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Two randomized controlled trials comparing the tubal ring and filshie clip for tubal sterilization.

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.

Links

  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Family Health International, Research Triangle Park, North Carolina 27513, USA. dsokal@fhi.org

    , ,

    Source

    Fertility and sterility 74:3 2000 Sep pg 525-33

    MeSH

    Adult
    Female
    Humans
    Laparoscopy
    Pregnancy
    Prospective Studies
    Sterilization, Tubal

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, U.S. Gov't, Non-P.H.S.

    Language

    eng

    PubMed ID

    10973650

    Citation

    TY - JOUR T1 - Two randomized controlled trials comparing the tubal ring and filshie clip for tubal sterilization. AU - Sokal,D, AU - Gates,D, AU - Amatya,R, AU - Dominik,R, PY - 2000/9/26/pubmed PY - 2000/10/14/medline PY - 2000/9/26/entrez SP - 525 EP - 33 JF - Fertility and sterility JO - Fertil. Steril. VL - 74 IS - 3 N2 - 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. SN - 0015-0282 UR - https://www.unboundmedicine.com/medline/citation/10973650/Two_randomized_controlled_trials_comparing_the_tubal_ring_and_filshie_clip_for_tubal_sterilization_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0015028200006968 ER -