Status:
UNKNOWN
A Trial to Assess the Effect and Safety of the C-Qur™ Film
Lead Sponsor:
University Medical Center Nijmegen
Conditions:
Postoperative Adhesions
Eligibility:
All Genders
18+ years
Phase:
NA
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, rando...
Detailed Description
Rationale: Adhesions are fibrous bands that connect tissue surfaces where anatomical connections do not normally exist. Adhesion tenacity appears to be related to maturity, as they can be filmy or he...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01872650
Start Date
September 1 2014
End Date
December 1 2016
Last Update
December 5 2014
Active Locations (1)
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1
Department of Surgery, Radboud University Nijmegen Medical Center
Nijmegen, Netherlands, 6500 HB