An interventional study of Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy in Laparoscopic Hysterectomy for Benign Conditions, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-02-22.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Treatment
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.
Unity Health Toronto is the lead sponsor of 444 studies on the registry; 80 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Total laparoscopic hysterectomy is performed using the Hohl uterine manipulator ®
Device: Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy
Total laparoscopic hysterectomy is performed using the Colpo-Probe™ Vaginal Fornix Delineator
Device: Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy
Detachment of the uterus
Operative time from skin incision to detachment of uterus. Times are routinely collected by operating room nursing staff.
Time frame: 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.
Time frame: 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.
Time frame: 3 minutes to 20 minutes
Blood Loss
Total amount of blood lost throughout surgery. Measured in cc.
Time frame: 45 minutes to 3 hours
Pain
Amount of post operative pain measured using a pain sensitivity scale.
Time frame: 24h post surgery
Manipulator Installment
Time frame: intraoperative
The record gives a start of Feb 2014, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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