A Trial to Assess the Effect and Safety of the C-Qur™ Film (CLIPEUS)
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|ClinicalTrials.gov Identifier: NCT01872650|
Recruitment Status : Unknown
Verified December 2014 by Drs. M.W.J. Stommel, University Medical Center Nijmegen.
Recruitment status was: Recruiting
First Posted : June 7, 2013
Last Update Posted : December 5, 2014
Adhesions develop in more than 90% of patients undergoing an intra-abdominal surgical leading to serious consequences and complications at reoperation.
The investigators initiate a prospective, randomized, controlled, multicenter trial to assess whether the use of C-Qur™ Film decreases the incidence of adhesion formation in subjects undergoing colorectal surgery. Treatment with the application of C-Qur™ Film as an adhesion prevention barrier for colorectal surgery will be compared with the control group at the second stage ostomy takedown procedure. The primary outcome evaluation will be assessment of adhesions to the incision site.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Adhesions||Device: C-Qur||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Controlled, Clinical Trial to Assess the Effect and Safety of the C-Qur™ fiLm, an antI-adhesive Barrier for the PrevEntion of sUrgical adhesionS|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2016|
No Intervention: Control
No placement of an adhesion barrier
C-Qur film placement beneath the incision. Possibly placement of C-Qur film at other sites considered to be adhesiogenic (but not around the anastomosis)
In subjects assigned to the treatment arm, the C-Qur™ Film must be applied beneath the incision. The C-Qur™ film can also be applied to other areas considered to be adhesiogenic (e.g. the dissection site and ostomy site but not around the anastomosis). The number of C-Qur™ Film sheets placed is limited to a maximum area of coverage of 774cm2.
- adhesions at the incision site [ Time Frame: 8-16 weeks after index surgery ]The incidence of adhesions at the incision site
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872650
|Contact: Martijn Stommel, MDfirstname.lastname@example.org|
|Contact: Chema Strik, MDemail@example.com|
|Department of Surgery, Radboud University Nijmegen Medical Center||Recruiting|
|Nijmegen, Netherlands, 6500 HB|
|Principal Investigator: Martijn Stommel, MD|
|Study Chair:||Harry van Goor, MD, PhD||Department of Surgery, Radboud University Nijmegen Medical Center|