Trials / Completed
CompletedNCT02197728
Comparing Two Devices of Uterine Manipulation and Vaginal Fornix Delineation at Total Laparoscopic Hysterectomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 91 (actual)
- Sponsor
- Unity Health Toronto · Academic / Other
- Sex
- Female
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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®, 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2014-07-23
- Last updated
- 2019-02-22
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02197728. Inclusion in this directory is not an endorsement.