provided

Conditions

Anastomotic Leak

Interventions

computed tomography

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2015Actual

Primary Completion Date

Jun 1, 2018Actual

Completion Date

Jun 1, 2018Actual

First Submitted Date

Aug 13, 2018

First Submission Date that Met QC Criteria

Aug 13, 2018

First Posted Date

Aug 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2020

Last Update Posted Date

May 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

Postoperative anastomotic leak is rare but life threatening complication after gastric cancer surgery. Early diagnosis is key to minimize other hazards which are caused by anastomotic leak. Investigators introduced a novel method to detect early diagnosis of anastomotic leak after gastric cancer surgery. Oral contrast agent is used for CT. Investigators carefully collected all the data prospectively and standard definition of anastomotic leak was applied.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Name	Type	Description	Arm Group Labels	Other Names
computed tomography	Diagnostic Test	computed tomography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis of anastomotic leak	CT was routinely used to detect early anastomotic leak after gastric cancer surgery	5-10 days after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with gastric cancer surgery

Exclusion Criteria:

Patients with non gastric cancer surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent gastric cancer surgery.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
BIRENDRA K SAH, Ph D	Ruijin Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruijin Hospital Shanghai Jiaotong University School of Medicine		Shanghai	Shanghai Municipality	200025	China

Condition Browse Module

MeSH Terms

ID	Term
D057868	Anastomotic Leak
D013274	Stomach Neoplasms
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014057	Tomography, X-Ray Computed

Ancestor Terms

ID	Term
D007090	Image Interpretation, Computer-Assisted
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided