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Purpose of this randomized control study is to determine if the mode of electrothermal colpotomy incision affects (1) the degree of thermal injury at the time of laparoscopic hysterectomy or (2) the incidence of clinical surrogates of compromised vaginal cuff healing. Women already scheduled for TLH will be randomized to colpotomy incision with the V mode or standard cut/coag form of electrothermal energy.
Prevalence of vaginal cuff injury will be calculated, and cross tabulation tables will be used to examine the association fo dehiscence with proposed risk factors in the retrospective part of the study. In the randomized controlled trial, depth of thermal injury will be compared between the two groups, and a chi-square test will be used to test for a difference in clinical outcomes between the two groups. There is little risk associated with this study above the normal surgical risks; however, the V mode has not been previously been studied for its use in making a colpotomy incision. Loss of confidentiality is a risk of the study, but all samples will be de-identified and given a unique study number, and only individuals directly involved in the study will be given access to the study information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cut/Coag | Active Comparator |
| |
| V-mode | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cut-Coag | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy | distance in millimeters over which thermal tissue injury extends (henceforth referred to as "injury"). | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | 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 | 4 weeks, 3 months, and 6 months after hysterectomy for a post-operative check and pelvic examination |
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Inclusion Criteria:
Exclusion Criteria:
1. Known pelvic infection within 30 days prior to hysterectomy
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| Name | Affiliation | Role |
|---|---|---|
| Paula S Lee, MD | Duke University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25305572 | Derived | Teoh D, Lowery WJ, Jiang X, Ehrisman J, Halvorson P, Broadwater G, Bentley R, Secord AA, Sobolewski C, Berchuck A, Havrilesky LJ, Valea FA, Lee PS. Vaginal cuff thermal injury by mode of colpotomy at total laparoscopic hysterectomy: a randomized clinical trial. J Minim Invasive Gynecol. 2015 Feb;22(2):227-33. doi: 10.1016/j.jmig.2014.10.002. Epub 2014 Oct 8. |
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19 subjects either withdrew or were excluded from the study. Thermal injury could not be assessed in 18 specimens because of sampling error.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy | distance in millimeters over which thermal tissue injury extends (henceforth referred to as "injury"). | 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. | Posted | Mean | Full Range | mm | up to 36 months | Vaginal Cuff Specimens | Participants |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Paula S Lee | Duke University Medical Center | 919-684-3765 | paula.s.lee@duke.edu |
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|
| V-mode | Procedure | 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 | Device | Use of surgical device Valleylab G3000 Electrosurgical Device |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Median | Full Range | kg/m^2 |
|
| OG001 | 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 |
|
|
| Secondary | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | 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 | This secondary objective was not evaluated | Posted | Number | 95% Confidence Interval | participants | 4 weeks, 3 months, and 6 months after hysterectomy for a post-operative check and pelvic examination |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | 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 | 0 | 52 | 0 | 52 |
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| Granulation Tissue 6 months post-op |
|
| Vaginal cuff induration 4 weeks post-op |
|
| Vaginal cuff induration 3 months post-op |
|
| Vaginal cuff induration 6 months post-op |
|
| Vaginal cuff infection 4 weeks post-op |
|
| Vaginal cuff infection 3 months post-op |
|
| Vaginal cuff infection 6 months post-op |
|