Two randomized controlled trials comparing the Tubal Ring and Filshie Clipfor tubal sterilization

Objective: To compare the effectiveness and safety of the Filshie Clip and Tubal Ring systems when applied via minilaparotomy and laparoscopy. Design: Prospective, multicenter randomized controlled clinical trial, with postoperative evaluation by a physician who was masked to the operative te chnique. Setting: Healthy volunteers in a variety of hospital settings. Patient(s): 2746 women (915 in the minilaparotomy study and 1831 in the lap aroscopy study) who had requested permanent surgical sterilization. Intervention(s): Surgical tubal ligation, using either Filshie Clips or Tub al Rings. A physician other than the surgeon evaluated the patients after t he operation and again at 1, 6, and 12 months after surgery. Main Outcome Measure(s): Pregnancy rates and safety-related events. Result(s): During the 12 months after surgery, two women who received the F ilshie Clip and two women who received the Tubal Ring became pregnant, givi ng a 12-month life-table pregnancy probability of 1.7 per 1000 women in bot h groups. The Tubal Ring was more difficult to apply and had higher rates o f tubal or mesosalpingeal injuries at surgery. The Filshie Clip group had t hree cases of spontaneous clip expulsion during the follow-up period. Conclusion(s): Both the Filshie Clip and Tubal Ring are effective and safe for use in tubal occlusion. (Fertil Steril(R) 2000;74:525-33. (C) 2000 by A merican Society for Reproductive Medicine.).