Postoperative Adhesions Clinical Trial
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
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.
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
heavily vascularized with sensory nerve fibers. Adhesions are formed after a tissue surface
has been injured (abrasion, desiccation, lysis, etc.) and the subsequent process of
fibrinolysis is interrupted. Adhesions develop in more than 90% of patients undergoing an
intra-abdominal surgical procedure. The clinically relevant symptoms of adhesion formation
are small bowel obstruction, secondary infertility and pain. Other consequences and
complications of postsurgical intra-abdominal adhesion formation include inadvertent
enterotomy and increased dissection time due to adhesiolysis during repeat surgery. The
C-Qur™ Film offers reduction of adhesion formation and the corresponding potential
reductions in small bowel obstruction, secondary infertility, pain and incidence of
enterotomies and prolonged dissection time during subsequent abdominal surgery.
Objective:
The primary objective is to assess whether the use of C-Qur™ Film decreases the incidence of
adhesion formation in subjects undergoing colorectal surgery with a temporary loop ileostomy
or loop/split colostomy. 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.
Safety objective is to assess the number and type of post-operative complications.
Study design:
This is a prospective, physician initiated, randomized, controlled, multicenter trial.
Eligible subjects undergoing colorectal resection requiring temporary loop ileostomy or
loop/split colostomy by laparotomy or hand assisted laparoscopy will be included in the
trial. Before closure, patients are randomized 1:1 to either the treatment arm (C-Qur™ Film)
or control arm (no adhesion barrier). Subjects will return 8-16 weeks post-colorectal
resection to have their loop ileostomy or colostomy surgically taken down. During the loop
ileostomy/colostomy takedown, adhesions will be evaluated for incidence, extent, and
severity.
Study population:
Males and females 18 years of age or older, undergoing elective open or hand assisted
laparoscopic colorectal resection for any colorectal disease with the formation of a
temporary loop ileostomy or loop/split colostomy.
Intervention:
In subjects assigned to the treatment arm, the C-Qur™ Film must be applied under the
incision. Preferably it is also applied to other areas considered to be adhesiogenic, except
the anastomosis. The number of C-Qur™ Film sheets placed in the abdomen is limited to a
maximum area of coverage of 774cm2 (Please refer to Table 2 in section 6.6 for the maximum
number of sheets for each size).
Main study parameters/endpoints:
The primary endpoint is the incidence of adhesions to the incision site in subjects
undergoing colorectal surgery with a temporary loop ileostomy or loop/split colostomy.
Secondary endpoints include:
- Incidence of adhesions to the loop ileostomy or colostomy site
- Extent and severity of adhesions to the incision site
- Extent and severity of adhesions to the loop ileostomy or colostomy sites
- Duration of ileostomy takedown from the start of the takedown to the time the bowel is
repositioned in the abdomen
- Percentage (%) of abdominal wall with adhesions
Safety:
• Type and frequency of surgical and medical complications, including all types of surgical
site infections
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention