NCT03703752

Brief Summary

Researchers retrospectively reviewed patients with internal hernia that confirmed by surgical exploration between Feb. 2012 and Feb. 2018. and analysis the Medical records and MDCT images to investigate the clinical and radiological features of internal hernia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

October 9, 2018

Last Update Submit

October 11, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • CT features

    MDCT features of IH were assessed for the following findings: (1) Demonstration of bowels dislocation in IH: dislocated cluster of the intestinal segments; crowding or convergence of mesenteric vessels; (2) Demonstration of obstruction or ischemia: bowel wall thickening or abnormal enhancement; dilated bowels with abnormal free fluid; twisted bowels with swirl sign of vessels. (3) Demonstration of specific signs: hernial orifice and closed-loop of intestine; fat notch sign.

    2 weeks

Study Arms (2)

Adhesive IH

Adhesive IH can further be divided into primary or secondary groups according to the history of abdominal and(or) pelvic surgery

Diagnostic Test: Multi-detector CT scan

non-adhesive IH

Non-adhesive IH means the IH resulting from the abnormality of peritoneal structure.

Diagnostic Test: Multi-detector CT scan

Interventions

Multi-detector CT scanDIAGNOSTIC_TEST

This is a diagnostic radiological test to diagnose the IH and evaluate the clinical condition of IH

Adhesive IHnon-adhesive IH

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All Patients with definite diagnosis of IH during surgical exploration from Feb. 2012 to Feb. 2018 in our hospital were included in this research

You may qualify if:

  • IH confirmed by surgical exploration

You may not qualify if:

  • diaphragmatic hernia and traumatic IH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 12, 2018

Study Start

February 20, 2018

Primary Completion

June 20, 2018

Study Completion

June 20, 2018

Last Updated

October 12, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations