Postoperative AdhesionsCLIPEUSNCT01872650
A Trial to Assess the Effect and Safety of the C-Qur™ Film
A study testing C-Qur in people with Postoperative Adhesions, run by University Medical Center Nijmegen at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Adhesions
- What is being tested?
- C-Qur
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Department of Surgery, Radboud University Nijmegen Medical Center
Nijmegen, 6500 HB
Martijn Stommel, MD
About this study
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.
Read the 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 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
- Conditions
- Postoperative Adhesions
- Being tested
- C-Qur
- Keywords
- postoperative adhesions, adhesion prevention, colorectal surgery, temporary ostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-QurDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: C-Qur |
What is being measured
The primary outcome is the main question the study is designed to answer.
adhesions at the incision site
The incidence of adhesions at the incision site
Measured: 8-16 weeks after index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startSep 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative AdhesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Nijmegen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Drs. M.W.J. Stommel, University Medical Center Nijmegen
- Investigators
- Harry van Goor, MD, PhD, Study chair, Department of Surgery, Radboud University Nijmegen Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872650
- Sponsor's protocol ID
- CLIPEUS
- Acronym
- CLIPEUS
- Status last verified
- Dec 2014
- First submitted
- 4 Jun 2013
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25260232
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01872650
- Acronym / sponsor ID
- CLIPEUS / CLIPEUS
- Conditions
- Postoperative Adhesions
- Keywords
- postoperative adhesions, adhesion prevention, colorectal surgery, temporary ostomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Medical Center NijmegenUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No placement of an adhesion barrier |
| C-Qur | Experimental | Device: C-QurC-Qur film placement beneath the incision. Possibly placement of C-Qur film at other sites considered to be adhesiogenic (but not around the anastomosis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-QurIn 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. | Device | C-Qur |
Primary outcome
adhesions at the incision site
Time frame: 8-16 weeks after index surgery
The incidence of adhesions at the incision site
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Derived from this study: PubMed 25260232Stommel 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.
Related trials for Postoperative Adhesions
Recruiting
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
Myoma
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Not yet recruiting
Abdominopelvic Fascial Release for Post-Cesarean Menstrual Pain and Scar Mobility
Dysmenorrhea, Cesarean Section
Active, not recruitingObservational study
Effects of HIPEC on Postoperative Bowel Motility and Complications
HIPEC, Gastro Intestinal Cancer
Not yet recruitingObservational study
Safety and Performance of the Semical Adhesion Barrier Gel for Prevention of Intra-uterine Adhesion
Intrauterine Abnormalities in Infertility, Asherman Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry van Goor, MD, PhD study chair
Department of Surgery, Radboud University Nijmegen Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-Qur in people with Postoperative Adhesions, run by University Medical Center Nijmegen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martijn Stommel, MD (0031-24-3617365, m.stommel@chir.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adhesions at the incision site (time frame: 8-16 weeks after index surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01872650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.