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A Trial to Assess the Effect and Safety of the C-Qur™ Film (CLIPEUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Drs. M.W.J. Stommel, University Medical Center Nijmegen

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
No Intervention: Control
No placement of an adhesion barrier
Experimental: C-Qur
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)
Device: C-Qur
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.

Primary Outcome Measures :
  1. adhesions at the incision site [ Time Frame: 8-16 weeks after index surgery ]
    The incidence of adhesions at the incision site

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients undergoing either open or hand assisted laparoscopic colonic and/or rectal resection whereby an incision is made of 6 cm or longer
  • Patients willing and capable of providing written informed consent prior to study enrolment

Exclusion Criteria:

  • Pregnant women
  • Patients for whom it is known, prior to the initial procedure, that loop ileostomy or colostomy closure between 8 and 16 weeks is not feasible for any reason
  • Patients with known/active intra-abdominal infection such as peritonitis, abdominal abscess, anastomotic leakage or fistula (Interloop abscesses in the resection specimen is not an exclusion criterion)
  • Patients with endometriosis
  • Patients with known allergies to any component of the C-Qur Film device
  • Patients requiring an additional procedure at the time of loop ileostomy or colostomy takedown deemed interfering with adhesion assessment by the treating surgeon.
  • Patients in whom it is intended to use intraoperative lavage/irrigation with any anti-adhesion solutions other than lactated ringers and/or saline (e.g. dextran, heparin, corticosteroids, ADEPT, any other irrigant that is believed to have anti-adhesion properties ) or an adhesion barrier other than C-Qur Film™.
  • Patients who have received within the last 30 days or are planned to receive systemic agents prior to the index procedure with the intention to prevent adhesion formation
  • Planned chemotherapy and/or abdominal radiotherapy between index surgery and loop ileostomy or colostomy takedown
  • Patients taking immune system suppressants deemed by the surgeon to interfere with wound healing (patients taking daily doses of corticosteroids exceeding 20mg within the prior 30 days are to be excluded). Patients requiring perioperative corticosteroid supplementation are not to be excluded.
  • Patients with impaired immune system function or coagulation disorders deemed by the surgeon to interfere with wound healing
  • Patients with a known history of severe multiple drug allergies
  • Patients who have a life expectancy of less than 6 months because of a medical condition or disease state
  • Any patient with a medical condition or other serious condition which will interfere with compliance and/or ability to complete this study protocol or who in the opinion of the investigator would not be a good candidate for enrolment
  • Patients participating in a study of another investigational device or drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01872650

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Contact: Martijn Stommel, MD 0031-24-3617365
Contact: Chema Strik, MD 0031-24-3610905

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Department of Surgery, Radboud University Nijmegen Medical Center Recruiting
Nijmegen, Netherlands, 6500 HB
Principal Investigator: Martijn Stommel, MD         
Sponsors and Collaborators
University Medical Center Nijmegen
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Study Chair: Harry van Goor, MD, PhD Department of Surgery, Radboud University Nijmegen Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Drs. M.W.J. Stommel, MD, University Medical Center Nijmegen Identifier: NCT01872650    
Other Study ID Numbers: CLIPEUS
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Keywords provided by Drs. M.W.J. Stommel, University Medical Center Nijmegen:
postoperative adhesions
adhesion prevention
colorectal surgery
temporary ostomy
Additional relevant MeSH terms:
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Tissue Adhesions
Pathologic Processes