Clinical trial NCT04311333: Endostomal Three-dimensional Ultrasonography for Parastomal Hernia
Official title: Endostomal Three-dimensional Ultrasonography Compared to Clinical Examination, Computerized Tomography and Intraoperative Findings for Parastomal Hernia Diagnosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parastomal Hernia
Keywords: Parastomal hernia
Ultrasound
Ultrasonography
Endostomal
Intrastomal
Colostomy
Ileostomy
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will be examined with endostomal three-dimensional ultrasonography, clinical examination and computerized tomography before undergoing laparotomy or laparoscopy
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Test characteristics
timeFrame: ≥ 1 year since stoma creation
Secondary outcomes:
Other outcomes:
Locations:
city: Luleå
country: Sweden
facility: Sunderby Hospital
state: Norrbotten County
city: Södertälje
country: Sweden
facility: Södertälje Hospital
state: Stockholm
city: Umeå
country: Sweden
facility: University Hospital of Umeå
state: Västerbotten County
Study officials:
affiliation: Department of Surgical and Perioperative Sciences, Umeå University
name: Karin Strigård
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gurmu A, Matthiessen P, Nilsson S, Pahlman L, Rutegard J, Gunnarsson U. The inter-observer reliability is very low at clinical examination of parastomal hernia. Int J Colorectal Dis. 2011 Jan;26(1):89-95. doi: 10.1007/s00384-010-1050-2. Epub 2010 Sep 7.
citation: Gurmu A, Gunnarsson U, Strigard K. Imaging of parastomal hernia using three-dimensional intrastomal ultrasonography. Br J Surg. 2011 Jul;98(7):1026-9. doi: 10.1002/bjs.7505. Epub 2011 Apr 20.
citation: Strigard K, Gurmu A, Nasvall P, Pahlman P, Gunnarsson U. Intrastomal 3D ultrasound; an inter- and intra-observer evaluation. Int J Colorectal Dis. 2013 Jan;28(1):43-7. doi: 10.1007/s00384-012-1526-3. Epub 2012 Jul 7.
citation: Nasvall P, Wikner F, Gunnarsson U, Rutegard J, Strigard K. A comparison between intrastomal 3D ultrasonography, CT scanning and findings at surgery in patients with stomal complaints. Int J Colorectal Dis. 2014 Oct;29(10):1263-6. doi: 10.1007/s00384-014-1944-5. Epub 2014 Jul 2.