FatigueNCT01707095
Bundling and Unbundling the Laparoscopic Electrosurgery Cord With the Camera Cord
A study testing Unbundling of cords and Bundling of cords in people with Fatigue, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Electrosurgery is used in virtually every laparoscopic operation performed. Capacitive coupling is a common electrosurgery complication. Previous work biopsying the skin adjacent to laparoscopic port sites is a method to determine if capacitive coupling thermal injury to the skin occurs during a laparoscopic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Unbundling of cords and Bundling of cords
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jan 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and older planned to undergo an elective laparoscopic cholecystectomy.
Who cannot join
- Patients undergoing urgent or emergent laparoscopic cholecystectomy operations
- Patients younger than 18
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Bundling and Unbundling the Laparoscopic Electrosurgery Cord With the Camera Cord: A Randomized, Controlled Trial
Electrosurgery is used in virtually every laparoscopic operation performed. Capacitive coupling is a common electrosurgery complication. Previous work biopsying the skin adjacent to laparoscopic port sites is a method to determine if capacitive coupling thermal injury to the skin occurs during a laparoscopic operation. [Willson et al. Surg Endosc (1997) 11:653] In our previous study, COMIRB 09-0049, we found thermal injury at 55% of umbilical trocar site skin biopsies and 35% of epigastric trocar site skin biopsies following laparoscopic cholecystectomy. Our benchtop research compared bundling of the camera cord with the active electrode cord versus unbundling of the camera cord with the active electrode cord and found a 59% decrease in heat generated in the unbundling experimental set-up. [Jones, EL, Robinson, TN, et al. Surg Endosc (2012) Epub.]
This study plans to compare thermal injury which occurs during two commonly used operating room set-ups. First, laparoscopic cholecystectomy with bundled camera/active electrode cords. And second, laparoscopic cholecystectomy with unbundled camera/active electrode cords. The primary outcome is the incidence of thermal injury at the skin adjacent to the camera port site (the umbilical port) that will be diagnosed by histology.
Read the detailed description
We hypothesize that the unbundling of camera and active electrode cords will reduce the incidence of capacitive coupling thermal injuries to the skin adjacent to the camera port site in comparison to bundled active electrodes/camera cords during laparoscopic cholecystectomy operations.
SPECIFIC AIMS:
- Compare incidence of skin burns by histology at the camera port site (umbilical port site) with bundled active electrode/camera cords to unbundled active electrode/camera cords.
- Compare incidence of skin burns by histology at the active electrode port site (epigastric port site) with bundled active electrode/camera cords to unbundled active electrode/camera cords.
- Compare incidence of skin burns by histology at the assistant port site with bundled active electrode/camera cords to unbundled active electrode/camera cords.
OUTCOME MEASURE:
Histologic evidence of thermal injury at the skin biopsy sites of the active electrode port, the camera port and the medial assistant port.
POPULATION TO BE ENROLLED:
Subjects undergoing elective cholecystectomy will be recruited in pre-operative clinic. All subjects will be 18 years and older.
STUDY DESIGN AND METHODS:
Written informed consent will be obtained in all subjects prior to enrollment. Subjects will be randomized on the day of surgery to undergo the laparoscopic cholecystectomy operation with either the bundled or unbundled camera and active electrode cords. The randomization process will occur by a random number generator. A total of 84 subjects will be recruited; 42 subjects per group. Shave skin biopsies will be performed at the lower edge of the incisions of the active electrode port, the camera port and the medial assistant port. The incisions and skin will be otherwise opened and closed in the routine clinical manner. The biopsy specimens will be analyzed for thermal injury by a blinded pathologist.
The incidence of skin burns created bundled or unbundled camera and active electrode cords will be compared individually at all three port sites by a blinded pathologist for histologic evidence of thermal injury.
Statistical analysis using a chi-squared test will be comparing the incidence of thermal injury at the each biopsy site for subjects with and without bundled cords. The primary outcome variable is thermal injury of skin at the umbilical trocar site, which is the camera trocar.
Baseline demographic information will be recorded on all patients: age, gender, BMI, operating room time, pre-op diagnosis, gallbladder histology, blood loss, and need to convert to open surgery.
SAMPLE SIZE CALCULATION:
The incidence of skin burns at the umbilical trocar site with bundled cords was 55% (11/20) in our previous study. Our prior benchtop research found that bundled cords resulted in an increase of temperature of 38.2°C at the tip of the telescope in comparison to a 15.7°C increase in temperature with separated cords. This finding suggests that 41% (15.7/38.2) of the heat is produced when the camera cord is unbundled from the active electrode cord in comparison to when the cords are bundled. This data is used to estimate that the unbundled cord group will have an incidence of thermal injury of 23% (0.41 x 55%).
Power 80% A sample size calculation comparing proportions was performed which compared 0.55 (bundled cords) incidence of thermal injury versus 0.23 (unbundled cords) incidence of thermal injury. A sample size of 36 per group has the power (1-β) 0.80 to detect a difference assuming α=0.05. We estimate a 15% dropout rate (this would be individuals who between their consent in pre-operative clinic and their operation decide to withdraw from the study). A 15% dropout rate is conservative in light of our prior experience recruiting similar patients when 0% (0/40) of individuals dropped out. Total sample size is estimated to be 72 (36 for each of two groups) plus 11 (15% dropout) for a total of 84 subjects.
STATISTICAL ANALYSIS:
The incidence of thermal injury to the skin (dichotomous variable) in the groups that had unbundled or bundled camera/active electrode cords will be compared using the Fischer's exact chi squared test.
- Conditions
- Fatigue
- Being tested
- Unbundling of cords, Bundling of cords
- Keywords
- Electrosurgery, Radiofrequency energy, Monopolar instruments, Capacitive coupling, Thermal injury, Surgical complications
- Medical subject headings
- Fatigue, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unbundling of cordsOther
The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another
Bundling of cordsOther
The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| Bundling of cords | Experimental | The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy. Receives: Other: Bundling of cords |
| Unbundling of cords | Experimental | The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another Receives: Other: Unbundling of cords |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologic Thermal Injury to Umbilical Port Site Skin
Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at these port sites.
Measured: 1 day
Secondary outcomes (1)
Histologic Evidence of Burn at the Epigastric Port Site Skin.
Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port site.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2014
- Study completionJan 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 (4)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas N Robinson, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707095
- Sponsor's protocol ID
- 12-0906
- Status last verified
- Jul 2014
- First submitted
- 21 Sep 2012
- Last updated
- 17 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Willson PD, van der Walt JD, Moxon D, Rogers J. Port site electrosurgical (diathermy) burns during surgical laparoscopy. Surg Endosc. 1997 Jun;11(6):653-4. doi: 10.1007/s004649900414.
PubMed 9171127Wu MP, Ou CS, Chen SL, Yen EY, Rowbotham R. Complications and recommended practices for electrosurgery in laparoscopy. Am J Surg. 2000 Jan;179(1):67-73. doi: 10.1016/s0002-9610(99)00267-6.
PubMed 10737583Jones EL, Robinson TN, McHenry JR, Dunn CL, Montero PN, Govekar HR, Stiegmann GV. Radiofrequency energy antenna coupling to common laparoscopic instruments: practical implications. Surg Endosc. 2012 Nov;26(11):3053-7. doi: 10.1007/s00464-012-2312-6. Epub 2012 May 12.
PubMed 22580879Robinson TN, Jones EL, Dunn CL, Dunne B, Johnson E, Townsend NT, Paniccia A, Stiegmann GV. Separating the Laparoscopic Camera Cord From the Monopolar "Bovie" Cord Reduces Unintended Thermal Injury From Antenna Coupling: A Randomized Controlled Trial. Ann Surg. 2015 Jun;261(6):1056-60. doi: 10.1097/SLA.0000000000000841.
PubMed 26291952
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bundling and Unbundling the Laparoscopic Electrosurgery Cord With the Camera Cord: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01707095
- Acronym / sponsor ID
- 12-0906
- Conditions
- Fatigue
- Keywords
- Electrosurgery, Radiofrequency energy, Monopolar instruments, Capacitive coupling, Thermal injury, Surgical complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Posted 27 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Electrosurgery is used in virtually every laparoscopic operation performed. Capacitive coupling is a common electrosurgery complication. Previous work biopsying the skin adjacent to laparoscopic port sites is a method to determine if capacitive coupling thermal injury to the skin occurs during a laparoscopic operation. [Willson et al. Surg Endosc (1997) 11:653] In our previous study, COMIRB 09-0049, we found thermal injury at 55% of umbilical trocar site skin biopsies and 35% of epigastric trocar site skin biopsies following laparoscopic cholecystectomy. Our benchtop research compared bundling of the camera cord with the active electrode cord versus unbundling of the camera cord with the active electrode cord and found a 59% decrease in heat generated in the unbundling experimental set-up. [Jones, EL, Robinson, TN, et al. Surg Endosc (2012) Epub.]
This study plans to compare thermal injury which occurs during two commonly used operating room set-ups. First, laparoscopic cholecystectomy with bundled camera/active electrode cords. And second, laparoscopic cholecystectomy with unbundled camera/active electrode cords. The primary outcome is the incidence of thermal injury at the skin adjacent to the camera port site (the umbilical port) that will be diagnosed by histology.
Detailed description
We hypothesize that the unbundling of camera and active electrode cords will reduce the incidence of capacitive coupling thermal injuries to the skin adjacent to the camera port site in comparison to bundled active electrodes/camera cords during laparoscopic cholecystectomy operations.
SPECIFIC AIMS:
- Compare incidence of skin burns by histology at the camera port site (umbilical port site) with bundled active electrode/camera cords to unbundled active electrode/camera cords.
- Compare incidence of skin burns by histology at the active electrode port site (epigastric port site) with bundled active electrode/camera cords to unbundled active electrode/camera cords.
- Compare incidence of skin burns by histology at the assistant port site with bundled active electrode/camera cords to unbundled active electrode/camera cords.
OUTCOME MEASURE:
Histologic evidence of thermal injury at the skin biopsy sites of the active electrode port, the camera port and the medial assistant port.
POPULATION TO BE ENROLLED:
Subjects undergoing elective cholecystectomy will be recruited in pre-operative clinic. All subjects will be 18 years and older.
STUDY DESIGN AND METHODS:
Written informed consent will be obtained in all subjects prior to enrollment. Subjects will be randomized on the day of surgery to undergo the laparoscopic cholecystectomy operation with either the bundled or unbundled camera and active electrode cords. The randomization process will occur by a random number generator. A total of 84 subjects will be recruited; 42 subjects per group. Shave skin biopsies will be performed at the lower edge of the incisions of the active electrode port, the camera port and the medial assistant port. The incisions and skin will be otherwise opened and closed in the routine clinical manner. The biopsy specimens will be analyzed for thermal injury by a blinded pathologist.
The incidence of skin burns created bundled or unbundled camera and active electrode cords will be compared individually at all three port sites by a blinded pathologist for histologic evidence of thermal injury.
Statistical analysis using a chi-squared test will be comparing the incidence of thermal injury at the each biopsy site for subjects with and without bundled cords. The primary outcome variable is thermal injury of skin at the umbilical trocar site, which is the camera trocar.
Baseline demographic information will be recorded on all patients: age, gender, BMI, operating room time, pre-op diagnosis, gallbladder histology, blood loss, and need to convert to open surgery.
