NCT01604837

Brief Summary

The recommended entry angle for superior hypogastric plexus block is different among references, and there is a need for suggesting a more accurate entry angle for this procedure. The investigators are trying to evaluate the entry angle for superior hypogastric plexus block by measuring these angle on the computed tomography image and apply these angle to the real patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
268

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

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

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 25, 2013

Status Verified

December 1, 2013

Enrollment Period

8 months

First QC Date

May 22, 2012

Last Update Submit

December 24, 2013

Conditions

Chronic Pelvic PainPelvic MalignancySuperior Hypogastric Plexus Block

Keywords

superior hypogastric plexus blockpelvic malignancychronic pelvic pain

Outcome Measures

Primary Outcomes (1)

  • the oblique entry angle

    the oblique entry angle of superior hypogastric plexus block at L5-S1 level

    1 month after abdominopelvic CT scan performed

Secondary Outcomes (1)

  • the axial entry angle

    1 month after abdominopelvic CT scan performed

Study Arms (2)

Pelvic malignancy group

those with diagnosis of gynecologic or urologic malignancy

Pelvic chronic disease group

those with chronic pelvic pain with constitutional cause e.g. endometriosis

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those undergoing abdominopelvic CT scan with pelvic malignancy or chronic pelvic pain with constitutional disease

You may qualify if:

  • Those undergoing abdominopelvic CT scan with pelvic malignancy or chronic pelvic pain with constitutional disease

You may not qualify if:

  • Poor CT image with non-measurable axial or oblique entry angle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Study Officials

  • Woo Seog Sim, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

  • Won Ho Kim, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

  • Hye Won Song, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 22, 2012

First Posted

May 24, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 25, 2013

Record last verified: 2013-12

Locations

KR(1)