NCT02939443

Brief Summary

Background: The aim of this study was to investigate the efficacy of prone-position computed tomography (CT) for detecting and classifying inguinal hernia relative to supine-position CT before laparoscopic inguinal hernia repair. Materials and Methods: Sixty-eight patients who underwent laparoscopic transabdominal preperitoneal repair of inguinal hernia were enrolled in this prospective study. Patients diagnosed with inguinal hernia by physical examination underwent abdominal CT in the supine and prone positions for preoperative assessment. The anatomy of the right and left inguinal regions was confirmed during the surgery and compared with the preoperative CT findings.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
Last Updated

October 20, 2016

Status Verified

October 1, 2016

Enrollment Period

2.2 years

First QC Date

October 14, 2016

Last Update Submit

October 18, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • The detection rate of inguinal hernia

    two years

Study Arms (1)

cross-sectional study

OTHER
Radiation: supine- and prone-position Computed Tomography

Interventions

Eligibility Criteria

Age20 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • inguinal hernia

You may not qualify if:

  • emergency surgery for incarcerated hernia
  • femoral hernia
  • recurrent inguinal hernia after laparoscopic inguinal hernia repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief of surgery department

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 20, 2016

Study Start

April 1, 2014

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

October 20, 2016

Record last verified: 2016-10