Randomized Controlled Trial (RCT)Comparing GYNAECARE MORCELLEX Versus ROTOCUT GI Tissue Morcellators
Condition: Uterine Myomas
MeSH terms: Myoma; Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 4

Summary: 
      To date, laparoscopic approach may apply to several gynecologic diseases. Among the recent
      advances in laparoscopy an important role was assumed by the methods of tissue extraction. In
      particular electronic power morcellators have become instruments of large use in surgical
      practice.

      The tissue morcellator is an endoscopic instrument indicated for cutting, coring and
      extracting tissue in operative laparoscopy, and it has a pivotal role during specific
      gynaecologic procedures as well as myomectomy and hysterectomy. The main advantages offered
      by electronic morcellator consist in reduction of operative time and of risk in hernia
      formation, this last due to the absence of fascia's tearing or stretching.

      Recently, a new generation of tissue morcellator has been commercialized. In particular,
      GYNECARE MORCELLEX (Ethicon-Johnson & Johnson Gateway, US) and ROTOCUT G1 (Karl Storz, Culver
      City, CA, US) are two tissue morcellators currently available. These instruments seem to
      offer advantages over the previous models in terms of precision, speed and durability. The
      most useful of this features seems to be the higher speed, in particular it has been
      calculated that they morcellate tissues approximately four times faster than those of the
      previous generation. The high speed that characterizes this new morcellator potentially
      results in reduced operative time with consequent benefits in other surgical outcomes such as
      postoperative pain and recovery time.

      Even if both morcellator seems to be high-quality instruments, no study was designed until
      now to compare these two tools in a prospective fashion.
    

Detailed description: 
      Patients with symptomatic uterine leiomyomas will be assessed for eligibility and will be
      enrolled in the present protocol-study.

      At entry, in each woman age, parity, body mass index (BMI), menopausal, socioeconomic and
      work status, symptoms related to the gynecologic disease, previous major surgical
      laparotomies, and associated medical condition will be assessed.

      All eligible patients will be randomized in single blocks using a central computer generating
      randomization lists (University of Catanzaro). The subjects will be assigned to one of four
      subgroups of surgical treatment, i.e. group A1 myomectomies performed using GYNECARE
      MORCELLEX, group A2 supracervical hysterectomies performed using GYNECARE MORCELLEX, group B1
      myomectomies performed using ROTOCUT G1 and group B2 supracervical hysterectomies performed
      using ROTOCUT G1.

      Before surgery, for each patient gynaecological and rectal examination, Papanicolau smear
      test, ultrasonographic and hysteroscopic assessment with endometrial biopsy will be
      performed.

      For each surgical intervention the following parameters will be recorded: duration of
      surgical procedures, intra-operative blood loss, amount of blood transfusion, intra-operative
      complications, number of laparotomic conversion, postoperative pain, post-operative
      complications, hospital stay, and time to return to full activity and/or work.

      Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less
      will be considered significant.
    

Intervention name(s): Laparoscopic myomectomy and supracervical hysterectomy with GYNECARE MORCELLEX; Laparoscopic myomectomy and supracervical hysterectomy with ROTOCUT G1
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic myomectomy with GYNECARE MORCELLEX: Laparoscopic approach. Longitudinal incision close to the midline of myoma. Identification of cleavage plane. Enucleation of myoma. Suturing myometrial. Removal of myoma with a automatic morcellator (GYNECARE MORCELLEX).
Laparoscopic supracervical hysterectomy using GYNECARE MORCELLEX: Laparoscopic approach. Use of bipolar diathermy and scissor starting with the round ligament and then the utero-ovarian ligament, otherwise the infundibulopelvic ligament in case of removal of adnexa. Identification, desiccation with polar diathermy, and transection of the uterine vessels. Repetition of the procedure on the contra-lateral side. Opening of vagina just below uterine vessels using an unipolar needle. Removal of uterus by means of GYNECARE MORCELLEX. Abdominal cavity irrigation.; Laparoscopic myomectomy with ROTOCUT G1: Laparoscopic approach. Longitudinal incision close to the midline of myoma. Identification of cleavage plane. Enucleation of myoma. Suturing myometrial. Removal of myoma with a automatic morcellator (ROTOCUT G1).
Laparoscopic supracervical hysterectomy using ROTOCUT G1: Laparoscopic approach. Use of bipolar diathermy and scissor starting with the round ligament and then the utero-ovarian ligament, otherwise the infundibulopelvic ligament in case of removal of adnexa. Identification, desiccation with polar diathermy, and transection of the uterine vessels. Repetition of the procedure on the contra-lateral side. Opening of vagina just below uterine vessels using an unipolar needle. Removal of uterus by means of ROTOCUT G1. Abdominal cavity irrigation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: laparoscopy; myomectomy; myomas; morcellator; supracervical hysterectomy; surgery; symptomatic uterine myomas