Vaginal Cuff DehiscenceNCT02080546
Vaginal Cuff Dehiscence and Thermal Injury During TLH
A study testing Cut-Coag, V-mode and Valleylab G3000 Electrosurgical Device in people with Vaginal Cuff Dehiscence and Thermal Injury, run by Duke University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Cuff Dehiscence, Thermal Injury
- What is being tested?
- Cut-Coag, V-mode and Valleylab G3000 Electrosurgical Device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Patient scheduled for total laparoscopic hysterectomy (TLH)
- Signed informed consent
Who cannot join
- 1. Known pelvic infection within 30 days prior to hysterectomy
About this study
Official title: Vaginal Cuff Dehiscence and Thermal Injury at the Time of Total Laparoscopic Hysterectomy: A Review of the Duke Experience and Randomized Controlled Trial
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.
- Conditions
- Vaginal Cuff Dehiscence, Thermal Injury
- Being tested
- Cut-Coag, V-mode, Valleylab G3000 Electrosurgical Device
- Keywords
- Vaginal cuff dehiscence, Thermal Injury, Total laparoscopic hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cut-CoagProcedure or surgery
Also called Valleylab G3000 Electrosurgical Device
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.
V-modeProcedure or surgery
Also called Valleylab G3000 Electrosurgical Device
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 DeviceDevice
Use of surgical device Valleylab G3000 Electrosurgical Device
| Study group | Role | What they receive |
|---|---|---|
| Cut/Coag | Active comparator | Not described Receives: Procedure: Cut-Coag; Device: Valleylab G3000 Electrosurgical Device |
| V-mode | Experimental | Not described Receives: Procedure: V-mode; Device: Valleylab G3000 Electrosurgical Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy
distance in millimeters over which thermal tissue injury extends (henceforth referred to as "injury").
Measured: up to 36 months
Secondary outcomes (1)
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
Measured: 4 weeks, 3 months, and 6 months after hysterectomy for a post-operative check and pelvic examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startDec 2009
- Primary completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginal Cuff DehiscenceStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula S Lee, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080546
- Sponsor's protocol ID
- Pro00019452
- Status last verified
- Jan 2016
- First submitted
- 3 Mar 2014
- Last updated
- 3 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 25305572
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Cuff Dehiscence and Thermal Injury at the Time of Total Laparoscopic Hysterectomy: A Review of the Duke Experience and Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02080546
- Acronym / sponsor ID
- Pro00019452
- Conditions
- Vaginal Cuff Dehiscence, Thermal Injury
- Keywords
- Vaginal cuff dehiscence, Thermal Injury, Total laparoscopic hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Feb 2014 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Posted 3 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cut/Coag | Active comparator | Procedure: Cut-Coag, Device: Valleylab G3000 Electrosurgical Device |
| V-mode | Experimental | Procedure: V-mode, Device: Valleylab G3000 Electrosurgical Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Patient scheduled for total laparoscopic hysterectomy (TLH)
- Signed informed consent
Key exclusion criteria (1 listed)
- 1. Known pelvic infection within 30 days prior to hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cut-CoagAlso: Valleylab G3000 Electrosurgical DeviceIncision 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. | Procedure or surgery | Cut/Coag |
| V-modeAlso: Valleylab G3000 Electrosurgical DeviceIncision 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. | Procedure or surgery | V-mode |
| Valleylab G3000 Electrosurgical DeviceUse of surgical device Valleylab G3000 Electrosurgical Device | Device | Cut/Coag, V-mode |
Primary outcome
Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy
Time frame: up to 36 months
distance in millimeters over which thermal tissue injury extends (henceforth referred to as "injury").
1 secondary outcome
Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing
Time frame: 4 weeks, 3 months, and 6 months after hysterectomy for a post-operative check and pelvic examination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25305572Teoh 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula S Lee, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing Cut-Coag, V-mode and Valleylab G3000 Electrosurgical Device in people with Vaginal Cuff Dehiscence and Thermal Injury, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02080546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2016.