Department of Obstetrics and Gynecology, University of Colorado Health Sciences Center, Denver, Colorado, USA
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Abstract |
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Key words: adhesions/expanded polytetrafluoroethylene/pelvis/reproductive surgery/surgical barriers
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Introduction |
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Despite its proven efficacy, use of the ePTFE membrane to prevent pelvic adhesions has not gained wide acceptance. The reasons for slow acceptance of this adhesion barrier are not clear, but may be due to concerns about ease of use or uncertainty about long-term safety. A multicentre study found that the ePTFE membrane was easy to use and increased surgical time by <11 min when staples were used to anchor the device during laparoscopic surgery (Crain et al., 1995). Long-term safety of the ePTFE membrane has been established in thoracic surgery and neurosurgery (Inoue et al., 1984; Jacobs et al., 1996
). However, no previous studies have confirmed long-term safety of the ePTFE membrane in pelvic surgery. Therefore the goal of this study was to determine whether permanent implantation of the membrane in the pelvis to prevent adhesions was associated with any adverse events.
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Materials and methods |
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The manufacturer's guidelines for use of ePTFE membrane were followed. Prophylactic antibiotic therapy was administered routinely. The membrane was placed to cover the defect and overlap the edges by 1 cm, when possible. The membrane was implanted to lie as flat as possible, and at least one permanent anchoring suture or staple was used. Additional permanent or absorbable sutures or staples were used at the discretion of the surgeon.
Postoperatively, patients were examined routinely. Clinical follow-up assessments included recording of any adverse event possibly related to implantation of the membrane, e.g. infection. Pregnancy outcome was recorded. In patients who underwent subsequent surgery, the membrane implantation site was evaluated for the presence of pelvic adhesions.
Standard forms were completed for each patient visit and surgical procedure and sent to a central registry for data analysis. In patients who underwent subsequent surgery, the difference between the presence of adhesions at the initial and the subsequent surgical procedure was compared with the 2 test. A P value
0.05 was considered significant.
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Results |
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Thirty-two patients became pregnant after their initial surgical procedure (Table II). Two ectopic pregnancies occurred in women in whom the membrane had been placed in the sidewall after adhesiolysis. Three women had first-trimester spontaneous abortions requiring dilatation and curettage; in each, the membrane had been implanted on the uterus. There were 12 vaginal deliveries, two by women with a uterine implantation site. There were 10 deliveries by Caesarean section, eight in women with uterine implantation sites. Four pregnancies are ongoing. The course of all pregnancies that have progressed beyond the first trimester was uneventful, including 10 women who had a uterine implantation site. One women with a cul-de-sac implantation site delivered a stillborn infant. The stillbirth was attributed to a nuchal cord, and there did not appear to be any relation to use of the ePTFE membrane. No complications were noted at the time of Caesarean section in the eight women in whom the ePTFE membrane was implanted on the uterus. There were no obstetric complications that could be attributed to the ePTFE membrane.
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Discussion |
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Assessment of the efficacy of the ePTFE membrane was not a goal of the study, since the effectiveness of this device in pelvic surgery was demonstrated clearly in earlier studies. In theory, the ePTFE membrane mechanically separates traumatized peritoneal surfaces, and allows each to heal without forming adhesions. Histological examination of the ePTFE membrane removed after second-look laparoscopy demonstrated no tissue attachment in a previous report (Haney et al., 1995). A preliminary clinical study found a dramatic reduction in adhesion reformation with use of the ePTFE membrane that was far superior to results obtained with other anti-adhesion agents (Surgical Membrane Study Group, 1992
). In a prospective, randomized clinical study, ePTFE membrane significantly reduced myomectomy site adhesions at the uterine fundus and posterior uterus in comparison with results achieved with microsurgery alone (Myomectomy Adhesion Multicenter Study Group, 1995). Another prospective, randomized clinical trial found that the ePTFE membrane was significantly more effective than oxidized regenerated cellulose for prevention of pelvic sidewall adhesions (Haney et al., 1995
).
Despite the strong evidence of its safety and efficacy, the ePTFE peritoneal membrane is underused in pelvic surgery. An estimated 8000 myomectomies are performed in the USA each year (Golan, 1996). Adhesions to the uterine fundus and posterior portion of the uterus may occur in over 90% of incision sites after myomectomy (Tulandi et al., 1993
; Myomectomy Adhesion Multicenter Group, 1995
; Diamond et al., 1996
). An absorbable membrane composed of sodium hyaluronate and carboxymethylcellulose (Seprafilm®; Genzyme Corporation, Cambridge, MA, USA) did not significantly decrease formation of posterior uterine adhesions after myomectomy, although adhesions to the anterior uterine surface were reduced (Diamond et al., 1996
). However, 65% of women in whom this absorbable membrane was implanted were later found to have adhesions between the posterior uterus and large bowel after myomectomy. In addition, in more than 90% of women adnexal adhesions may form after a posterior uterine myomectomy (Tulandi et al., 1993
). With respect to oxidized regenerated cellulose, serious concerns have been raised about its use in a site that is not completely haemostatic (Linsky et al., 1988
). Thus, its use in myomectomies is not advisable.
In contrast, despite the propensity of the uterine fundus and posterior uterus to form adhesions, more than 55% of myomectomy incisions at these sites were completely free of adhesions when the ePTFE membrane was used as an adhesion barrier (Myomectomy Adhesion Multicenter Group, 1995). Annual use of more than 10 000 ePTFE peritoneal membranes could be justified for this indication alone. However, this adhesion barrier is probably used far less often, and most surgeons who perform myomectomies probably do not use this device.
In conclusion, our large multicentre study confirmed the long-term safety of use of the ePTFE peritoneal membrane to reduce adhesions after pelvic reconstruction. No complications associated with the adhesion barrier were observed at any follow-up visits, and no obstetrical problems associated with the ePTFE membrane were identified, even in women in whom the device was implanted on the uterus. Furthermore, no membrane-related problems were observed in patients who had subsequent surgery, and a significant reduction in adhesion formation was found in this group. Our findings support the routine use of the ePTFE adhesion barrier in gynaecological reconstructive surgery. Second-look laparoscopy to remove the membrane is not necessary.
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Acknowledgments |
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Notes |
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1 To whom correspondence should be addressed at: Department of Obstetrics and Gynecology, University of Kentucky Medical Center, 800 Rose Street, Lexington, Kentucky 40536, USA
§ J.Crain, Women's Specialty Center, Charlotte, NC; D.Curole, Ochsner Clinic, New Orleans, LA; G.Hill, Nashville Fertility Center, Nashville, TN; D.A.Metzger, Reproductive Medical Institute of Connecticut, Hartford, CT; A.A.Murphy, Department of Obstetrics and Gynecology, Emory University School of Medicine, Atlanta, GA; M.Perloe, Atlanta Reproductive Health Center, Atlanta, GA; H.Reich, Wyoming Valley Health Care System, Wilkes-Barre, PA; G.Rowe, Baylor College of Medicine, Houston, TX; J.S.Sanfilippo, University of Louisville School of Medicine, Louisville, KY; W.D.Schlaff, Department of Obstetrics and Gynecology, University of Colorado, Denver, CO; S.Taylor, The Fertility Institute, New Orleans, LA; and R.Wing, Women's Specialty Center, Charlotte, NC, USA.
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References |
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Submitted on August 7, 1998; accepted on December 21, 1998.