Pain Characteristics After Total Laparoscopic Hysterectomy | NCT01838382

Studies
Pain Characteristics After Total Laparoscopic Hysterectomy

NCT01838382

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Jan 14, 2014Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Myoma of Uterus

Interventions

classic LMA insertion

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

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Apr 16, 2013

First Submission Date that Met QC Criteria

Apr 23, 2013

First Posted Date

Apr 24, 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

Jan 12, 2014

Last Update Posted Date

Jan 14, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Laparoscopic operative procedures have revolutionized gynecological surgery. These have several advantages: a smaller and more cosmetic incision, reduced blood loss and shorter postoperative stay, which cuts down on hospital costs. However, postoperative pain continues to be one complication, which results in an unpleasant experience for the patient and at times causes a delayed discharge. There are few studies about pain characteristics as one of laparoscopic hysterectomy complications. The purpose of this study is to investigate the prevalence and characteristics of shoulder pain, headache, abdominal pain, and back pain in patients undergoing total laparoscopic hysterectomy.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
laparoscopic hysterectomy group	Experimental	female patients undergoing total laparoscopic hysterectomy.	Device: classic LMA insertion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
classic LMA insertion	Device	Classic LMA (cLMA) will be inserted when no response is obtained in the train-of-four stimulation. The fiberoptic view through the LMA, intraoperative complications of the cLMA, any complication during anesthesia emergence will be recorded. The device is examined and noted for the presence of visible blood.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall pain	evaluated with visual analogue score (VAS)	3 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I or II
age >=20, <= 80 years
female
patients undergoing elective total laparoscopic hysterectomy

Exclusion Criteria:

age < 19 years or > 80 years
abnormal mental status
drug abuse
chronic alcoholism
immunosuppressants or steroid user

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance hospital		Seoul	Seoul	120-752	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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