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Trial record 10 of 122 for:    Recruiting, Not yet recruiting, Available Studies | Nausea and vomiting

Nausea and Vomiting After Gynecologic Surgery

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ClinicalTrials.gov Identifier: NCT03795766
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment
Postoperative Nausea and Vomiting Gynecologic Surgery Procedure: Surgeries for gynecologic disease

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Predictors of Nausea and Vomiting After Gynecologic Surgery: a Cross-section Study
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Surgeries for gynecologic disease
    All patients accept surgeries for gynecologic disease.


Primary Outcome Measures :
  1. Incidence of post-operative nausea and vomiting [ Time Frame: 72 hours post-operative ]
    Incidence of post-operative nausea and vomiting


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients accept elective surgeries for gynecologic disease with good performance status.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795766


Contacts
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Contact: Lei Li +8613911988831 lileigh@163.com

Locations
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China, Beijing
Lei Li Recruiting
Beijing, Beijing, China, 100730
Contact: Lei Li, MD    008613911988831    lileigh@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Lei Li, M.D. Peking Union Medical College Hospital

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Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03795766     History of Changes
Other Study ID Numbers: GY-PONV
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes