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NCT02737553 · ADVERSE EVENTS

Adverse events

Laparoscopic Enclosed Morcellation; Electromechanic Morcellation vs Vaginal Removal · Source last updated 2022-01-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
3 months
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Enclosed Morcellation

In this group, 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.

0 / 490 / 490 / 49
Vaginal Morcellation

In this group, after extirpation of myoma from uterus and repair of the uterine defect, myoma will be removed through the vagina with posterior colpotomy.

0 / 480 / 480 / 48

Group identifiers: EG000: Enclosed Morcellation · EG001: Vaginal Morcellation

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        49
        description
        In this group, 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.
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        49
        serious Num Affected
        0
        serious Num At Risk
        49
        title
        Enclosed Morcellation
      2. deaths Num Affected
        0
        deaths Num At Risk
        48
        description
        In this group, after extirpation of myoma from uterus and repair of the uterine defect, myoma will be removed through the vagina with posterior colpotomy.
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        48
        serious Num Affected
        0
        serious Num At Risk
        48
        title
        Vaginal Morcellation
      frequency Threshold
      0
      time Frame
      3 months

      Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

      Preserved source evidence · Not medical advice