SAMPLE SIZE CALCULATION:
The incidence of skin burns at the umbilical trocar site with bundled cords was 55% (11/20) in our previous study. Our prior benchtop research found that bundled cords resulted in an increase of temperature of 38.2°C at the tip of the telescope in comparison to a 15.7°C increase in temperature with separated cords. This finding suggests that 41% (15.7/38.2) of the heat is produced when the camera cord is unbundled from the active electrode cord in comparison to when the cords are bundled. This data is used to estimate that the unbundled cord group will have an incidence of thermal injury of 23% (0.41 x 55%).
Power 80% A sample size calculation comparing proportions was performed which compared 0.55 (bundled cords) incidence of thermal injury versus 0.23 (unbundled cords) incidence of thermal injury. A sample size of 36 per group has the power (1-β) 0.80 to detect a difference assuming α=0.05. We estimate a 15% dropout rate (this would be individuals who between their consent in pre-operative clinic and their operation decide to withdraw from the study). A 15% dropout rate is conservative in light of our prior experience recruiting similar patients when 0% (0/40) of individuals dropped out. Total sample size is estimated to be 72 (36 for each of two groups) plus 11 (15% dropout) for a total of 84 subjects.
STATISTICAL ANALYSIS:
The incidence of thermal injury to the skin (dichotomous variable) in the groups that had unbundled or bundled camera/active electrode cords will be compared using the Fischer's exact chi squared test.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bundling of cords | Experimental | Other: Bundling of cordsThe cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy. |
| Unbundling of cords | Experimental | Other: Unbundling of cordsThe active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 years and older planned to undergo an elective laparoscopic cholecystectomy.
Key exclusion criteria (2 listed)
- Patients undergoing urgent or emergent laparoscopic cholecystectomy operations
- Patients younger than 18
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 |
|---|---|---|
| Unbundling of cordsThe active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another | Other | Unbundling of cords |
| Bundling of cordsThe cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy. | Other | Bundling of cords |
Primary outcome
Histologic Thermal Injury to Umbilical Port Site Skin
Time frame: 1 day
Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at these port sites.
1 secondary outcome
Histologic Evidence of Burn at the Epigastric Port Site Skin.
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9171127Willson PD, van der Walt JD, Moxon D, Rogers J. Port site electrosurgical (diathermy) burns during surgical laparoscopy. Surg Endosc. 1997 Jun;11(6):653-4. doi: 10.1007/s004649900414.
- Background: PubMed 10737583Wu MP, Ou CS, Chen SL, Yen EY, Rowbotham R. Complications and recommended practices for electrosurgery in laparoscopy. Am J Surg. 2000 Jan;179(1):67-73. doi: 10.1016/s0002-9610(99)00267-6.
- Background: PubMed 22580879Jones EL, Robinson TN, McHenry JR, Dunn CL, Montero PN, Govekar HR, Stiegmann GV. Radiofrequency energy antenna coupling to common laparoscopic instruments: practical implications. Surg Endosc. 2012 Nov;26(11):3053-7. doi: 10.1007/s00464-012-2312-6. Epub 2012 May 12.
- Derived from this study: PubMed 26291952Robinson TN, Jones EL, Dunn CL, Dunne B, Johnson E, Townsend NT, Paniccia A, Stiegmann GV. Separating the Laparoscopic Camera Cord From the Monopolar "Bovie" Cord Reduces Unintended Thermal Injury From Antenna Coupling: A Randomized Controlled Trial. Ann Surg. 2015 Jun;261(6):1056-60. doi: 10.1097/SLA.0000000000000841.
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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.
Thomas N Robinson, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unbundling of cords and Bundling of cords in people with Fatigue, run by University of Colorado, Denver at 1 site in United States.
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 1 inclusion and 2 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 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 27 Jun 2014). 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?
Histologic Thermal Injury to Umbilical Port Site Skin (time frame: 1 day). 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 NCT01707095, which also lists 4 linked publications.
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 17 Jul 2014.