Long Term Prevention of Nausea and Vomiting in Gynecologi... | NCT02011659

Studies
Long Term Prevention of Nausea and Vomiting in Gynecologic Laparoscopy

NCT02011659

Sponsor

National Health Insurance Service Ilsan Hospital

Status

Unknown status

Last Update Posted

Dec 13, 2013Estimated

Enrollment

128Estimated

Phase

Phase 3

Conditions

Uterine Myoma, Ovary Neoplasm, Adenomyosis

Interventions

Ramosetron

Countries

South Korea

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

Dec 2013

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

Nov 2013

Primary Completion Date

Nov 2015Estimated

Completion Date

Not provided

First Submitted Date

Dec 10, 2013

First Submission Date that Met QC Criteria

Dec 12, 2013

First Posted Date

Dec 13, 2013Estimated

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

Dec 12, 2013

Last Update Posted Date

Dec 13, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

San-Hui Lee, Clinical assistant professor, National Health Insurance Service Ilsan HospitalPrincipal Investigator

Lead Sponsor

National Health Insurance Service Ilsan HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To compare postoperative nausea and vomiting (PONV) and perioperative outcomes of gynecologic patients undergoing laparoscopic surgery after scheduled administration of intravenous Ramosetron during hospital stays.

Randomized controlled arm : Placebo versus Ramosetron injection
Administration schedule : immediate postoperative status, 12 hrs after surgery, 36hrs after surgery

Detailed Description

Surgical outcomes including operative time, blood loss, Hb change, postoperative pain, nausea/vomiting scale, times of rescue therapy, and complications

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

128Estimated

Label	Type	Description	Intervention Names
Ramosetron	Active Comparator		Drug: Ramosetron

Name	Type	Description	Arm Group Labels	Other Names
Ramosetron	Drug		Ramosetron

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence or intensity of PONV		during postoperative hospital stays (2 days)

Secondary Outcomes

Measure	Description	Time Frame
Adverse reaction associated with Ramosetron injection		Postoperatvie 7 days (at OPD based)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 18< or =, = or <70 with benign gynecologic disease
ASA-Class I-II
No-definite malignancy by US, CT/MRI, CA 125 < 500IU/ml
Non-smoker

Exclusion Criteria:

Conversion to laparotomy
Hx of malignancy
Smoker
Suspicious malignancy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
San-Hui Lee, M.D.	Contact	+82-900-0218		sanaram@naver.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Health Insurance Service Ilsan Hospital	Recruiting	Goyang-si		410-719	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31538078	Derived	Li SC, Wang Y, Choi SJ, Jung YS, Han KH, Chung IB, Lee SH. Scheduled injection of ramosetron for prevention of nausea and vomiting following single-port access total laparoscopic hysterectomy: a prospective randomized study. Obstet Gynecol Sci. 2019 Sep;62(5):344-351. doi: 10.5468/ogs.2019.62.5.344. Epub 2019 Jul 23.

ID	Term
D047708	Myofibroma
D010051	Ovarian Neoplasms
D062788	Adenomyosis
D020250	Postoperative Nausea and Vomiting
D014839	Vomiting

ID	Term
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms