NCT01838382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

6 months

First QC Date

April 16, 2013

Last Update Submit

January 12, 2014

Conditions

Myoma of Uterus

Keywords

paintotal laparoscopic hysterectomy

Outcome Measures

Primary Outcomes (1)

  • overall pain

    evaluated with visual analogue score (VAS)

    3 days

Study Arms (1)

laparoscopic hysterectomy group

EXPERIMENTAL

female patients undergoing total laparoscopic hysterectomy.

Device: classic LMA insertion

Interventions

classic LMA insertionDEVICE

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.

laparoscopic hysterectomy group

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2013

First Posted

April 24, 2013

Study Start

March 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

KR(1)