Endostomal Three-dimensional Ultrasonography for Parastomal Hernia (CTULOP)

November 2, 2020 updated by: Umeå University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
    • Norrbotten County
      • Luleå, Norrbotten County, Sweden, 971 80
        • Recruiting
        • Sunderby Hospital
        • Contact:
        • Contact:
    • Stockholm
      • Södertälje, Stockholm, Sweden, 152 86
        • Not yet recruiting
        • Södertälje Hospital
        • Contact:
    • Västerbotten County
      • Umeå, Västerbotten County, Sweden, 907 37
        • Recruiting
        • University Hospital of Umeå
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test characteristics
Time Frame: ≥ 1 year since stoma creation
Sensitivity, specificity, predictive values, likelihood ratio
≥ 1 year since stoma creation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Principal Investigator: Karin Strigård, Department of Surgical and Perioperative Sciences, Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2016

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

March 12, 2020

First Submitted That Met QC Criteria

March 12, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTULOP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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