NCT02192606 · ADVERSE EVENTS

Adverse events

Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? · Source last updated 2018-01-24

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: Adverse event data was collected from the day of surgery to 8 weeks following the operation.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
2D Laparoscopy The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy 2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.	0 / 29	3 / 29	0 / 29
3D Laparoscopy The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy. Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.	0 / 28	4 / 28	0 / 28

Group identifiers: EG000: 2D Laparoscopy · EG001: 3D Laparoscopy

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.

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Subject presented to ER 5 days after discharge concerned about blood clot in hand where IV had been. Seen and prescribed warm compresses and discharged.
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
29
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
ER visit
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Subject presented to ER 18 days after surgery with abdominal pain. Rxed with dilaudid; required re-operation for cuff dehiscence.
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
0
num At Risk
29
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Reoperation for vaginal cuff dehiscence
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Subject experienced some postoperative red/itching around incision sites - near smaller incisions like a rash; advised oral antihistamines and topical hydrocortisone for presumed dermabond reaction. Improved with treatment.
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
29
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Iritation around abdominal surgical incision site
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Subject was treated with antibiotics for postoperative incision cellulitis.
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
29
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Incision cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Subjected was treated with diflucan for postoperative yeast infection.
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Yeast infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Intraoperative cystotomy (bladder injury), repaired laparoscopically. Normal recovery.
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Intraoperative complication
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Subject had postoperative urinary retention with transient Foley catheter needed but returned to normal by post-operative follow up.
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Urinary retention

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
29
description
The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy 2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
id
EG000
other Num Affected
3
other Num At Risk
29
serious Num Affected
0
serious Num At Risk
29
title
2D Laparoscopy
deaths Num Affected
0
deaths Num At Risk
28
description
The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy. Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
id
EG001
other Num Affected
4
other Num At Risk
28
serious Num Affected
0
serious Num At Risk
28
title
3D Laparoscopy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Subject presented to ER 5 days after discharge concerned about blood clot in hand where IV had been. Seen and prescribed warm compresses and discharged.
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
29
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
ER visit
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Subject presented to ER 18 days after surgery with abdominal pain. Rxed with dilaudid; required re-operation for cuff dehiscence.
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
0
num At Risk
29
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Reoperation for vaginal cuff dehiscence
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Subject experienced some postoperative red/itching around incision sites - near smaller incisions like a rash; advised oral antihistamines and topical hydrocortisone for presumed dermabond reaction. Improved with treatment.
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
29
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Iritation around abdominal surgical incision site
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Subject was treated with antibiotics for postoperative incision cellulitis.
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
29
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
Incision cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Subjected was treated with diflucan for postoperative yeast infection.
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Yeast infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Intraoperative cystotomy (bladder injury), repaired laparoscopically. Normal recovery.
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Intraoperative complication
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Subject had postoperative urinary retention with transient Foley catheter needed but returned to normal by post-operative follow up.
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
29
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
Urinary retention

time Frame

Adverse event data was collected from the day of surgery to 8 weeks following the operation.

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Preserved source evidence · Not medical advice