orabase and Uterine-Neoplasms

To assess the safety and efficacy of Sepraspray Adhesion Barrier (a modified hyaluronic acid and carboxymethylcellulose powder) after laparoscopic surgery, in view of both the high efficacy of Seprafilm Adhesion Barrier in reducing postoperative adhesions after open surgical procedures and the difficulty with laparoscopic delivery.. Multicenter, randomized, reviewer-blinded trial.. Reproductive endocrinology and infertility clinics.. Women undergoing laparoscopic myomectomy for indications including infertility.. Randomization to treatment with (n = 21) or without (n = 20) Sepraspray Adhesion Barrier.. Postoperative adhesions development was assessed at early second-look laparoscopy. Adhesions were scored using the modified American Fertility Society scoring system.. Surgical procedure duration length was 99 versus 102 minutes in the control versus Sepraspray Adhesion Barrier groups, respectively, with the median number of fibroids removed being two in each group and corresponding fibroid weights of 134 ± 103 versus 113 ± 161 g, respectively. Adhesions scores increased in both the control and Sepraspray Adhesion Barrier groups, with larger although nonstatistically significant increases noted in control subjects when evaluating for the anterior uterus, the posterior uterus, and the entire uterus.. Laparoscopic application of Sepraspray Adhesion Barrier after myomectomy in this pilot study was associated with a trend toward a reduction in postoperative adhesion development, as well as an encouraging safety profile. Further evaluation is warranted.. Sepraspray Adhesion Barrier #NCT00624930.

Topics: Adult; Carboxymethylcellulose Sodium; Female; Gynecologic Surgical Procedures; Humans; Hyaluronic Acid; Laparoscopy; Leiomyoma; Pilot Projects; Postoperative Complications; Powders; Prospective Studies; Second-Look Surgery; Time Factors; Tissue Adhesions; Treatment Outcome; United States; Uterine Neoplasms

A prior analysis of patients undergoing laparotomy for ovarian malignancies at our institution revealed an increased rate of intra-abdominal collections using HA-CMC film during debulking surgery. The primary objective of the current study was to determine whether the use of HA-CMC is associated with the development of postoperative intra-abdominal collections in patients undergoing laparotomy for uterine or cervical malignancies.. We retrospectively identified all laparotomies performed for these malignancies from 3/1/05 to 12/31/07. We identified cases involving the use of HA-CMC via billing records and operative reports. Intra-abdominal collections were defined as localized intraperitoneal fluid accumulations in the absence of re-accumulating ascites. We noted incidences of intra-abdominal collections, as well as other complications. Appropriate statistical tests were applied using SPSS 15.0.. We identified 169 laparotomies in which HA-CMC was used and 347 in which HA-CMC was not used. The following were statistically similar in both cohorts: age, body mass index (BMI), primary site, surgery for recurrent disease, prior intraperitoneal surgery, and extent of current surgery. Intra-abdominal collections were seen in 6 (3.6%) of 169 HA-CMC cases compared to 10 (2.9%) of 347 non-HA-CMC cases (p=0.7). The rate of infected collections was similar in both groups (1.2% vs. 1.4%). In the subgroup that underwent tumor debulking, intra-abdominal collections were seen in 3 (11.5%) of 26 HA-CMC cases compared to 2 (5.4%) of 37 non-HA-CMC cases (p=0.6).. HA-CMC use does not appear to be associated with postoperative intra-abdominal collections in patients undergoing laparotomy for uterine or cervical cancer.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Carboxymethylcellulose Sodium; Female; Humans; Hyaluronic Acid; Laparotomy; Middle Aged; Retrospective Studies; Uterine Cervical Neoplasms; Uterine Neoplasms; Young Adult