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We hypothesize, that the use of the Hohl manipulatorĀ® 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 manipulatorĀ®, 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 manipulatorĀ® and the cervix of the uterus, which also affects speed of transection, electrosurgical device activation time and lateral thermal damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hohl uterine manipulator Ā® | Active Comparator | Total laparoscopic hysterectomy is performed using the Hohl uterine manipulator Ā® |
|
| Colpo-Probe⢠Vaginal Fornix Delineator | Active Comparator | Total laparoscopic hysterectomy is performed using the Colpo-Probe⢠Vaginal Fornix Delineator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of the Colpo-Probe⢠Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detachment of the uterus | Operative time from skin incision to detachment of uterus. Times are routinely collected by operating room nursing staff. | 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. | 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. | 3 minutes to 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Loss | Total amount of blood lost throughout surgery. Measured in cc. | 45 minutes to 3 hours |
| Pain | Amount of post operative pain measured using a pain sensitivity scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guylaine Lefebvre, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael“s Hospital | Toronto | Ontario | M5B 1W8 | Canada |
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| 24h post surgery |
| Manipulator Installment | intraoperative |