Endostomal Three-dimensional Ultrasonography for Parastomal Hernia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-27

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Parastomal hernia (PSH) is one of the most common stoma complications, with an incidence of 30-50 % within just a couple of years of stoma creation. Surgical parastomal hernia repair is a morbid and complicated procedure, with a 30-day reoperation rate of 13 % and 30-day mortality rate of 6 % in population-based surveys. There is no established gold standard diagnostic modality. Routinely, patients are examined clinically in various positions with and without increased intra-abdominal pressure. It has been shown in previous studies that clinical examination has a very low inter-observer reliability. Computerized tomography is often performed in addition to clinical examination, but is not ideal in diagnosing PSH either, not only beacause of insufficient test characteristics but also since the examinations should ideally be performed with specific protocols, prone position and be reviewed by a dedicated radiologist. The risk of incorrectly diagnosing a PSH (false positive) is that patients might subsequently be exposed to complex and dangerous surgical interventions without any health benefit, while incorrectly ruling out a PSH (false negative) can cause the patient to have to live with potentially treatable symptoms, life-threatening bowel incarceration being the most severe potential complication.

Thus, improved diagnostic accuracy is required. A method that has been developed within our research group is endostomal tree-dimensional ultrasonography, which has preliminarily proven to be approximately as sensitive as CT, with a markedly higher specificity. A larger and less selected study needs to be conducted in order to reliably calculate test characteristics, predictive values and likelihood ratio.

Conditions

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Parastomal Hernia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All patients will be examined with endostomal three-dimensional ultrasonography, clinical examination and computerized tomography before undergoing laparotomy or laparoscopy

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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All patients

All patients undergo endostomal three-dimensional ultrasonography, computerized tomography, clinical examination and laparotomy/laparoscopy.

At all the respective examinations, the presence of a parastomal hernia as well as hernia location and size is evaluated.

Group Type EXPERIMENTAL