Adithya Suresh, MD, Ziad T Awad, MD FACS. University of Florida College of Medicine- Jacksonville
Seprafilm® adhesion barrier is proven to prevent adhesion formation after open abdominal and pelvic operations. However, with laparoscopy, a major technical roadblock is the delivery of these sheets into the peritoneal cavity. To avoid this problem, Seprafilm® slurry may be used to deliver the anti-adhesive barrier into the peritoneal cavity. The aim of this study was to evaluate the safety results, including incidence of postoperative complications and death after laparoscopic placement of Seprafilm® slurry in patients who underwent laparoscopic colectomy.
Methods: 100 consecutive laparoscopic colectomies [(group1, n=50, no Seprafilm, 07/2007-06/2008); (group 2, n=50, with Seprafilm® slurry, 07/2008-05/2009)] performed by a single surgeon was analyzed. In group 2, at the end of the procedure, two procedure packs of Seprafilm® (each pack containing six 3x 6 inch sheets) was made into a slurry by dissolving it into 120 mL of warm saline. This solution was then delivered into the peritoneal cavity using a 16 Fr. catheter. Group characteristics were evaluated with regard to age, sex, body mass index (BMI), and ASA score. Six complications: abdominal or pelvic abscess, anastomotic leak, wound infection, subcutaneous abscess, re-admission and re-operation within the first 30 days after surgery were reviewed. The chi square test was used to detect frequency differences among the complications from what was expected. The Relative Risks with 95% confidence intervals were calculated to determine whether differences in complication rates between the groups were statistically significant. Mortality was examined qualitatively at the 30 day post-operative period as well. Statistical analysis was performed using SPSS version 18.
Results: Both groups were statistically similar with regard to age, sex, BMI, and ASA score. Differences between control and experimental groups were examined for abdominal or pelvic abscess (4% Vs 2%); anastomotic leak (4% in both groups); subcutaneous abscess (2% in both groups). The rate of wound infection was 8% in group 1 and none in group 2. The re-operative rate was (8% Vs 6%), and the readmission rate was (6% Vs 8%). The mortality rate was 2% in group 1 and 4% in group 2. Neither the chi square tests or relative risks for complications were statistically significant. All deaths were unrelated to intra-abdominal complications in either group.
Conclusion: Initial data regarding Seprafilm® slurry indicate no significant difference in complication rates between control and experimental groups. This is the first study that evaluated the safety of Seprafilm® slurry in patients undergoing laparoscopic colectomy. Further long term follow-up is needed to test its efficacy.
Program Number: S022