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

NCT01872650 | Unknown DMC

• 1 other identifier: CLIPEUS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Adhesions

Keywords

postoperative adhesions; adhesion prevention; colorectal surgery; temporary ostomy

Outcome Measures

Primary Outcomes (1)

• adhesions at the incision site

  The incidence of adhesions at the incision site

  8-16 weeks after index surgery

Study Arms (2)

Control

NO INTERVENTION

No placement of an adhesion barrier

C-Qur

EXPERIMENTAL

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

Interventions

C-Qur DEVICE

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.

C-Qur

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• University Medical Center Nijmegen: lead

Study Sites (1)

Department of Surgery, Radboud University Nijmegen Medical Center

Nijmegen, 6500 HB, Netherlands

RECRUITING

Related Publications (1)

• Stommel MW, Strik C, ten Broek RP, van Goor H. Efficacy and safety of the C-Qur Film Adhesion Barrier for the prevention of surgical adhesions (CLIPEUS Trial): study protocol for a randomized controlled trial. Trials. 2014 Sep 26;15:378. doi: 10.1186/1745-6215-15-378.

  PMID: 25260232 DERIVED

Study Officials

• Harry van Goor, MD, PhD

  Department of Surgery, Radboud University Nijmegen Medical Center

  STUDY CHAIR

Central Study Contacts

Martijn Stommel, MD

CONTACT

0031-24-3617365; m.stommel@chir.umcn.nl

Chema Strik, MD

CONTACT

0031-24-3610905; c.strik@chir.ucmn.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 7, 2013
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

NL (1)