Nausea and Vomiting After Gynecologic Surgery

January 4, 2019 updated by: Lei Li, Peking Union Medical College Hospital

Prevalence and Predictors of Nausea and Vomiting After Gynecologic Surgery: a Cross-section Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Procedure: Surgeries for gynecologic disease

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Beijing
  - Beijing, Beijing, China, 100730
    - Recruiting
    - Lei Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of post-operative nausea and vomiting by visual analogue scale Time Frame: 72 hours post-operative	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 Time Frame: 72 hours post-operative	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ANTICIPATED)

January 1, 2020

Study Completion (ANTICIPATED)

January 1, 2021

Study Registration Dates

First Submitted

January 3, 2019

First Submitted That Met QC Criteria

January 4, 2019

First Posted (ACTUAL)

January 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)