Trial Outcomes & Findings for Vaginal Cuff Dehiscence and Thermal Injury During TLH (NCT NCT02080546)
NCT ID: NCT02080546
Last Updated: 2016-06-03
Results Overview
distance in millimeters over which thermal tissue injury extends (henceforth referred to as "injury").
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
up to 36 months
Results posted on
2016-06-03
Participant Flow
19 subjects either withdrew or were excluded from the study. Thermal injury could not be assessed in 18 specimens because of sampling error.
Participant milestones
| Measure |
Cut/Coag
Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the "cut" (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the "coag" (pulsed high-voltage, low-current) mode.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device
|
V-mode
V-mode: Incision using electrothermal cautery in the "V mode". The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
63
|
|
Overall Study
COMPLETED
|
49
|
52
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaginal Cuff Dehiscence and Thermal Injury During TLH
Baseline characteristics by cohort
| Measure |
Cut/Coag
n=49 Participants
Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the "cut" (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the "coag" (pulsed high-voltage, low-current) mode.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device
|
V-mode
n=52 Participants
V-mode: Incision using electrothermal cautery in the "V mode". The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
54 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
52 participants
n=7 Participants
|
101 participants
n=5 Participants
|
|
Body Mass Index
|
33 kg/m^2
n=5 Participants
|
32 kg/m^2
n=7 Participants
|
32.5 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 36 monthsPopulation: 49 participants were included in the cut/coag arm and 52 participants in the V mode arm. Thermal injury was assessed at the anterior margin in 91 specimens and at the posterior margin in 93 specimens.
distance in millimeters over which thermal tissue injury extends (henceforth referred to as "injury").
Outcome measures
| Measure |
Cut/Coag
n=87 Vaginal Cuff Specimens
Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the "cut" (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the "coag" (pulsed high-voltage, low-current) mode.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device
|
V-mode
n=97 Vaginal Cuff Specimens
V-mode: Incision using electrothermal cautery in the "V mode". The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device
|
|---|---|---|
|
Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy
Anterior Depth of thermal injury (mm)
|
0.68 mm
Interval 0.18 to 1.43
|
0.63 mm
Interval 0.3 to 1.4
|
|
Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy
Posterior Depth of thermal injury (mm)
|
0.66 mm
Interval 0.15 to 1.55
|
0.70 mm
Interval 0.2 to 1.63
|
SECONDARY outcome
Timeframe: 4 weeks, 3 months, and 6 months after hysterectomy for a post-operative check and pelvic examinationPopulation: This secondary objective was not evaluated
a difference between arms in the proportion of patients who have at least one of the following post-operatively: vaginal vault granulation tissue, vaginal cuff separation/dehiscence, or vaginal apex infection
Outcome measures
| Measure |
Cut/Coag
n=49 Participants
Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the "cut" (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the "coag" (pulsed high-voltage, low-current) mode.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device
|
V-mode
n=52 Participants
V-mode: Incision using electrothermal cautery in the "V mode". The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.
Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device
|
|---|---|---|
|
Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing
Granulation Tissue 4 weeks post-op
|
6 participants
Interval 1.0 to 11.0
|
8 participants
Interval 2.0 to 20.0
|
|
Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing
Granulation Tissue 3 months post-op
|
18 participants
Interval 8.0 to 34.0
|
21 participants
Interval 9.0 to 36.0
|
|
Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing
Granulation Tissue 6 months post-op
|
10 participants
Interval 2.0 to 27.0
|
11 participants
Interval 2.0 to 28.0
|
|
Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing
Vaginal cuff induration 4 weeks post-op
|
2 participants
Interval 0.0 to 11.0
|
4 participants
Interval 0.0 to 14.0
|
|
Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing
Vaginal cuff induration 3 months post-op
|
0 participants
Interval 0.0 to 0.0
|
5 participants
Interval 1.0 to 17.0
|
|
Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing
Vaginal cuff induration 6 months post-op
|
0 participants
Interval 0.0 to 0.0
|
0 participants
Interval 0.0 to 0.0
|
|
Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing
Vaginal cuff infection 4 weeks post-op
|
4 participants
Interval 0.0 to 14.0
|
0 participants
Interval 0.0 to 0.0
|
|
Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing
Vaginal cuff infection 3 months post-op
|
0 participants
Interval 0.0 to 0.0
|
10 participants
Interval 3.0 to 24.0
|
|
Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing
Vaginal cuff infection 6 months post-op
|
0 participants
Interval 0.0 to 0.0
|
0 participants
Interval 0.0 to 0.0
|
Adverse Events
Cut/Coag
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
V-mode
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place