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Endostomal Three-dimensional Ultrasonography for Parastomal Hernia

NCT04311333 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-11-04

No results posted yet for this study

Summary

The intention is to examine the role of ultrasonographic examination inside intestinal stomas in diagnosing parastomal hernia. Patients with a stoma since at least one year back who are being scheduled for abdominal surgery will be examined for eligibility according to the selection criteria. Included patients will undergo routine clinical examination, endostomal ultrasonography and computerized tomography scan of the abdomen. Findings will be correlated to findings during surgery (gold standard). Values for sensitivity, specificity, predictive values and likelihood ratio will be calculated.

Conditions

  • Parastomal Hernia

Interventions

DIAGNOSTIC_TEST

Endostomal three-dimensional ultrasonography

Examination with rectal probe enclosed by water-filled balloon. Rectal mode. Dynamic examination in different positions with and without increased intra-abdominal pressure.

DIAGNOSTIC_TEST

Computerized tomography of the abdomen

Supine position, without increased intra-abdominal pressure. Experienced radiologist interprets the examination. If adequate examination has already been performed within the last 10 months, these images will be used and the patient will thus not undergo computerized tomography within the study.

DIAGNOSTIC_TEST

Clinical examination

Patients will be clinically examined with inspection and palpation in supine and erect position with and without increased intra-abdominal pressure.

DIAGNOSTIC_TEST

Evaluation at laparotomy/laparoscopy

During laparotomy or laparoscopy, inspection and/or palpation of the stoma at the abdominal wall orifice is performed.

Sponsors & Collaborators

  • Umeå University

    lead OTHER

Principal Investigators

  • Karin Strigård · Department of Surgical and Perioperative Sciences, Umeå University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-27
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04311333 on ClinicalTrials.gov