The purpose of the study is to define the accuracy of functional cine MRI detecting adhesions to the abdominal wall expressed in sensitivity, specificity, and positive and negative predictive value. In addition MRI findings of organ to organ…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The abdominal wall is divided in 9 segments for analysis.
Primary objective is Specificity and Sensitivity of functional MRI detecting
adhesions to the abdominal wall per segment.
Secondary outcome
Mapping of organ-to-organ adhesions by functional MRI and subsequent surgery
(e.g. bowel-bowel, bowel-bladder).
Background summary
Adhesions are a frequent problem in abdominal surgery. In the majority of
patients adhesions form a few days post-operative. The formation of adhesions
is part of normal wound healing, comparable to the formation of scar tissue.
However, in some patients adhesions cause severe complaints such as chronic
pain, obstruction and strangulation of the bowel. Adhesions can also obstruct
access to the peritoneal cavity and complicate reoperations. A frequent
complication is inadvertent enterotomy at trocar sites in laparoscopy.
Adhesiolysis is often necessary during reoperation. Adhesiolysis increases
operation time and the risk for complications, such as bleeding and enterotomy.
Currently, there are no diagnostic tools to map adhesions accurately. The
surgeon only becomes aware of these problems during surgery and has to adjust
operation time and procedure accordingly.
Study objective
The purpose of the study is to define the accuracy of functional cine MRI
detecting adhesions to the abdominal wall expressed in sensitivity,
specificity, and positive and negative predictive value. In addition MRI
findings of organ to organ adhesions are matched to operative findings.
Study design
Prospective multicenter observational trial.
100 Patients fulfilling the in- and exclusion criteria are asked to participate
the study. After written informed consent, the patients undergo functional cine
MRI. Radiologists are unaware of the morphology of the abdominal scars and type
of previous operations. During operation all adhesions are documented in a
standard manner. The surgeon is unaware of the results of the cine MRI. Results
are delivered independently to the investigators who will take care of
analysis.
Study burden and risks
Participation does not effect the standard treatment nor the length of hospital
stay. The extra MRI-scan causes no significant risks. The researcher will only
collect additional data on illness and medical history.
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Males and females 18 years of age and older undergoing a HIPEC-procedure for carcinomatosis peritonei.
Patients willing and capable of providing written informed consent prior to study enrollment
Patients who have had a previous laparotomy or therapeutic laparoscopy (laparoscopic adnex and/or colonic resection).
Exclusion criteria
Contra- indication for MRI (e.g. severe claustrophobia)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL21364.091.08 |