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Endostomal Three-dimensional Ultrasonography for Parastomal Hernia

Endostomal Three-dimensional Ultrasonography Compared to Clinical Examination, Computerized Tomography and Intraoperative Findings for Parastomal Hernia Diagnosis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04311333
Acronym
CTULOP
Enrollment
100
Registered
2020-03-17
Start date
2016-09-27
Completion date
2021-12-31
Last updated
2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parastomal Hernia

Keywords

Parastomal hernia, Ultrasound, Ultrasonography, Endostomal, Intrastomal, Colostomy, Ileostomy

Brief 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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTEndostomal 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_TESTComputerized 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_TESTClinical examination

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

DIAGNOSTIC_TESTEvaluation at laparotomy/laparoscopy

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

Sponsors

Umeå University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* End colostomy or end ileostomy since ≥ 1 year * Planned for laparotomy or laparoscopy * Age ≥ 18 * Speaks and reads Swedish language * Informed consent

Exclusion criteria

* Known parastomal hernia only indication for laparotomy or laparoscopy

Design outcomes

Primary

MeasureTime frameDescription
Test characteristics≥ 1 year since stoma creationSensitivity, specificity, predictive values, likelihood ratio

Countries

Sweden

Contacts

Primary ContactJohan Nyman, M.D.
johan.nyman@umu.se(+46)90 786 46 87
Backup ContactKarin Strigård, M.D., Ph.D.
karin.strigård@umu.se(+46)90 786 46 87

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026