Laparoscopic Hysterectomy for Benign ConditionsNCT02197728
Comparing Two Devices of Uterine Manipulation and Vaginal Fornix Delineation at Total Laparoscopic Hysterectomy
A study testing Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy in people with Laparoscopic Hysterectomy for Benign Conditions, run by Unity Health Toronto at 1 site in Canada.
Trial summary
We hypothesize, that the use of the Hohl manipulator® at total laparoscopic hysterectomy reduces operative time (from skin incision to detachment of the uterus) and lateral termal damage of the vaginal wall during colpotomy due to the following reasons: (1) Uterine manipulation is better with the Hohl manipulator®… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Laparoscopic Hysterectomy for Benign Conditions
- What is being tested?
- Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All women aged over 18 years, scheduled for a laparoscopic hysterectomy for a benign disorder will be asked to participate and included after written informed consent.
Who cannot join
- pregnancy
- malignancy
- if uterine size exceeds 20 weeks of gestation
- or if the uterus could be removed by a vaginal approach
Trial locations and contacts
1 site in 1 country.
About this study
We hypothesize, that the use of the Hohl manipulator® at total laparoscopic hysterectomy reduces operative time (from skin incision to detachment of the uterus) and lateral termal damage of the vaginal wall during colpotomy due to the following reasons: (1) Uterine manipulation is better with the Hohl manipulator®, thereby facilitating dissection during all aspects of the surgery, (2) more tension can be applied on the vagina during colpotomy, thereby hastening electrosurgical transection, reducing activation time and reduce lateral thermal damage and (3) tension on the vagina can be applied until the colpotomy is finished, due to the tight connection between the Hohl manipulator® and the cervix of the uterus, which also affects speed of transection, electrosurgical device activation time and lateral thermal damage.
- Being tested
- Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy
- Keywords
- hysterectomy, uterine manipulator, thermal damage, laparoscopy, colpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomyDevice
| Study group | Role | What they receive |
|---|---|---|
| Hohl uterine manipulator ® | Active comparator | Total laparoscopic hysterectomy is performed using the Hohl uterine manipulator ® Receives: Device: Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy |
| Colpo-Probe™ Vaginal Fornix Delineator | Active comparator | Total laparoscopic hysterectomy is performed using the Colpo-Probe™ Vaginal Fornix Delineator Receives: Device: Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detachment of the uterus
Operative time from skin incision to detachment of uterus. Times are routinely collected by operating room nursing staff.
Measured: 45 minutes to 3 hours
Thermal Damage
Lateral thermal damage to the vagina will be measured on the specimen (in mm) at the time of pathologic evaluation.
Measured: 2 weeks post surgery
Colpotomy
Time from first monopolar energy activation to completion of colpotomy. Operative times are routinely collected by operating room nursing staff.
Measured: 3 minutes to 20 minutes
Secondary outcomes (3)
Blood Loss
Total amount of blood lost throughout surgery. Measured in cc.
Measured: 45 minutes to 3 hours
Pain
Amount of post operative pain measured using a pain sensitivity scale.
Measured: 24h post surgery
Manipulator Installment
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Hysterectomy for Benign ConditionsStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guylaine Lefebvre, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197728
- Sponsor's protocol ID
- 13-326
- Status last verified
- Feb 2019
- First submitted
- 23 May 2014
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Devices of Uterine Manipulation and Vaginal Fornix Delineation at Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT02197728
- Acronym / sponsor ID
- 13-326
- Keywords
- hysterectomy, uterine manipulator, thermal damage, laparoscopy, colpotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize, that the use of the Hohl manipulator® at total laparoscopic hysterectomy reduces operative time (from skin incision to detachment of the uterus) and lateral termal damage of the vaginal wall during colpotomy due to the following reasons: (1) Uterine manipulation is better with the Hohl manipulator®, thereby facilitating dissection during all aspects of the surgery, (2) more tension can be applied on the vagina during colpotomy, thereby hastening electrosurgical transection, reducing activation time and reduce lateral thermal damage and (3) tension on the vagina can be applied until the colpotomy is finished, due to the tight connection between the Hohl manipulator® and the cervix of the uterus, which also affects speed of transection, electrosurgical device activation time and lateral thermal damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hohl uterine manipulator ® | Active comparator | Device: Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomyTotal laparoscopic hysterectomy is performed using the Hohl uterine manipulator ® |
| Colpo-Probe™ Vaginal Fornix Delineator | Active comparator | Device: Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomyTotal laparoscopic hysterectomy is performed using the Colpo-Probe™ Vaginal Fornix Delineator |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women aged over 18 years, scheduled for a laparoscopic hysterectomy for a benign disorder will be asked to participate and included after written informed consent.
Key exclusion criteria (4 listed)
- pregnancy
- malignancy
- if uterine size exceeds 20 weeks of gestation
- or if the uterus could be removed by a vaginal approach
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 |
|---|---|---|
| Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy | Device | Colpo-Probe™ Vaginal Fornix Delineator, Hohl uterine manipulator ® |
Primary outcome
Detachment of the uterus
Time frame: 45 minutes to 3 hours
Operative time from skin incision to detachment of uterus. Times are routinely collected by operating room nursing staff.
Thermal Damage
Time frame: 2 weeks post surgery
Lateral thermal damage to the vagina will be measured on the specimen (in mm) at the time of pathologic evaluation.
Colpotomy
Time frame: 3 minutes to 20 minutes
Time from first monopolar energy activation to completion of colpotomy. Operative times are routinely collected by operating room nursing staff.
3 secondary outcomes
Blood Loss
Time frame: 45 minutes to 3 hours
Pain
Time frame: 24h post surgery
Manipulator Installment
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
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.
Guylaine Lefebvre, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy in people with Laparoscopic Hysterectomy for Benign Conditions, run by Unity Health Toronto at 1 site in Canada.
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 4 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 22 Feb 2019. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Detachment of the uterus (time frame: 45 minutes to 3 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2019; AzTrials last refreshed its copy on 8 Nov 2026.