D Sokal1, D Gates, R Amatya, R Dominik. 1. Family Health International, Research Triangle Park, North Carolina 27513, USA. dsokal@fhi.org
Abstract
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 technique. SETTING:Healthy volunteers in a variety of hospital settings. PATIENT(S): 2746 women (915 in the minilaparotomy study and 1831 in the laparoscopy study) who had requested permanent surgical sterilization. INTERVENTION(S): Surgical tubal ligation, using either Filshie Clips or Tubal Rings. A physician other than the surgeon evaluated the patients after the 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 Filshie Clip and two women who received the Tubal Ring became pregnant, giving a 12-month life-table pregnancy probability of 1.7 per 1000 women in both groups. The Tubal Ring was more difficult to apply and had higher rates of tubal or mesosalpingeal injuries at surgery. The Filshie Clip group had three 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.
RCT Entities:
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 technique. SETTING: Healthy volunteers in a variety of hospital settings. PATIENT(S): 2746 women (915 in the minilaparotomy study and 1831 in the laparoscopy study) who had requested permanent surgical sterilization. INTERVENTION(S): Surgical tubal ligation, using either Filshie Clips or Tubal Rings. A physician other than the surgeon evaluated the patients after the 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 Filshie Clip and two women who received the Tubal Ring became pregnant, giving a 12-month life-table pregnancy probability of 1.7 per 1000 women in both groups. The Tubal Ring was more difficult to apply and had higher rates of tubal or mesosalpingeal injuries at surgery. The Filshie Clip group had three 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.
Authors: Isabella Claure; Deborah Anderson; Catherine M Klapperich; Wendy Kuohung; Joyce Y Wong Journal: Ann Biomed Eng Date: 2019-11-07 Impact factor: 3.934