St. Michael´s Hospital
Toronto, Ontario, M5B 1W8, Canada
NCT Number: NCT02197728
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.
Looking for future studies?
Notify Me18 year–80 year
Female
Interventional
Not applicable
Toronto, Ontario, M5B 1W8, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 45 minutes to 3 hours
Total amount of blood lost throughout surgery. Measured in cc.
Time frame: 24h post surgery
Amount of post operative pain measured using a pain sensitivity scale.
Time frame: intraoperative
Unity Health Toronto
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.