Tissue AdhesionsNCT00882167
Cine-magnetic Resonance Imaging (MRI) Detecting Intra Abdominal Adhesions
An observational study of Tissue Adhesions, run by Radboud University Medical Center at 5 sites in Netherlands.
Trial summary
Official title: Sensitivity and predictive value of functional cine magnetic resonance imaging (MRI) detecting intra-abdominal adhesions Background: Adhesions are a frequent problem in abdominal surgery. The formation of adhesions is part of a normal wound healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tissue Adhesions
- What is being tested?
- CineMRI
- How many people
- 100 participants
- Where
- 5 sitesNetherlands
- Study dates
- Apr 2009to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patient who will undergo elective abdominal surgery
Who may be able to join
- Patients with a median abdominal scar due to a previous open abdominal surgical procedures with a length of at least 10 cm and have given written consent.
Who cannot join
- Severe claustrophobia.
- No MRI allowed
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Netherlands5 sites, 5 recruiting
- Not yet recruiting
Jeroen Bosch Hospital
's-Hertogenbosch
G Jager
G Jager
- Not yet recruiting
Gelre Hospital
Apeldoorn
H Buscher
H Buscher
- Not yet recruiting
Rijnstate Hospital
Arnhem, Gelderland
F Joosten, MD, PhD
F Joosten
- Not yet recruiting
Catharina Hospital
Eindhoven
I de Hingh
I de Hingh
- Recruiting
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland
R PG ten Broek, +31243619493, r.tenbroek@chir.umcn.nl
C Strik
About this study
Official title: Sensitivity and Predictive Value of Functional Cine Magnetic Resonance Imaging (MRI) Detecting Intra-abdominal Adhesions
Official title:
Sensitivity and predictive value of functional cine magnetic resonance imaging (MRI) detecting intra-abdominal adhesions
Read more
Background:
Adhesions are a frequent problem in abdominal surgery. The formation of adhesions is part of a normal wound healing. However in some patients adhesions cause severe complications such as chronic pain, obstruction and strangulation of the bowel. Adhesions can also obstruct access to the peritoneal cavity and complicate reoperations. Accurate imaging of adhesions would be of benefit avoiding adhesion related complications at repeated laparotomy or laparoscopy. At present no validated diagnostic tool mapping adhesions exists.
Purpose:
To define the sensitivity and specificity of functional cineMRI in detecting and mapping adhesions in patients undergoing reoperation.
Design:
Prospective multicenter observational trial
Primary outcome:
Sensitivity and specificity of functional MRI detecting adhesions to the abdominal wall
Secondary outcome:
Sensitivity and specificity of functional MRI detecting organ-to-organ adhesions.
Estimated enrollment: 100
Estimated study completion date: dec 2019
Estimated primary completion date: dec 2019
- Conditions
- Tissue Adhesions
- Being tested
- CineMRI
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CineMRIOther
CineMRI scan of the abdomen at 1.5 Tesla.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with laparotomy in history Receives: Other: CineMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity
diagnsotic accuracy for detecting adhesions
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tissue AdhesionsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harry van Goor, MD, PhD, Study director, Radboud University Nijmegen Medical CenterRichard PG ten Broek, Principal investigator, Radboud University Nijmegen Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882167
- Sponsor's protocol ID
- RU-RTB-0001
- Status last verified
- Dec 2024
- First submitted
- 15 Apr 2009
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
van Goor H. Consequences and complications of peritoneal adhesions. Colorectal Dis. 2007 Oct;9 Suppl 2:25-34. doi: 10.1111/j.1463-1318.2007.01358.x.
PubMed 17824967Lienemann A, Sprenger D, Steitz HO, Korell M, Reiser M. Detection and mapping of intraabdominal adhesions by using functional cine MR imaging: preliminary results. Radiology. 2000 Nov;217(2):421-5. doi: 10.1148/radiology.217.2.r00oc23421.
