Laparoscopic Enclosed Morcellation; Electromechanic Morcellation vs Vaginal Removal
Condition: Myoma
Study type: Interventional

Summary: 
      Laparoscopic tissue removal is one of the most challenging parts for the laparoscopic
      surgery. For this reason, electromechanical morcellation has long been used to facilitate the
      tissue removal in gynecology. However, electromechanical morcellation has long been performed
      inside the abdomen without any containment. Therefore, this practice has recently undergone
      increased scrutiny because of important concerns related to tissue dissemination during
      intracorporeal power morcellation. Thus, the US Food and Drug Administration released a
      safety communication discouraging power morcellation in laparoscopic hysterectomy and
      myomectomy procedures in April 2014.

      As a result of this serious concern, the enclosed laparoscopic power morcellation has been
      come into prominence in gynecological surgery. Besides the removal of the tissues through
      vagina with posterior colpotomy is considered an another solution for this critical problem.

      In the literature the comparison for the two techniques for tissue removal is considerably
      scarce. Therefore researchers are aiming to prepare a trial to compare the laparoscopic
      enclosed electromechanical morcellation and tissue removal thorough vagina with posterior
      colpotomy according to surgical time, postoperative pain and postoperative sexual function.
    

Detailed description: 
      In this study researchers aiming to compare the compare the laparoscopic enclosed
      electromechanical morcellation and tissue removal thorough vagina with posterior colpotomy
      according to surgical time, postoperative pain and postoperative sexual function.

      Patients with an indication of myomectomy, between 18 to 40 years old, without prior
      abdominal surgery and without suspicious of malignancy will include into the study.
      Anticipated number of the patients will be 60. Participants will be randomized into two
      groups; group 1 enclosed electromechanical morcellation will be performed to remove the myoma
      out of the abdominal cavity; group 2 myoma will be removed through vagina with posterior
      colpotomy. In group 1, after extirpation of the myoma from the uterus and repair of the
      uterine defect, the myoma will be removed from the abdomen with an enclosed laparoscopic
      electromechanical morcellation with using surgical glove. In group 2, after extirpation of
      myoma from uterus and repair of the uterine defect, myoma will be removed through the vagina
      with posterior colpotomy. In this group myoma will also be removed in a enclosed fashion with
      using endo bag. Tissue removal time (for group 1 removal time is decided time between the
      insertion and removal of the morcellation, for group two removal time is decided time between
      start of the posterior colpotomy and end of the closure of the posterior colpotomy),
      postoperative time and sexual function of the patient and any of the complications will be
      compared. Visual pain score and female sexual function index questionnaire will be used to
      assess the postoperative pain and sexual function, respectively.
    

Intervention name(s): Enclosed morcellation; vaginal morcellation
Intervention type(s): Procedure; Procedure
Intervention description(s): After extirpation of the myoma from the uterus and repair of the uterine defect, the myoma will be removed from the abdomen with an enclosed laparoscopic electromechanical morcellation as described in the literature by Akdemir et al with using surgical glove (Akdemir A et. al, Innovative technique for enclosed morcellation using a surgical glove. Obstet Gynecol. 2015 May;125(5):1145-9. doi: 10.1097/AOG.0000000000000823.).; After extirpation of myoma from uterus and repair of the uterine defect, myoma will be removed through the vagina with posterior colpotomy. In this group myoma will also be removed in a enclosed fashion with using endo bag.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care