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

Unity Health Toronto

Status: Completed

Conditions: Laparoscopic Hysterectomy for Benign Conditions

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02197728

13-326

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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91 participants in 2 patient groups

Hohl uterine manipulator ®

Active Comparator group

Description:

Total laparoscopic hysterectomy is performed using the Hohl uterine manipulator ®

Treatment:

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

Colpo-Probe™ Vaginal Fornix Delineator

Active Comparator group

Description:

Total laparoscopic hysterectomy is performed using the Colpo-Probe™ Vaginal Fornix Delineator

Treatment:

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