NCT02737553 · STUDY IN CONTEXT

Laparoscopic Enclosed Morcellation; Electromechanic Morcellation vs Vaginal Removal

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

exploratory · POSTED

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.

Source null

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exploratory · POSTED

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.

Source null

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primary · POSTED

Total operation time will be compared between two groups in seconds.

Source null

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secondary · POSTED

After extirpation of the myoma in group 1 the fibroid was placed into the glove within the abdomen. The morcellation was accomplished within the completely enclosed glove. In Group 2, after extirpation of the myoma, it was removed through the vagina through posterior colpotomy. An endoscopic specimen bag was placed into the abdomen following the vaginal posterior colpotomy. Then, the fibroid was placed into the endoscopic bag within the abdomen. The specimen was removed with coring technique via scalpel. Posterior colpotomy incision was then sutured vaginally. Morcellation time is decided time between the insertion and removal of the surgical glove in group 1 and time between start of the posterior colpotomy and end of the closure of the posterior colpotomy in group 2. Tissue morcellation time compared between two groups in seconds.

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-myoma
nct id: NCT02737553
trial label: Laparoscopic Enclosed Morcellation; Electromechanic Morcellation vs Vaginal Removal
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-myoma
nct id
NCT02737553
outcome key
om-0002
source section id
NCT02737553-om-0002
source outcome index
2
endpoint
Postoperative Pain
endpoint definition
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.
time origin
2 day
analysis role
exploratory
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myoma
nct id
NCT02737553
outcome key
om-0003
source section id
NCT02737553-om-0003
source outcome index
3
endpoint
Sexual Functional Assessment
endpoint definition
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.
time origin
3 months
analysis role
exploratory
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myoma
nct id
NCT02737553
outcome key
om-0000
source section id
NCT02737553-om-0000
source outcome index
0
endpoint
Operation Time
endpoint definition
Total operation time will be compared between two groups in seconds.
time origin
1 day
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myoma
nct id
NCT02737553
outcome key
om-0001
source section id
NCT02737553-om-0001
source outcome index
1
endpoint
Morcellation Time
endpoint definition
After extirpation of the myoma in group 1 the fibroid was placed into the glove within the abdomen. The morcellation was accomplished within the completely enclosed glove. In Group 2, after extirpation of the myoma, it was removed through the vagina through posterior colpotomy. An endoscopic specimen bag was placed into the abdomen following the vaginal posterior colpotomy. Then, the fibroid was placed into the endoscopic bag within the abdomen. The specimen was removed with coring technique via scalpel. Posterior colpotomy incision was then sutured vaginally. Morcellation time is decided time between the insertion and removal of the surgical glove in group 1 and time between start of the posterior colpotomy and end of the closure of the posterior colpotomy in group 2. Tissue morcellation time compared between two groups in seconds.
time origin
1 day
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-myoma
nct id
NCT02737553
outcome key
om-0000
arm key
OG000
arm label
Enclosed Morcellation
regimen
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.
analyzed count
49
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02737553-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myoma
nct id
NCT02737553
outcome key
om-0000
arm key
OG001
arm label
Vaginal Morcellation
regimen
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.
analyzed count
48
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02737553-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myoma
nct id
NCT02737553
outcome key
om-0001
arm key
OG000
arm label
Enclosed Morcellation
regimen
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.
analyzed count
49
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02737553-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myoma
nct id
NCT02737553
outcome key
om-0001
arm key
OG001
arm label
Vaginal Morcellation
regimen
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.
analyzed count
48
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02737553-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myoma
nct id
NCT02737553
outcome key
om-0002
arm key
OG000
arm label
Enclosed Morcellation
regimen
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.
analyzed count
49
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02737553-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myoma
nct id
NCT02737553
outcome key
om-0002
arm key
OG001
arm label
Vaginal Morcellation
regimen
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.
analyzed count
48
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02737553-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myoma
nct id
NCT02737553
outcome key
om-0003
arm key
OG000
arm label
Enclosed Morcellation
regimen
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.
analyzed count
49
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02737553-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myoma
nct id
NCT02737553
outcome key
om-0003
arm key
OG001
arm label
Vaginal Morcellation
regimen
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.
analyzed count
48
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02737553-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-myoma
nct id
NCT02737553
harm key
EG000
source section id
NCT02737553-ae
event group key
EG000
event group label
Enclosed Morcellation
serious affected
0
serious at risk
49
other affected
0
other at risk
49
frequency threshold
0
collection period
3 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-myoma
nct id
NCT02737553
harm key
EG001
source section id
NCT02737553-ae
event group key
EG001
event group label
Vaginal Morcellation
serious affected
0
serious at risk
48
other affected
0
other at risk
48
frequency threshold
0
collection period
3 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice