Nausea and Vomiting After Gynecologic Surgery | NCT03795766

Studies
Nausea and Vomiting After Gynecologic Surgery

NCT03795766

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Jan 8, 2019Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Postoperative Nausea and Vomiting
Gynecologic Surgery

Interventions

Surgeries for gynecologic disease

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jan 1, 2020Estimated

Completion Date

Jan 1, 2021Estimated

First Submitted Date

Jan 3, 2019

First Submission Date that Met QC Criteria

Jan 4, 2019

First Posted Date

Jan 8, 2019Actual

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

Jan 4, 2019

Last Update Posted Date

Jan 8, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lei Li, Professor, Peking Union Medical College HospitalPrincipal Investigator

Lead Sponsor

Peking Union Medical College HospitalOTHER

Collaborators

Not provided

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

In this cross-section study, all patients in the gynecologic ward of Peking Union Medical College Hospital will accepted a survey about the prevalence and severity of nausea and vomiting according to visual analogue scale and WHO classification. Epidemiological, surgical, anaesthetic characteristics and post-operative treatment are considered as predictors for the post-operative nausea and vomiting. The primary objective is the incidence of nausea and vomiting. The secondary objective is the possible predictors of nausea and vomiting.

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

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgeries for gynecologic disease	Procedure	All patients accept surgeries for gynecologic disease.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of post-operative nausea and vomiting	Incidence of post-operative nausea and vomiting	72 hours post-operative

Secondary Outcomes

Measure	Description	Time Frame
Severity of post-operative nausea and vomiting by visual analogue scale	Severity of post-operative nausea and vomiting according to the visual analogue scale. In th scale, 0 denotes none, 10 denotes the most severe conditions. The scale will be judged by the patients.	72 hours post-operative
Severity of post-operative nausea and vomiting by World Health Organization classification

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18 years or older
Elective surgeries for gynecologic disease
Good performance status
Signed an approved informed consents
Post-operative stay 72 hours or longer

Exclusion Criteria:

Emergency surgeries
Not meeting all of the inclusion criteria

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients accept elective surgeries for gynecologic disease with good performance status.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lei Li	Contact	+8613911988831		lileigh@163.com

Overall Officials

Name	Affiliation	Role
Lei Li, M.D.	Peking Union Medical College Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lei Li	Recruiting	Beijing	Beijing Municipality	100730	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009325	Nausea

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided