Parastomal HerniaCTULOPNCT04311333
Endostomal Three-dimensional Ultrasonography for Parastomal Hernia
A study testing Endostomal three-dimensional ultrasonography, Computerized tomography of the abdomen and Clinical examination in people with Parastomal Hernia, run by Umeå University at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- Endostomal three-dimensional ultrasonography, Computerized tomography of the abdomen and Clinical examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesSweden
- Study dates
- 27 Sep 2016to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End colostomy or end ileostomy since ≥ 1 year
- Planned for laparotomy or laparoscopy
- Age ≥ 18
- Speaks and reads Swedish language
- Informed consent
Who cannot join
- Known parastomal hernia only indication for laparotomy or laparoscopy
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites, 3 recruiting
- Recruiting
Sunderby Hospital
Luleå, Norrbotten County, 971 80
Johan Nyman, M.D., +46727436345, johan.nyman@umu.se
Karin Strigård, M.D., Ph.D., +46907864687, karin.strigard@umu.se
- Not yet recruiting
Södertälje Hospital
Södertälje, Stockholm County, 152 86
Fredrik Brännström, M.D., Ph.D., +46855024000, fredrikbrannstrom@yahoo.se
- Recruiting
University Hospital of Umeå
Umeå, Västerbotten County, 907 37
Johan Nyman, M.D., +46727436345, johan.nyman@umu.se
Karin Strigård, M.D., Ph.D., +46907864687, karin.strigard@umu.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Parastomal Hernia
- Being tested
- Endostomal three-dimensional ultrasonography, Computerized tomography of the abdomen, Clinical examination, Evaluation at laparotomy/laparoscopy
- Keywords
- Parastomal hernia, Ultrasound, Ultrasonography, Endostomal, Intrastomal, Colostomy, Ileostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endostomal three-dimensional ultrasonographyDiagnostic test
Examination with rectal probe enclosed by water-filled balloon. Rectal mode. Dynamic examination in different positions with and without increased intra-abdominal pressure.
Computerized tomography of the abdomenDiagnostic test
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.
Clinical examinationDiagnostic test
Patients will be clinically examined with inspection and palpation in supine and erect position with and without increased intra-abdominal pressure.
Evaluation at laparotomy/laparoscopyDiagnostic test
During laparotomy or laparoscopy, inspection and/or palpation of the stoma at the abdominal wall orifice is performed.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | 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. Receives: Diagnostic Test: Endostomal three-dimensional ultrasonography; Diagnostic Test: Computerized tomography of the abdomen; Diagnostic Test: Clinical examination; Diagnostic Test: Evaluation at laparotomy/laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test characteristics
Sensitivity, specificity, predictive values, likelihood ratio
Measured: ≥ 1 year since stoma creation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start27 Sep 2016
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parastomal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will be examined with endostomal three-dimensional ultrasonography, clinical examination and computerized tomography before undergoing laparotomy or laparoscopy
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karin Strigård, Principal investigator, Department of Surgical and Perioperative Sciences, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311333
- Sponsor's protocol ID
- CTULOP
- Acronym
- CTULOP
- Status last verified
- Nov 2020
- First submitted
- 12 Mar 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20821218Gurmu 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.
PubMed 21509751Strigard 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.
PubMed 22772711Nasvall 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.
PubMed 24986139
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endostomal Three-dimensional Ultrasonography Compared to Clinical Examination, Computerized Tomography and Intraoperative Findings for Parastomal Hernia Diagnosis
- ClinicalTrials.gov ID
- NCT04311333
- Acronym / sponsor ID
- CTULOP / CTULOP
- Conditions
- Parastomal Hernia
- Keywords
- Parastomal hernia, Ultrasound, Ultrasonography, Endostomal, Intrastomal, Colostomy, Ileostomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will be examined with endostomal three-dimensional ultrasonography, clinical examination and computerized tomography before undergoing laparotomy or laparoscopy
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Diagnostic Test: Endostomal three-dimensional ultrasonography, Diagnostic Test: Computerized tomography of the abdomen, Diagnostic Test: Clinical examination, Diagnostic Test: Evaluation at laparotomy/laparoscopyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- End colostomy or end ileostomy since ≥ 1 year
- Planned for laparotomy or laparoscopy
- Age ≥ 18
- Speaks and reads Swedish language
- Informed consent
Key exclusion criteria (1 listed)
- Known parastomal hernia only indication for laparotomy or laparoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endostomal three-dimensional ultrasonographyExamination with rectal probe enclosed by water-filled balloon. Rectal mode. Dynamic examination in different positions with and without increased intra-abdominal pressure. | Diagnostic test | All patients |
| Computerized tomography of the abdomenSupine 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 | All patients |
| Clinical examinationPatients will be clinically examined with inspection and palpation in supine and erect position with and without increased intra-abdominal pressure. | Diagnostic test | All patients |
| Evaluation at laparotomy/laparoscopyDuring laparotomy or laparoscopy, inspection and/or palpation of the stoma at the abdominal wall orifice is performed. | Diagnostic test | All patients |
Primary outcome
Test characteristics
Time frame: ≥ 1 year since stoma creation
Sensitivity, specificity, predictive values, likelihood ratio
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 20821218Gurmu 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.
- Background: PubMed 21509751Gurmu 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.
- Background: PubMed 22772711Strigard 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.
- Background: PubMed 24986139Nasvall 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Strigård principal investigator
Department of Surgical and Perioperative Sciences, Umeå University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endostomal three-dimensional ultrasonography, Computerized tomography of the abdomen and Clinical examination in people with Parastomal Hernia, run by Umeå University at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan Nyman, M.D. ((+46)90 786 46 87, johan.nyman@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test characteristics (time frame: ≥ 1 year since stoma creation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04311333, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.