A Retrospective Cohort Study for Main Postoperative Compl... | NCT05781581

Studies
A Retrospective Cohort Study for Main Postoperative Complications After SARS-CoV-2 Infection

NCT05781581

Sponsor

RenJi Hospital

Status

Unknown status

Last Update Posted

Mar 23, 2023Actual

Enrollment

50,000Estimated

Phase

Not provided

Conditions

Intestines Cancer
Pulmonary Cancer
Liver Cancer
Trauma
Fractures, Bone
Gynecologic Disease

Interventions

no intervention

Countries

Not provided

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 19, 2023Estimated

Primary Completion Date

Aug 31, 2023Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Mar 12, 2023

First Submission Date that Met QC Criteria

Mar 12, 2023

First Posted Date

Mar 23, 2023Actual

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

Mar 12, 2023

Last Update Posted Date

Mar 23, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

RenJi HospitalOTHER

Collaborators

Name	Class
The First Affiliated Hospital of Anhui Medical University	OTHER
First Affiliated Hospital of Chongqing Medical University	OTHER
Sichuan Academy of Medical Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

To explore the relationship between SARS-CoV-2 infection in different time before operation and postoperative main complications (mortality, main pulmonary and cardiovascular complications) 30 days after operation; To determine the best timing of surgery after SARS-CoV-2 infection.

Detailed Description

Not provided

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

50,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality at 30 days after operation	All-cause mortality at 30 days after operation	30 days after surgery

Secondary Outcomes

Measure	Description	Time Frame
Main pulmonary complications at 30 days after operation	a composite of postoperative pneumonia, acute respiratory distress syndrome (ARDS) and unexpected ventilation	30 days after surgery
Major Adverse Cardiovascular Events (MACE)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age≥18 years;
Patients undergoing any type of surgery in operating room.

Exclusion Criteria:

Surgery under local anesthesia (without participation of anesthetist)
Surgery outside the operating room, such as gastrointestinal endoscopy, puncture biopsy, etc
Patients who cannot determine whether they have had SARS CoV-2 infection before surgery.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients having any type of surgery in operating room

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Diansan Su, MD,PHD	Contact	+8618616514088		diansansu@yahoo.com

Overall Officials

Name	Affiliation	Role
Diansan Su, MD,PHD	Renji Hospital, Shanghai Jiaotong University, School of Medcine	Study Chair

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007414	Intestinal Neoplasms
D008175	Lung Neoplasms
D008113	Liver Neoplasms
D014947	Wounds and Injuries
D050723	Fractures, Bone
D005831	Genital Diseases, Female

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided