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NCT02737553 · OUTCOME

Sexual Functional Assessment

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
3 months

What was measured

Sexual function will be assessed with using "Female Sexual Function Index questionnaire" and it will be compared between two groups. Participants were requested to fill FSFI (Female Sexual Function Index) forms to evaluate their sexual lives. The FSFI consists of 19 questions and is a validated questionnaire for the assessment of sexual function. The questions are grouped into the subdomains of libido, arousal, lubrication, orgasm, satisfaction, and pain. The total score is determined by summing up the subdomains scores. Higher scores reflect better sexual function; maximum score is 36 and minimum score is 0. For each subdomain, higher scores reflect better sexual function; maximum score is 6 and minimum score is 0 including pain, in which 0 reflects lots of pain and 6 reflects the absence of pain.

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 by Akdemir et al with using surgical glove.

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 Morcellation18.49.9Not reportedNot reportedNot reported
Vaginal Morcellation25.34.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.9
        value
        18.4
      2. group Id
        OG001
        spread
        4.3
        value
        25.3
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    2. group Id
      OG001
      value
      48
    units
    Participants
description
Sexual function will be assessed with using "Female Sexual Function Index questionnaire" and it will be compared between two groups. Participants were requested to fill FSFI (Female Sexual Function Index) forms to evaluate their sexual lives. The FSFI consists of 19 questions and is a validated questionnaire for the assessment of sexual function. The questions are grouped into the subdomains of libido, arousal, lubrication, orgasm, satisfaction, and pain. The total score is determined by summing up the subdomains scores. Higher scores reflect better sexual function; maximum score is 36 and minimum score is 0. For each subdomain, higher scores reflect better sexual function; maximum score is 6 and minimum score is 0 including pain, in which 0 reflects lots of pain and 6 reflects the absence of pain.
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 by Akdemir et al with using surgical glove.
    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
3 months
title
Sexual Functional Assessment
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