Comparing Two Devices of Uterine Manipulation and Vaginal Fornix Delineation at Total Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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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.

Official Title
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Comparing Two Devices of Uterine Manipulation and Vaginal Fornix Delineation at Total Laparoscopic Hysterectomy

Conditions
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Laparoscopic Hysterectomy for Benign Conditions

Intervention / Treatment
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* Device: Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: pregnancy malignancy if uterine size exceeds 20 weeks of gestation or if the uterus could be removed by a vaginal approach

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hohl uterine manipulator ®<br>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<br> <br> |
| Active Comparator: Colpo-Probe™ Vaginal Fornix Delineator<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 24h post surgery | 
| Manipulator Installment |  | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hysterectomy, uterine manipulator, thermal damage, laparoscopy, colpotomy