Prevention of de-novo adhesion formation after laparoscopic myomectomy: a randomized trial to evaluate the effectiveness of an oxidized regenerated cellulose absorbable barrier. Expanded polytetrafluoroethylene (Gore-Tex Surgical Membrane) is superior to oxidized regenerated cellulose (Interceed TC7+) in preventing adhesions. Use of Interceed(TC7) absorbable adhesion barrier to reduce postoperative adhesion reformation in infertility and endometriosis surgery. The Obstetrics and Gynecology Adhesion Prevention Committee. Post-operative adhesions after laparoscopic electrosurgical treatment for polycystic ovarian syndrome with the application of Interceed to one ovary: a prospective randomized controlled study. Reduction of postoperative adhesion formation after laparoscopic ovarian cystectomy. Adhesion formation after laparoscopic ovarian cautery for polycystic ovarian syndrome: lack of correlation with pregnancy rate. Adhesion-prevention effects of fibrin sealants after laparoscopic myomectomy as determined by second-look laparoscopy: a prospective, randomized, controlled study. Reduction of adhesion reformation after laparoscopic endometriosis surgery: a randomized trial with an oxidized regenerated cellulose absorbable barrier.
To evaluate the effectiveness of the oxidized regenerated cellulose absorbable barrier (Interceed, TC7) in the prevention of de-novo adhesion formation after laparoscopic myomectomy, a prospective and randomized study was performed at the Department of Obstetrics and Gynaecology of the University of Cagliari, Cagliari, Italy. A total of 50 pre-menopausal non-pregnant women, aged 23-42 years, who submitted to laparoscopic myomectomy from January 1993 to June 1994, were randomized to surgery alone (control group, n = 25) or surgery and oxidized regenerated cellulose barrier (Interceed group, n = 25). Neither group received any other treatment for adhesion prevention. A second-look laparoscopy was performed 12-14 weeks after laparoscopic myomectomy. The incidence of adhesion-free patients was assessed at second-look laparoscopy by an investigator not informed of the treatment. The numbers of adhesion-free patients were three out of 25 (12%) in the control group and 15 out of 25 (60%) in the treatment group (P < 0.05). In conclusion, the oxidized regenerated cellulose absorbable barrier significantly reduced de-novo adhesion formation after laparoscopic myomectomy. To compare the impact of expanded polytetrafluoroethylene (PTFE; Gore-Tex Surgical Membrane; W. L. Gore & Associates, Inc., Flagstaff, AZ) and oxidized regenerated cellulose (Interceed TC7, Johnson & Johnson Medical, Inc., Arlington, TX) on the development of postsurgical adhesions.
                A multicenter, nonblinded, randomized clinical trial.
                University medical centers.
                Each barrier was allocated randomly to the left or right sidewall of every patient.
                Thirty-two women with bilateral pelvic sidewall adhesions undergoing reconstructive surgery and second-look laparoscopy.
                Adhesion score (on a 0- to 11-point scale), the area of adhesion (cm2), and the likelihood of no adhesions.
                The use of both barriers was associated with a lower adhesion score and area of adhesion postoperatively. However, those sidewalls covered with PTFE had a significantly lower adhesion score (0.97 +/- 0.30 versus 4.76 +/- 0.61 points, mean +/- SEM) and area of adhesion (0.95 +/- 0.35 versus 3.25 +/- 0.62 cm2). Overall, more sidewalls covered with PTFE had no adhesions (21 versus 7) and, when adhesions were present on the contralateral sidewall, the number of sidewalls covered with PTFE without adhesions was greater than those covered with oxidized regenerated cellulose (16 versus 2).
                Expanded polytetrafluoroethylene was associated with fewer postsurgical adhesions to the pelvic sidewall than oxidized regenerated cellulose. Interceed(TC7) is a fabric composed of oxidized, regenerated cellulose that was designed to reduce the formation of postsurgical adhesions. We evaluated Interceed(TC7) in a randomized, multicenter clinical study. Sixty-three infertility patients had bilateral pelvic sidewall adhesions removed at laparotomy. One pelvic sidewall was covered by Interceed(TC7) and the other was left uncovered. The deperitonealized areas (N = 205) of all sidewalls were divided into three groups: less than 100 mm2, N = 72; 100-1000 mm2, N = 95; and more than 1000 mm2, N = 38. The effectiveness of Interceed(TC7) was evaluated at laparoscopy 10-98 days after laparotomy. Significantly more adhesions were observed at laparoscopy on the control pelvic sidewalls (48 of 63, 76%) than on the treated sides (26 of 63, 41%) (P less than .0001). The Interceed(TC7)-treated sidewalls also had significantly less area involved with adhesions at laparoscopy (P less than .05, P less than .001, and P less than .001 in the three groups, respectively). Twenty-eight women with severe endometriosis also had significantly more adhesions on the control side (23 of 28, 82%) than on the treated side (14 of 28, 50%) (P less than .05). We conclude that Interceed(TC7) effectively reduced the incidence and extent of postoperative adhesions, even in patients with severe endometriosis. In this prospective, randomized, controlled clinical study, 21 women underwent a second-look laparoscopy 2-11 weeks after standardized laparoscopic electrosurgical treatment for polycystic ovarian syndrome (PCOS). Following bilateral ovarian treatment, one ovary was randomly chosen to have Interceed applied to its surface using a specially designed applicator, with the other ovary serving as a control. Peri-adnexal adhesions of significant extent and severity developed in 57% of the women and 38% of the adnexa. The incidence of adhesions on the Interceed-treated side was 43%, while on the control side it