Thermal Injury, Vaginal Cuff Dehiscence
Conditions
Keywords
Vaginal cuff dehiscence, Thermal Injury, Total laparoscopic hysterectomy
Brief summary
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.
Interventions
PROCEDURECut-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.
PROCEDUREV-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.
DEVICEValleylab G3000 Electrosurgical Device
Use of surgical device Valleylab G3000 Electrosurgical Device
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Patient scheduled for total laparoscopic hysterectomy (TLH) 3. Signed informed consent
Exclusion criteria
1\. Known pelvic infection within 30 days prior to hysterectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy | up to 36 months | distance in millimeters over which thermal tissue injury extends (henceforth referred to as injury). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | 4 weeks, 3 months, and 6 months after hysterectomy for a post-operative check and pelvic examination | 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 |
Participant flow
Pre-assignment details
19 subjects either withdrew or were excluded from the study. Thermal injury could not be assessed in 18 specimens because of sampling error.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 49 |
| 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 | 52 |
| Total | 101 |
Baseline characteristics
| Characteristic | Cut/Coag | V-mode | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 9 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 43 Participants | 79 Participants |
| Age, Continuous | 58 years STANDARD_DEVIATION 12.5 | 54 years STANDARD_DEVIATION 11.9 | 56.3 years STANDARD_DEVIATION 12.3 |
| Body Mass Index | 33 kg/m^2 | 32 kg/m^2 | 32.5 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 51 Participants | 99 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 14 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 39 Participants | 36 Participants | 75 Participants |
| Region of Enrollment United States | 49 participants | 52 participants | 101 participants |
| Sex: Female, Male Female | 49 Participants | 52 Participants | 101 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 52 |
| serious Total, serious adverse events | 0 / 49 | 0 / 52 |
Outcome results
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).
Time frame: up to 36 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cut/Coag | Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy | Anterior Depth of thermal injury (mm) | 0.68 mm |
| Cut/Coag | Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy | Posterior Depth of thermal injury (mm) | 0.66 mm |
| V-mode | Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy | Anterior Depth of thermal injury (mm) | 0.63 mm |
| V-mode | Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy | Posterior Depth of thermal injury (mm) | 0.70 mm |
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
Time frame: 4 weeks, 3 months, and 6 months after hysterectomy for a post-operative check and pelvic examination
Population: This secondary objective was not evaluated
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cut/Coag | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Granulation Tissue 3 months post-op | 18 participants |
| Cut/Coag | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Vaginal cuff induration 6 months post-op | 0 participants |
| Cut/Coag | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Vaginal cuff induration 4 weeks post-op | 2 participants |
| Cut/Coag | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Vaginal cuff infection 4 weeks post-op | 4 participants |
| Cut/Coag | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Granulation Tissue 6 months post-op | 10 participants |
| Cut/Coag | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Vaginal cuff infection 3 months post-op | 0 participants |
| Cut/Coag | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Vaginal cuff induration 3 months post-op | 0 participants |
| Cut/Coag | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Vaginal cuff infection 6 months post-op | 0 participants |
| Cut/Coag | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Granulation Tissue 4 weeks post-op | 6 participants |
| V-mode | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Vaginal cuff infection 6 months post-op | 0 participants |
| V-mode | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Granulation Tissue 4 weeks post-op | 8 participants |
| V-mode | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Granulation Tissue 3 months post-op | 21 participants |
| V-mode | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Granulation Tissue 6 months post-op | 11 participants |
| V-mode | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Vaginal cuff induration 4 weeks post-op | 4 participants |
| V-mode | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Vaginal cuff induration 3 months post-op | 5 participants |
| V-mode | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Vaginal cuff induration 6 months post-op | 0 participants |
| V-mode | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Vaginal cuff infection 4 weeks post-op | 0 participants |
| V-mode | Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing | Vaginal cuff infection 3 months post-op | 10 participants |