Predictive Model for PONV for Patient Received Gynecologi... | NCT05757986

Studies
Predictive Model for PONV for Patient Received Gynecological Laparoscopic Surgery

NCT05757986

Sponsor

Jiang Liu

Status

Unknown status

Last Update Posted

Jun 15, 2023Actual

Enrollment

659Estimated

Phase

Not provided

Conditions

Postoperative Nausea and Vomiting

Interventions

The presence of nausea and vomiting within 24 hours after surgery

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

Jun 2023

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

Sep 1, 2022Actual

Primary Completion Date

Mar 1, 2023Actual

Completion Date

Oct 1, 2023Estimated

First Submitted Date

Feb 22, 2023

First Submission Date that Met QC Criteria

Mar 3, 2023

First Posted Date

Mar 7, 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

Jun 13, 2023

Last Update Posted Date

Jun 15, 2023Actual

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

This is a prospective study to dynamically predict the risk of PONV in patients undergoing gynecologic laparoscopic surgery.

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

659Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental group			Other: The presence of nausea and vomiting within 24 hours after surgery
Control group			Other: The presence of nausea and vomiting within 24 hours after surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The presence of nausea and vomiting within 24 hours after surgery	Other	This is a prospective risk prediction model building, thus there is no traditional definition of intervention.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PONV	The occurrence and severity of PONV is evaluated by Visual Analogue Scale (VAS).	Within 24 hours after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-All female patients receiving gynecological laparoscopic surgery.

Exclusion Criteria:

-Patients requiring intraoperative open-surgery, requiring other procedures in addition to gynecological laparoscopy, with severe organ dysfunction, unstable postoperative vital signs or requiring transfer to ICU.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

The objective of this study was to develop a risk prediction model for postoperative nausea and vomiting in patients undergoing gynecologic laparoscopic surgery. Therefore, the target population of this study was limited to female patients with gynecologic diseases and requiring gynecologic laparoscopic surgery.

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The female patients with gynecological diseases and requiring gynecological laparoscopic surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
YuXiu Liu, Ph.D	Contact	+8618663608162		18663608162@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Weifang Medical University	Recruiting	Weifang	Shangdong	261000	China

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
D011184	Postoperative Period

Ancestor Terms

ID	Term
D059035	Perioperative Period
D013514	Surgical Procedures, Operative
D005791	Patient Care
D006296	Health Services

Browse Leaves

Not provided

Browse Branches

Not provided