was 33%. In addition, the extent and severity of the adhesions appeared to be similar on the Interceed-treated and control side. However, larger numbers would be required to determine statistically the effects of Interceed on de-novo adhesion formation after laparoscopic electrosurgical treatment of PCOS, as described here. The purpose of this randomized, open-label study was to assess the efficacy of the product Interceed absorbable adhesion barrier in the prevention of adhesion formation on the ovary after laparoscopic ovarian cystectomy. A total of 25 patients requiring laparoscopic bilateral ovarian cystectomy were enrolled into this study. After removal of ovarian cysts, peri-adnexal adhesions, and peritoneal irrigants, and the attainment of meticulous haemostasis, the random assignment of one ovary for wrapping with Interceed was revealed to the surgeon. The other ovary served as the untreated control. A follow-up laparoscopy was performed 8-30 weeks after the initial procedure in 17 patients. Significantly fewer adhesions formed at the Interceed treated ovaries compared with the control (untreated) ovaries (P < 0.05). In terms of adhesion-free outcome, 76% (13/17) of Interceed treated ovaries and 35% (6/17) of control ovaries were free of adhesions. A significant reduction was observed in the area of the sutured ovaries involved with adhesions when Interceed (6%) was used, compared with controls (20%). The reduction of adhesion formation was not related to the size of the cysts at the initial procedure. No adverse events were reported by any patient during the study. In conclusion, Interceed was found to be safe and effective in reducing the incidence of postoperative adhesion formation in patients undergoing laparoscopic ovarian cystectomy. To assess adhesion formation after laparoscopic ovarian cautery in women with polycystic ovarian syndrome (PCOS) and the efficacy of Interceed Adhesion Barrier (Ethicon, Summerville, NJ) in their prevention.
                Prospective, randomized, blinded, clinical study of laparoscopic ovarian cautery with application of Interceed to one ovary, followed by short interval second-look laparoscopy, scoring of adhesions, and clinical follow-up.
                Tertiary care clinic at a University teaching hospital.
                Eight infertile women with PCOS who failed to conceive with previous clomiphene citrate (CC) therapy.
                Periovarian adhesions of varying severity developed in all women after laparoscopic ovarian cautery. Interceed showed no protective effect. Despite this finding, all women initiated regular menses after laparoscopic ovarian cautery and seven of eight women spontaneously conceived eight singleton pregnancies without any further therapy.
                Laparoscopic ovarian cautery should be considered in infertile women with PCOS who fail to respond to CC therapy. These women must be counseled with respect to the possible complication of postoperative adhesion formation. To examine the adhesion prevention effects of 2 types of fibrin sealant after laparoscopic myomectomy (LM).
                A prospective, randomized study (Canadian Task Force I) was conducted at a University-affiliated hospital. A total of 91 patients showing a minimal myoma > 5 cm, excluding pedunculated myomas, underwent LM alone: 32 patients in the control group, 29 in the fibrin gel group and 30 patients in the fibrin sheet group. After LM, postoperative adhesions were evaluated by second-look laparoscopy. The frequency of postoperative adhesions was the main outcome.
                The frequency of postoperative adhesions of the uterus was significantly lower (p < 0.05) in the fibrin gel group, with 20/32 (62.5%) in the control group, 10/29 (34.5%) in the fibrin gel group and 20/30 (67.7%) in the fibrin sheet group. Although no significant differences were found in the incidence of de novo adnexal adhesions, the lowest rate was found in the fibrin gel group, with 4/32 patients (12.5%) in the control group, 2/29 patients (6.8%) in the fibrin gel group and 5/30 patients (16.7%) in the fibrin sheet group. No bilateral adnexal adhesions were observed in the 3 groups.
                After LM for myomas as large as > or = 5 cm, postoperative adhesions were observed in > or = 50% of patients. The use of fibrin gel after LM is recommended. To evaluate the effectiveness of an oxidized regenerated cellulose absorbable barrier (Interceed [TC7] Absorbable Adhesion Barrier) in the reduction of adhesion reformation after laparoscopic surgery for endometriosis.
                Thirty-two premenopausal nonpregnant women who had severe endometriosis and complete posterior cul-de-sac obliteration and were undergoing laparoscopic surgery were randomly assigned to either surgery alone or surgery and Interceed. None of the subjects received any other treatment for adhesion prevention. Second-look laparoscopy was performed 12-14 weeks after laparoscopic surgery by an investigator blinded to the treatment, and the incidence of adhesion-free subjects was assessed.
                Twelve of 16 (75%) women treated with the oxidized regenerated cellulose barrier were free of adhesions, compared with two of 16 (12.5%) controls, a statistically significant difference (P < .05).
                The oxidized regenerated cellulose absorbable barrier significantly reduces adhesion reformation after laparoscopic surgery for endometriosis.
The absorbable adhesion barrier Interceed reduces the incidence of adhesion formation following laparoscopy and laparotomy, but there are insufficient data to support its use to improve pregnancy rates. Gore-Tex may be superior to Interceed in preventing adhesion formation but its usefulness is limited by the need for suturing and later removal. There was no evidence of effectiveness of Seprafilm and Fibrin sheet in preventing adhesion formation.