PubMed 11058638Mussack T, Fischer T, Ladurner R, Gangkofer A, Bensler S, Hallfeldt KK, Reiser M, Lienemann A. Cine magnetic resonance imaging vs high-resolution ultrasonography for detection of adhesions after laparoscopic and open incisional hernia repair: a matched pair pilot analysis. Surg Endosc. 2005 Dec;19(12):1538-43. doi: 10.1007/s00464-005-0092-y. Epub 2005 Oct 24.
PubMed 16247569
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Predictive Value of Functional Cine Magnetic Resonance Imaging (MRI) Detecting Intra-abdominal Adhesions
- ClinicalTrials.gov ID
- NCT00882167
- Acronym / sponsor ID
- RU-RTB-0001
- Conditions
- Tissue Adhesions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Apr 2009 (estimated)
- 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.
Official title:
Sensitivity and predictive value of functional cine magnetic resonance imaging (MRI) detecting intra-abdominal adhesions
Background:
Adhesions are a frequent problem in abdominal surgery. The formation of adhesions is part of a normal wound healing. However in some patients adhesions cause severe complications such as chronic pain, obstruction and strangulation of the bowel. Adhesions can also obstruct access to the peritoneal cavity and complicate reoperations. Accurate imaging of adhesions would be of benefit avoiding adhesion related complications at repeated laparotomy or laparoscopy. At present no validated diagnostic tool mapping adhesions exists.
Purpose:
To define the sensitivity and specificity of functional cineMRI in detecting and mapping adhesions in patients undergoing reoperation.
Design:
Prospective multicenter observational trial
Primary outcome:
Sensitivity and specificity of functional MRI detecting adhesions to the abdominal wall
Secondary outcome:
Sensitivity and specificity of functional MRI detecting organ-to-organ adhesions.
Estimated enrollment: 100
Estimated study completion date: dec 2019
Estimated primary completion date: dec 2019
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: CineMRIPatients with laparotomy in history |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who will undergo elective abdominal surgery
Key inclusion criteria (1 listed)
- Patients with a median abdominal scar due to a previous open abdominal surgical procedures with a length of at least 10 cm and have given written consent.
Key exclusion criteria (2 listed)
- Severe claustrophobia.
- No MRI allowed
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 |
|---|---|---|
| CineMRICineMRI scan of the abdomen at 1.5 Tesla. | Other | 1 |
Primary outcome
Sensitivity and specificity
Time frame: 2 weeks
diagnsotic accuracy for detecting adhesions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Background: PubMed 17824967van Goor H. Consequences and complications of peritoneal adhesions. Colorectal Dis. 2007 Oct;9 Suppl 2:25-34. doi: 10.1111/j.1463-1318.2007.01358.x.
- Background: PubMed 11058638Lienemann A, Sprenger D, Steitz HO, Korell M, Reiser M. Detection and mapping of intraabdominal adhesions by using functional cine MR imaging: preliminary results. Radiology. 2000 Nov;217(2):421-5. doi: 10.1148/radiology.217.2.r00oc23421.
- Background: PubMed 16247569Mussack T, Fischer T, Ladurner R, Gangkofer A, Bensler S, Hallfeldt KK, Reiser M, Lienemann A. Cine magnetic resonance imaging vs high-resolution ultrasonography for detection of adhesions after laparoscopic and open incisional hernia repair: a matched pair pilot analysis. Surg Endosc. 2005 Dec;19(12):1538-43. doi: 10.1007/s00464-005-0092-y. Epub 2005 Oct 24.
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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.
Harry van Goor, MD, PhD study director
Radboud University Nijmegen Medical Center
Richard PG ten Broek principal investigator
Radboud University Nijmegen Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tissue Adhesions, run by Radboud University Medical Center at 5 sites in Netherlands.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard ten Broek (+31243619493, r.tenbroek@chir.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity (time frame: 2 weeks). 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 NCT00882167, which also lists 3 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 15 Jan 2025.