Selected article for: "clinical study and safety clinical study"

Author: Ardovino, Mario; Castaldi, Maria Antonietta; Fraternali, Fernando; Ardovino, Italo; Mosca, Lavinia; Colacurci, Nicola; Signoriello, Giuseppe; Cobellis, Luigi
Title: Bidirectional barbed suture in total laparoscopic hysterectomy and lymph node dissection for endometrial cancer: technical evaluation and 1-year follow-up of 61 patients.
  • Cord-id: zoadq4iy
  • Document date: 2013_1_1
  • ID: zoadq4iy
    Snippet: OBJECTIVE This randomized clinical study compared the feasibility and safety of the shortest suture for bidirectional knotless barbed versus standard sutures, with either extracorporeal or intracorporeal knots, for vaginal cuff closure following total laparoscopic hysterectomy (TLH) and lymph node dissection for early endometrial cancer. SUBJECTS AND METHODS The study design was Canadian Task Force Classification I. In tertiary-care university-based teaching hospitals, 61 women underwent TLH and
    Document: OBJECTIVE This randomized clinical study compared the feasibility and safety of the shortest suture for bidirectional knotless barbed versus standard sutures, with either extracorporeal or intracorporeal knots, for vaginal cuff closure following total laparoscopic hysterectomy (TLH) and lymph node dissection for early endometrial cancer. SUBJECTS AND METHODS The study design was Canadian Task Force Classification I. In tertiary-care university-based teaching hospitals, 61 women underwent TLH and lymph node dissection. In accord with randomization, the vaginal cuff in TLH was closed with either extracorporeal or intracorporeal knots (1-Monocryl(®); Ethicon Inc., Somerville, NJ) and a bidirectional knotless barbed suture (0-Quill™; Angiotech Pharmaceuticals, Inc., Vancouver, BC, Canada). All patients were evaluated at 3-month, 6-month, and 1-year follow-up. RESULTS Time required to suture was significantly lower in the group treated with bidirectional suture than in groups with traditional sutures (P<.001). No significant difference was observed in the operative time between the study groups. The degree of surgical difficulty was significantly lower in the bidirectional barbed suture group than in the other groups. At 1-year follow-up all patients presented no wound dehiscence, no bleeding, dyspareunia, and other potential major complications such as ureteric, bladder, or bowel injury. CONCLUSIONS Use of a barbed suture reduces the time required to repair the vaginal cuff during TLH. At follow-up of patients, carried out 3 months, 6 months, and 1 year after the surgery, no wound dehiscence, no bleeding, or no other potential major surgical complications had occurred.

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