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NCT02737553 · OUTCOME

Postoperative Pain

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.

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
2 day

What was measured

Postoperative pain was compared between two groups using visual analog score in 0 to 10 scale. Participants were assessed in terms of pain with the Visual Pain Scale (VAS). The participants were asked to rate current pain on a 10-cm visual analog scale (VAS), with 0 being no pain and 10 the worst pain imaginable 48 hours after operation.

Groups in this outcome

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.

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Enclosed Morcellation49
Vaginal Morcellation48

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Enclosed Morcellation1.71.6Not reportedNot reportedNot reported
Vaginal Morcellation1.61.38Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.6
        value
        1.7
      2. group Id
        OG001
        spread
        1.38
        value
        1.6
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    2. group Id
      OG001
      value
      48
    units
    Participants
description
Postoperative pain was compared between two groups using visual analog score in 0 to 10 scale. Participants were assessed in terms of pain with the Visual Pain Scale (VAS). The participants were asked to rate current pain on a 10-cm visual analog scale (VAS), with 0 being no pain and 10 the worst pain imaginable 48 hours after operation.
dispersion Type
Standard Deviation
groups
  1. 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.
    id
    OG000
    title
    Enclosed Morcellation
  2. 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
    OG001
    title
    Vaginal Morcellation
param Type
MEAN
reporting Status
POSTED
time Frame
2 day
title
Postoperative Pain
type
OTHER_PRE_SPECIFIED
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice