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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.

Stommel MW, Strik C, ten Broek RP, van Goor H - Trials (2014)

Bottom Line: This agent has limitations through poor handling characteristics because it is sticky on both sides.C-Qur™ Film is a novel thin film adhesion barrier and it is sticky on only one side, resulting in better handling characteristics.Results of this study add to the evidence on the use of anti-adhesive barriers in open and laparoscopic 'hand-assisted' colorectal surgery.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Radboud University Medical Center, P,O, Box 9101, 6500 HB Nijmegen, The Netherlands. Martijn.Stommel@radboudumc.nl.

ABSTRACT

Background: Adhesions develop in over 90% of patients after intra-abdominal surgery. Adhesion barriers are rarely used despite the high morbidity caused by intra-abdominal adhesions. Only one of the currently available adhesion barriers has demonstrated consistent evidence for reducing adhesions in visceral surgery. This agent has limitations through poor handling characteristics because it is sticky on both sides. C-Qur™ Film is a novel thin film adhesion barrier and it is sticky on only one side, resulting in better handling characteristics. The objective of this study is to assess efficacy and safety of C-Qur™ Film to decrease the incidence of adhesions after colorectal surgery.

Methods/design: This is a prospective, investigator initiated, randomized, double-blinded, multicenter trial. Eligible patients 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). Patients will return 8 to 16 weeks post-colorectal resection for take down of their ostomy. During ostomy takedown, adhesions will be evaluated for incidence, extent, and severity. The primary outcome evaluation will be assessment of adhesions to the incision site. It is hypothesized that the use of C-Qur™ Film underneath the primary incision reduces the incidence of adhesion at the incision by 30%. To demonstrate 30% reduction in the incidence of adhesions, a sample size of 84 patients (32 + 10 per group (25% drop out)) is required (two-sided test, α = 0.05, 80% power).

Discussion: Results of this study add to the evidence on the use of anti-adhesive barriers in open and laparoscopic 'hand-assisted' colorectal surgery. We chose incidence of adhesions to the incision site as primary outcome measure since clinical outcomes such as small bowel obstruction, secondary infertility and adhesiolysis related complications are considered multifactorial and difficult to interpret. Incidence of adhesions at repeat surgery is believed to be the most valuable surrogate endpoint for clinically relevant adhesion prevention, since small bowel obstruction and adhesiolysis at repeat surgery are not likely to occur when complete adhesion reduction in a patient is accomplished.

Trial registration: ClinicalTrials.gov Identifier NCT01872650, registration date 6 June 2013.

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Related in: MedlinePlus

Quadrants of the ostomy site.
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Fig2: Quadrants of the ostomy site.

Mentions: Patients in both groups will undergo the same procedure for ostomy closure. To evaluate the adhesions at the loop ileostomy/colostomy site, the incidence, severity and extent of adhesions around the ostomy have to be evaluated during takedown. The time required for takedown of the ostomy is defined as the time from start of the takedown to the time the bowel is repositioned in the abdomen, and this time will be noted on the CRF. The severity of adhesions will be scored according to the Zühlke classification (see Table 2). To assess the extent of adhesions, the ostomy is divided in four quadrants (Figure 2). The extent of adhesions is scored as the number of quadrants containing adhesions (Table 3). After the ileostomy/colostomy takedown is completed, the surgeon will introduce a laparoscope at the ostomy site and evaluate the incidence, extent and severity of adhesions at the incision site and at other areas potentially injured (and covered) during the initial procedure. The severity will be scored according to the Zühlke classification (see Table 2). The extent of adhesions underneath the incision site will be scored through estimation of the area covered by adhesions as a percentage of the total area underneath the incision. The incidence and severity of adhesions at other areas potentially injured during the initial procedure will be scored according to the Zühlke classification (see Table 2).Figure 2


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.

Stommel MW, Strik C, ten Broek RP, van Goor H - Trials (2014)

Quadrants of the ostomy site.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4195905&req=5

Fig2: Quadrants of the ostomy site.
Mentions: Patients in both groups will undergo the same procedure for ostomy closure. To evaluate the adhesions at the loop ileostomy/colostomy site, the incidence, severity and extent of adhesions around the ostomy have to be evaluated during takedown. The time required for takedown of the ostomy is defined as the time from start of the takedown to the time the bowel is repositioned in the abdomen, and this time will be noted on the CRF. The severity of adhesions will be scored according to the Zühlke classification (see Table 2). To assess the extent of adhesions, the ostomy is divided in four quadrants (Figure 2). The extent of adhesions is scored as the number of quadrants containing adhesions (Table 3). After the ileostomy/colostomy takedown is completed, the surgeon will introduce a laparoscope at the ostomy site and evaluate the incidence, extent and severity of adhesions at the incision site and at other areas potentially injured (and covered) during the initial procedure. The severity will be scored according to the Zühlke classification (see Table 2). The extent of adhesions underneath the incision site will be scored through estimation of the area covered by adhesions as a percentage of the total area underneath the incision. The incidence and severity of adhesions at other areas potentially injured during the initial procedure will be scored according to the Zühlke classification (see Table 2).Figure 2

Bottom Line: This agent has limitations through poor handling characteristics because it is sticky on both sides.C-Qur™ Film is a novel thin film adhesion barrier and it is sticky on only one side, resulting in better handling characteristics.Results of this study add to the evidence on the use of anti-adhesive barriers in open and laparoscopic 'hand-assisted' colorectal surgery.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Radboud University Medical Center, P,O, Box 9101, 6500 HB Nijmegen, The Netherlands. Martijn.Stommel@radboudumc.nl.

ABSTRACT

Background: Adhesions develop in over 90% of patients after intra-abdominal surgery. Adhesion barriers are rarely used despite the high morbidity caused by intra-abdominal adhesions. Only one of the currently available adhesion barriers has demonstrated consistent evidence for reducing adhesions in visceral surgery. This agent has limitations through poor handling characteristics because it is sticky on both sides. C-Qur™ Film is a novel thin film adhesion barrier and it is sticky on only one side, resulting in better handling characteristics. The objective of this study is to assess efficacy and safety of C-Qur™ Film to decrease the incidence of adhesions after colorectal surgery.

Methods/design: This is a prospective, investigator initiated, randomized, double-blinded, multicenter trial. Eligible patients 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). Patients will return 8 to 16 weeks post-colorectal resection for take down of their ostomy. During ostomy takedown, adhesions will be evaluated for incidence, extent, and severity. The primary outcome evaluation will be assessment of adhesions to the incision site. It is hypothesized that the use of C-Qur™ Film underneath the primary incision reduces the incidence of adhesion at the incision by 30%. To demonstrate 30% reduction in the incidence of adhesions, a sample size of 84 patients (32 + 10 per group (25% drop out)) is required (two-sided test, α = 0.05, 80% power).

Discussion: Results of this study add to the evidence on the use of anti-adhesive barriers in open and laparoscopic 'hand-assisted' colorectal surgery. We chose incidence of adhesions to the incision site as primary outcome measure since clinical outcomes such as small bowel obstruction, secondary infertility and adhesiolysis related complications are considered multifactorial and difficult to interpret. Incidence of adhesions at repeat surgery is believed to be the most valuable surrogate endpoint for clinically relevant adhesion prevention, since small bowel obstruction and adhesiolysis at repeat surgery are not likely to occur when complete adhesion reduction in a patient is accomplished.

Trial registration: ClinicalTrials.gov Identifier NCT01872650, registration date 6 June 2013.

Show MeSH
Related in: MedlinePlus