Laparoscopic Hysterectomy for Benign Conditions
Conditions
Keywords
hysterectomy, uterine manipulator, thermal damage, laparoscopy, colpotomy
Brief 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.
Interventions
DEVICEUse of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy
Sponsors
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detachment of the uterus | 45 minutes to 3 hours | Operative time from skin incision to detachment of uterus. Times are routinely collected by operating room nursing staff. |
| Thermal Damage | 2 weeks post surgery | Lateral thermal damage to the vagina will be measured on the specimen (in mm) at the time of pathologic evaluation. |
| Colpotomy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Loss | 45 minutes to 3 hours | Total amount of blood lost throughout surgery. Measured in cc. |
| Pain | 24h post surgery | Amount of post operative pain measured using a pain sensitivity scale. |
| Manipulator Installment | intraoperative | — |
Countries
Canada
Outcome results
None listed