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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03795766
Other study ID # GY-PONV
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date January 1, 2021

Study information

Verified date January 2019
Source Peking Union Medical College Hospital
Contact Lei Li
Phone +8613911988831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date January 1, 2021
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Surgeries for gynecologic disease
All patients accept surgeries for gynecologic disease.

Locations

Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of post-operative nausea and vomiting Incidence of post-operative nausea and vomiting 72 hours post-operative
Secondary 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
Secondary Severity of post-operative nausea and vomiting by World Health Organization classification Severity of post-operative nausea and vomiting according to World Health Organization (WHO) classification. In WHO classfication, I denotes none, II, III and IV denote mild, moderate and severe conditions. 72 hours post-operative
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