Predictive Model for PONV for Patient Received Gynecological Laparoscopic Surgery

Sponsor

Jiang Liu (Other)

Overall Status

Recruiting

CT.gov ID

NCT05757986

Collaborator

(none)

659

Enrollment

Location

5.2

Anticipated Duration (Months)

127

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting	Other: The presence of nausea and vomiting within 24 hours after surgery

Study Design

Study Type:

Observational

Anticipated Enrollment :

659 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Dynamic Predictive Model for Postoperative Nausea and Vomiting for Patient Received Gynecological Laparoscopic Surgery

Anticipated Study Start Date :

Feb 24, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental group	Other: The presence of nausea and vomiting within 24 hours after surgery This is a prospective risk prediction model building, thus there is no traditional definition of intervention.
Control group	Other: The presence of nausea and vomiting within 24 hours after surgery This is a prospective risk prediction model building, thus there is no traditional definition of intervention.

Arm

Intervention/Treatment

Experimental group

Other: The presence of nausea and vomiting within 24 hours after surgery

This is a prospective risk prediction model building, thus there is no traditional definition of intervention.

Control group

Other: The presence of nausea and vomiting within 24 hours after surgery

This is a prospective risk prediction model building, thus there is no traditional definition of intervention.

Outcome Measures

Primary Outcome Measures

PONV [Within 24 hours after surgery]
The occurrence and severity of PONV is evaluated by Visual Analogue Scale (VAS).

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weifang Medical University	Weifang	Shangdong	China	261000

Sponsors and Collaborators

Jiang Liu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiang Liu, Principal Investigator, Weifang Medical University

ClinicalTrials.gov Identifier:

NCT05757986

Other Study ID Numbers:

2023YX030

First Posted:

Mar 7, 2023

Last Update Posted:

Mar 7, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Nausea

Vomiting

Postoperative Nausea and Vomiting

Study Results

No Results Posted as of Mar 7, 2023